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Burkus, J. Kenneth, Kevin Foley, Regis Haid, and Jean-Charles LeHuec. "Surgical Interbody Research Group–radiographic assessment of interbody fusion devices: fusion criteria for anterior lumbar interbody surgery." Neurosurgical Focus 10, no. 4 (April 2001): 1–9. http://dx.doi.org/10.3171/foc.2001.10.4.12.
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The authors present their radiographic criteria for assessing fusion of the lumbar spine after anterior interbody fusion with intradiscal implants. These criteria include the assessment of plain radiographs, dynamic motion radiographs, and thin-cut computerized tomography scans. Fusion within the instrumented spinal motion segment can be determined using radiographic evaluation to assess spinal alignment on sequential examinations, angular and translational changes on dynamic motion studies, and device–host interface, and to identify new bone formation and bone remodeling. Finally, to aid the clinician in assessing fusion, the authors describe the five zones of fusion within the intervertebral disc space.
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Toth, Jeffrey M., Bradley T. Estes, Mei Wang, Howard B. Seim, Jeffrey L. Scifert, A. Simon Turner, and G. Bryan Cornwall. "Evaluation of 70/30 poly (l-lactide-co-d,l-lactide) for use as a resorbable interbody fusion cage." Journal of Neurosurgery: Spine 97, no. 4 (November 2002): 423–32. http://dx.doi.org/10.3171/spi.2002.97.4.0423.
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Object. Titanium lumbar interbody spinal fusion devices are reported to be 90% effective in cases requiring single-level lumbar interbody arthrodesis, although radiographic determination of fusion has been debated. Methods. Using blinded radiographic, biomechanical, histological, and statistical measures, researchers in the present study evaluated a radiolucent 70/30 poly(l-lactide-co-d,l-lactide) interbody fusion device packed with autograft or recombinant human bone morphogenetic protein—2 on a collagen sponge in 25 sheep at 3, 6, 12, 18, and 24 months. A trend of increased fusion stiffness, radiographic fusion, and histologically confirmed fusion was demonstrated at 3 months to 24 months postimplantation. Device degradation was associated with a mild to moderate chronic inflammatory response at all postoperative sacrifice times. Conclusions. Use of this material in interbody fusion may be a viable alternative to metals.
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Feng, Shitong, Zihan Fan, Jiashuai Ni, Yong Yang, and Qi Fei. "New combination of IntraSPINE device and posterior lumbar interbody fusion for rare skipped-level lumbar disc herniation: a case report and literature review." Journal of International Medical Research 48, no. 8 (August 2020): 030006052094976. http://dx.doi.org/10.1177/0300060520949764.
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Posterior lumbar interbody fusion is an open surgical technique that has been widely used for the treatment of degenerative lumbar disease. However, traditional lumbar spinal fusion, especially long-segment fusion surgery, is associated with several complications. The IntraSPINE (Cousin Biotech, Wervicq-Sud, France) is a new device for non-fusion lumbar spine surgery that is used as an alternative for the treatment of degenerative lumbar disease. Although the designer of the IntraSPINE proposed indications for its use, including combination of the device with lumbar spinal fusion for the treatment of degenerative lumbar disease, use of the IntraSPINE has not been reported in the clinical literature. In the present case, we boldly combined the IntraSPINE device and posterior lumbar interbody fusion for the treatment of skipped-level lumbar disc herniation to explore the indications of the IntraSPINE and report its clinical outcomes.
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Kumar Mishra, Sandeep, Kushal Haresh Gori, and Deepak C. E. "Comparison of outcome in lumbar spine instability treated surgically with pedicle screw fixation with or without interbody fusion device (cage)." International Journal of Research in Medical Sciences 6, no. 3 (February 22, 2018): 937. http://dx.doi.org/10.18203/2320-6012.ijrms20180619.
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Background: Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis. Broader applications including use as a treatment of chronic low back pain and recurrent radiculopathy have resulted in a dramatic increase in the rates of lumbar fusion procedures within the last decade.Methods: A retrospective and prospective study to be carried out for 40 patients who were assigned in the following groups: Group 1 (n=20) consisted of patients who underwent lumbar interbody fusion with pedicle screw and bone graft, and Group 2 (n=20) consisted of patients treated by lumbar interbody fusion with pedicle screw and interbody cage.Results: Most of patients with lumbar spine instability were in 4th and 5th decade of life with average age of 46.75 yrs and female predominance with 26 (65%) cases.65% of Instability was found due to Spondylolisthesis. PLIF with Cage showed better scores than BG in terms of ODI, VAS, SF-36, Benzel’s modified Japanese scores at end of 1 year, which is statistically not significant.Conclusions: Lumbar spine instability is more common in 4th and 5th decade of life with female predominance, commonest level of instability being L4-L5 and commonest mode was Spondylolisthesis. PLIF with Cage is associated with greater operative time and lesser blood loss. Patients with PLIF + Cage had better neurological improvement, pain reduction, reduced disability, generalised well-being and satisfaction as evident by Modified Benzel’s Japanese scales, VAS, ODI, and SF-36 scores respectively, which is statistically not significant. Addition of an interbody fusion device (Cage) helps in greater stability, lower implant failure, higher fusion rate and better functional outcome in patient treated with PLIF for lumbar spine instability.
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Spicher, Anna, Werner Schmoelz, Rene Schmid, Hannes Stofferin, and Niall J. A. Craig. "Functional and radiographic evaluation of an interspinous device as an adjunct for lumbar interbody fusion procedures." Biomedical Engineering / Biomedizinische Technik 65, no. 2 (April 28, 2020): 183–89. http://dx.doi.org/10.1515/bmt-2018-0086.
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AbstractIn the last decades, several interspinous process devices were designed as a minimally invasive treatment option for spinal stenosis. In order to minimise surgical trauma, interspinous process devices were recently discussed as an alternative posterior fixation in vertebral interbody fusions. Therefore, the purpose of this study was to evaluate the effect of a newly designed interspinous device with polyester bands (PBs) on range of motion (RoM) and centre of rotation (CoR) of a treated motion segment in comparison with an established interspinous device with spikes (SC) as well as with pedicle screw instrumentation in lumbar fusion procedures. Flexibility tests with an applied pure moment load of 7.5 Nm were performed in six monosegmental thoracolumbar functional spinal units (FSUs) in the following states: (a) native, (b) native with PB device, (c) intervertebral cage with PB device, (d) cage with SC and (e) cage with internal fixator. The resulting RoM was normalised to the native RoM. The CoR was determined of X-ray images taken in maximal flexion and extension during testing. In flexion and extension, the PB device without and with the cage reduced the RoM of the native state to 58% [standard deviation (SD) 17.8] and 53% (SD 15.7), respectively. The SC device further reduced the RoM to 27% (SD 16.8), while the pedicle screw instrumentation had the most reducing effect to 17% (SD 17.2) (p < 0.01). In lateral bending and axial rotation, the interspinous devices had the least effect on the RoM. Compared to the native state, for all instrumentations the CoR showed a small shift towards cranial. In the anterior-posterior direction, the SC device and the pedicle screw instrumentation shifted the CoR towards the posterior wall. The interspinous devices significantly reduced the RoM in flexion/extension, while in axial rotation and lateral bending only the internal fixator had a significant effect on the RoM.
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Crawford, Brooke, Christopher Lenarz, J. Tracy Watson, and Dirk Alander. "Complication with Removal of a Lumbar Spinal Locking Plate." Case Reports in Orthopedics 2015 (2015): 1–4. http://dx.doi.org/10.1155/2015/787249.
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Introduction. The use of locking plate technology for anterior lumbar spinal fusion has increased stability of the vertebral fusion mass over traditional nonconstrained screw and plate systems. This case report outlines a complication due to the use of this construct.Case. A patient with a history of L2 corpectomy and anterior spinal fusion presented with discitis at the L4/5 level and underwent an anterior lumbar interbody fusion (ALIF) supplemented with a locking plate placed anterolaterally for stability. Fifteen months after the ALIF procedure, he returned with a hardware infection. He underwent debridement of the infection site and removal of hardware.Results. Once hardware was exposed, removal of the locking plate screws was only successful in one out of four screws using a reverse thread screw removal device. Three of the reverse thread screw removal devices broke in attempt to remove the subsequent screws. A metal cutting drill was then used to break hoop stresses associated with the locking device and the plate was removed.Conclusion. Anterior locking plates add significant stability to an anterior spinal fusion mass. However, removal of this hardware can be complicated by the inherent properties of the design with significant risk of major vascular injury.
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Kumar, Manoj, Prashanth Dhanraj, and Deepak Shivanna. "Results of Anterior Spinal Fusion in Spondylolisthesis with or without Interbody Fusion Device (CAGE)." Global Spine Journal 5, no. 1_suppl (May 2015): s—0035–1554311—s—0035–1554311. http://dx.doi.org/10.1055/s-0035-1554311.
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Cadel, Eileen, Ember Krech, Paul Arnold, and Elizabeth Friis. "Stacked PZT Discs Generate Necessary Power for Bone Healing through Electrical Stimulation in a Composite Spinal Fusion Implant." Bioengineering 5, no. 4 (October 23, 2018): 90. http://dx.doi.org/10.3390/bioengineering5040090.
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Electrical stimulation devices can be used as adjunct therapy to lumbar spinal fusion to promote bone healing, but their adoption has been hindered by the large battery packs necessary to provide power. Piezoelectric composite materials within a spinal interbody cage to produce power in response to physiological lumbar loads have recently been investigated. A piezoelectric macro-fiber composite spinal interbody generated sufficient power to stimulate bone growth in a pilot ovine study, despite fabrication challenges. The objective of the present study was to electromechanically evaluate three new piezoelectric disc composites, 15-disc insert, seven-disc insert, and seven-disc Compliant Layer Adaptive Composite Stack (CLACS) insert, within a spinal interbody, and validate their use for electrical stimulation and promoting bone growth. All implants were electromechanically assessed under cyclic loads of 1000 N at 2 Hz, representing physiological lumbar loading. All three configurations produced at least as much power as the piezoelectric macro-fiber composites, validating the use of piezoelectric discs for this application. Future work is needed to characterize the electromechanical performance of commercially manufactured piezoelectric stacks under physiological lumbar loads, and mechanically assess the composite implants according to FDA guidelines for lumbar interbody fusion devices.
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Alexander, Joseph T., Charles L. Branch, Brian R. Subach, and Regis W. Haid. "Applications of a resorbable interbody spacer in posterior lumbar interbody fusion." Journal of Neurosurgery: Spine 97, no. 4 (November 2002): 468–72. http://dx.doi.org/10.3171/spi.2002.97.4.0468.
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✓ Polyhydroxy acids are a promising class of resorbable materials with potential applications in spinal surgery. One such polymer, MacroPore (MacroPore Biosurgery, Inc.), offers a balance of strength, predictable degradation, lack of stimulus of foreign body reaction, and biocompatibility with neural tissue. MacroPore can be formed into an array of shapes and can be manufactured, sterilized, and stored using conventional techniques. Limited clinical experience has been gained with resorbable implants used as load-sharing devices in a posterior lumbar interbody fusion construct.
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Takemoto, Mitsuru, Shunsuke Fujibayashi, Masashi Neo, Kazutaka So, Norihiro Akiyama, Tomiharu Matsushita, Tadashi Kokubo, and Takashi Nakamura. "A porous bioactive titanium implant for spinal interbody fusion: an experimental study using a canine model." Journal of Neurosurgery: Spine 7, no. 4 (October 2007): 435–43. http://dx.doi.org/10.3171/spi-07/10/435.
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Object Porous biomaterials with adequate pore structure and appropriate mechanical properties are expected to provide a new generation of devices for spinal interbody fusion because of their potential to eliminate bone grafting. The purpose of this study was to evaluate the fusion characteristics of porous bioactive titanium implants using a canine anterior interbody fusion model. Methods Porous titanium implants sintered with volatile spacer particles (porosity 50%, average pore size 303 μm, compressive strength 116.3 MPa) were subjected to chemical and thermal treatments that give a bioactive microporous titania layer on the titanium surface (BT implant). Ten adult female beagle dogs underwent anterior lumbar interbody fusion at L6–7 using either BT implants or nontreated (NT) implants, followed by posterior spinous process wiring and facet screw fixation. Radiographic evaluations were performed at 1, 2, and 3 months postoperatively using X-ray fluoroscopy. Animals were killed 3 months postoperatively, and fusion status was evaluated by manual palpation and histological examination. Results Interbody fusion was confirmed in all five dogs in the BT group and three of five dogs in the NT group. Histological examination demonstrated a large amount of new bone formation with marrowlike tissue in the BT implants and primarily fibrous tissue formation in the NT implants. Conclusions Bioactive treatment effectively enhanced the fusion ability of the porous titanium implants. These findings, coupled with the appropriate mechanical properties in load-bearing conditions, indicate that these porous bioactive titanium implants represent a new generation of biomaterial for spinal interbody fusion.
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Cunningham, Bryan W., Brent L. Atkinson, Nianbin Hu, Jun Kikkawa, Louis Jenis, Joseph Bryant, Paul O. Zamora, and Paul C. McAfee. "Ceramic granules enhanced with B2A peptide for lumbar interbody spine fusion: an experimental study using an instrumented model in sheep." Journal of Neurosurgery: Spine 10, no. 4 (April 2009): 300–307. http://dx.doi.org/10.3171/2009.1.spine08565.
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Object New generations of devices for spinal interbody fusion are expected to arise from the combined use of bioactive peptides and porous implants. The purpose of this dose-ranging study was to evaluate the fusion characteristics of porous ceramic granules (CGs) coated with the bioactive peptide B2A2-K-NS (B2A) by using a model of instrumented lumbar interbody spinal fusion in sheep. Methods Instrumented spinal arthrodesis was performed in 40 operative sites in 20 adult sheep. In each animal, posterior instrumentation (pedicle screw and rod) and a polyetheretherketone cage were placed in 2 single-level procedures (L2–3 and L4–5). All cages were packed with graft material prior to implantation. The graft materials were prepared by mixing (1:1 vol/vol) CGs with or without a B2A coating and morselized autograft. Ceramic granules were coated with B2A at 50, 100, 300, and 600 μg/ml granules (50-B2A/CG, 100-B2A/CG, 300-B2A/CG, and 600-B2A/CG, respectively), resulting in 4 B2A-coated groups plus a control group (uncoated CGs). Graft material from each of these groups was implanted in 8 operative sites. Four months after arthrodesis, interbody fusion status was assessed with CT, and the interbody site was further evaluated with quantitative histomorphometry. Results All B2A/CG groups had higher CT-confirmed interbody fusion rates compared with those in controls (CGs only). Seven of 8 sites were fused in the 50-B2A/CG, 100-B2A/CG, and 300-B2A/CG groups, whereas 5 of 8 sites were fused in the group that had received uncoated CGs. New woven and lamellar bone spanned the fusion sites with excellent osseointegration. There was no heterotopic ossification or other untoward events attributed to the use of B2A/CG in any group. Each B2A/CG treatment produced more new bone than that in the CG group. Conclusions Bioactive treatment with B2A effectively enhanced the fusion capacity of porous CGs. These findings suggest that B2A/CG may well represent a new generation of biomaterials for lumbar interbody fusion and indicate that additional studies are warranted.
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Neal, Matthew T., Maziyar A. Kalani, and Mark K. Lyons. "A Technical Nuance to Avoid Lumbar Five Radiculopathy with Anterior Lumbar Fusion and Posterior Instrumentation." Case Reports in Orthopedics 2021 (March 24, 2021): 1–4. http://dx.doi.org/10.1155/2021/5514720.
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The anterior lumbar interbody fusion (ALIF) is a well-established procedure used to treat a multitude of spinal pathologies. When performed at the L5-S1 level, the ALIF is often supplemented with posterior pedicle screw and rod fixation. Because the interbody device can restore disk and foraminal height, one benefit of the ALIF procedure is indirect neural decompression in the spinal canal and neural foramina. If the contour of the posterior rod is not matched to the exact position of the tulip heads on the pedicle screws, spondylolisthesis can be introduced, leading to foraminal stenosis and nerve compression. This concern is particularly germane when the posterior instrumentation is placed percutaneously without any direct foraminal decompression. In this report, we describe a patient who had an L4-S1 ALIF, resulting in new L5-S1 retrolisthesis and worsening L5 radiculopathy. Technical nuances and avoidance strategies are discussed.
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Khalifeh, Jawad M., Christopher F. Dibble, Priscilla Stecher, Ian Dorward, Ammar H. Hawasli, and Wilson Z. Ray. "Transfacet Minimally Invasive Transforaminal Lumbar Interbody Fusion With an Expandable Interbody Device—Part I: 2-Dimensional Operative Video and Technical Report." Operative Neurosurgery 19, no. 5 (May 20, 2020): E473—E479. http://dx.doi.org/10.1093/ons/opaa100.
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Abstract BACKGROUND Advances in operative techniques and minimally invasive technologies have evolved to maximize patient outcomes and radiographic results, while reducing morbidity and recovery time. OBJECTIVE To describe the operative technique for a transfacet minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) as a proposed modification to the standard approach MIS-TLIF. METHODS We present the case of a 72-yr-old man with left-sided lumbar radiculopathy. Preoperative imaging demonstrated degenerative lumbar anterolisthesis at L4-5, with associated canal and neuroforaminal stenosis. The patient underwent transfacet MIS-TLIF at L4-L5. We describe the preoperative planning, patient positioning, incision and dissection, pedicle screw insertion, transfacet approach to the working access corridor, discectomy, interbody device placement, fixation, and closure. RESULTS The transfacet MIS-TLIF utilizes 3 key techniques to safely maximize surgical correction: (1) a limited bony resection based on the superior articular process, leaving the medial inferior articular process, lateral superior articular process, and rostral pars intact, providing a working bony corridor that protects the traversing and exiting nerve roots; (2) decortication and release of the contralateral facet joint to provide additional capacity for indirect decompression and provide the first point of osseous fusion; and (3) placement of an expandable interbody device that provides additional indirect decompression to the working side and contralateral foramen. CONCLUSION The transfacet MIS-TLIF uniquely leverages a bony working corridor to access the disc space for discectomy and interbody placement. Transfacet MIS-TLIF is a feasible solution for lumbar spinal reconstruction to maximize direct and indirect decompression of the neuroforamina and central spinal canal in patients with lumbar degenerative diseases and low-grade spondylolisthesis.
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Lowe, Thomas G., and Jeffrey D. Coe. "Resorbable polymer implants in unilateral transforaminal lumbar interbody fusion." Journal of Neurosurgery: Spine 97, no. 4 (November 2002): 464–67. http://dx.doi.org/10.3171/spi.2002.97.4.0464.
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Object. Sixty patients underwent instrumentation-assisted posterior transforaminal lumbar interbody fusion (TLIF) with resorbable polymer cages and autograft bone for degenerative disease. This article discusses the technique of TLIF and its early outcomes. Methods. Although the follow-up period is short and results are preliminary, no adverse events or complications were attributed to the resorbable polymer. Conclusions. Further multicenter clinical studies are underway with a minimum 2-year follow-up period chosen as an endpoint to provide insight as to the future of biodegradable polymers as spinal interbody devices.
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Mummaneni, Praveen V., Ibrahim Hussain, Christopher I. Shaffrey, Robert K. Eastlack, Gregory M. Mundis, Juan S. Uribe, Richard G. Fessler, et al. "The minimally invasive interbody selection algorithm for spinal deformity." Journal of Neurosurgery: Spine 34, no. 5 (May 2021): 741–48. http://dx.doi.org/10.3171/2020.9.spine20230.
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OBJECTIVE Minimally invasive surgery (MIS) for spinal deformity uses interbody techniques for correction, indirect decompression, and arthrodesis. Selection criteria for choosing a particular interbody approach are lacking. The authors created the minimally invasive interbody selection algorithm (MIISA) to provide a framework for rational decision-making in MIS for deformity. METHODS A retrospective data set of circumferential MIS (cMIS) for adult spinal deformity (ASD) collected over a 5-year period was analyzed by level in the lumbar spine to identify surgeon preferences and evaluate segmental lordosis outcomes. These data were used to inform a Delphi session of minimally invasive deformity surgeons from which the algorithm was created. The algorithm leads to 1 of 4 interbody approaches: anterior lumbar interbody fusion (ALIF), anterior column release (ACR), lateral lumbar interbody fusion (LLIF), and transforaminal lumbar interbody fusion (TLIF). Preoperative and 2-year postoperative radiographic parameters and clinical outcomes were compared. RESULTS Eleven surgeons completed 100 cMISs for ASD with 338 interbody devices, with a minimum 2-year follow-up. The type of interbody approach used at each level from L1 to S1 was recorded. The MIISA was then created with substantial agreement. The surgeons generally preferred LLIF for L1–2 (91.7%), L2–3 (85.2%), and L3–4 (80.7%). ACR was most commonly performed at L3–4 (8.4%) and L2–3 (6.2%). At L4–5, LLIF (69.5%), TLIF (15.9%), and ALIF (9.8%) were most commonly utilized. TLIF and ALIF were the most selected approaches at L5–S1 (61.4% and 38.6%, respectively). Segmental lordosis at each level varied based on the approach, with greater increases reported using ALIF, especially at L4–5 (9.2°) and L5–S1 (5.3°). A substantial increase in lordosis was achieved with ACR at L2–3 (10.9°) and L3–4 (10.4°). Lateral interbody arthrodesis without the use of an ACR did not generally result in significant lordosis restoration. There were statistically significant improvements in lumbar lordosis (LL), pelvic incidence–LL mismatch, coronal Cobb angle, and Oswestry Disability Index at the 2-year follow-up. CONCLUSIONS The use of the MIISA provides consistent guidance for surgeons who plan to perform MIS for deformity. For L1–4, the surgeons preferred lateral approaches to TLIF and reserved ACR for patients who needed the greatest increase in segmental lordosis. For L4–5, the surgeons’ order of preference was LLIF, TLIF, and ALIF, but TLIF failed to demonstrate any significant lordosis restoration. At L5–S1, the surgical team typically preferred an ALIF when segmental lordosis was desired and preferred a TLIF if preoperative segmental lordosis was adequate.
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Elias, W. Jeffrey, Nathan E. Simmons, George J. Kaptain, James B. Chadduck, and Richard Whitehill. "Complications of posterior lumbar interbody fusion when using a titanium threaded cage device." Journal of Neurosurgery: Spine 93, no. 1 (July 2000): 45–52. http://dx.doi.org/10.3171/spi.2000.93.1.0045.
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Object. The authors reviewed their series of patients to quantify clinical and radiographic complications in those who underwent a posterior lumbar interbody fusion (PLIF) procedure in which a threaded interbody cage (TIC) was implanted. Methods. Sixty-seven patients underwent a posterior lumbar interbody fusion procedure in which a TIC was used. The authors excluded patients who underwent procedures in which other instrumentation was used or a nondorsal approach was performed. Fifteen percent of the cases (10 patients) were complicated by laceration of the dura. In three cases, bilateral implantation could not be performed. The average blood loss was 670 ml for all cases, and blood transfusion was required in 25% of the cases (17 patients). The rate of minor wound complication was 4.5% (three patients). One patient died. The average period of hospitalization was 4.25 days. Twenty-eight patients (42%) experienced significant low-back pain 3 months postoperatively, and in 10 (15%) of these cases it persisted beyond 1 year. In 10 patients postoperative radiculopathy was demonstrated, and magnetic resonance imaging revealed epidural fibrosis in six patients, arachnoiditis in one, and a recurrent disc herniation in one. One patient incurred a permanent motor deficit with sexual dysfunction. Pseudarthrosis was suggested radiographically with evidence of motion on lateral flexion—extension radiographs (10 cases), lucencies around the implants (seven cases), and posterior migration of the cage (two cases). Additional procedures (in 14 patients) consisted primarily of transverse process fusion with pedicle screw and plate augmentation for persistent back pain and radiographically demonstrated signs of spinal instability. In two patients with radiculopathy, migration of the TIC required that it be removed. Graft material that extruded from one implant necessitated its removal. In one patient scarectomy was performed. Conclusions. Our high incidence of TIC-related complications in PLIF is inconsistent with that reported in previous studies.
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Tani, Satoshi, Hiroyasu Nagashima, Akira Isoshima, Masahiko Akiyama, Hiroki Ohashi, Satoru Tochigi, and Toshiaki Abe. "A unique device, the disc space–fitted distraction device, for anterior cervical discectomy and fusion: early clinical and radiological evaluation." Journal of Neurosurgery: Spine 12, no. 4 (April 2010): 342–46. http://dx.doi.org/10.3171/2009.10.spine09283.
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Object To perform interbody distraction and to obtain spinal curvature correction during anterior cervical discectomy and fusion (ACDF), the authors recently adopted a new stand-alone device, a disc space–fitted distraction device (DFDD). In this preliminary report the authors introduce this unique device and discuss some advantages in terms of short-term clinical and radiological evaluations. Methods The most unique aspect of the DFDD is the function of gentle distraction at anterior disc space with maximum lordotic correction of up to 8° while rotating a screw at the front of the device. Additional advantages are related to its configuration such as disc space–matched shape in all dimensions, tapering contour for easy insertion into the disc space, multiple spikes to avoid dislodgment, wider contact area to the vertebral endplate for diminishing sinking process, and sufficient space for accommodation of bone-conductive materials. Twenty-four patients who have been observed more than 12 months after ACDF were involved in this evaluation. Results The objective clinical outcome, measured by the Neurological Cervical Spine Scale, was significantly improved. In radiological evaluation, statistically significant improvement compared with preoperative values was noted on the curvature index, C2–7 curvature, and disc angle (p < 0.01) throughout the entire postoperative period, up to 12 months. A high fusion rate and remodeling process around the implants were also observed. Conclusions The DFDD may have some advantages over other devices—its distraction action, diminished sinking, and early solid bone union resulted in maintaining sufficient correction of the spinal curvature. This corrected spinal curvature may play an important role in preventing progressive adjacent-disc degeneration subsequent to ACDF in the long term.
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Kok, D., M. Grevitt, FH Wapstra, and AG Veldhuizen. "The Memory Metal Spinal System in a Posterior Lumbar Interbody Fusion (PLIF) Procedure: A Prospective, Non-Comparative Study to Evaluate the Safety and Performance." Open Orthopaedics Journal 6, no. 1 (June 15, 2012): 220–25. http://dx.doi.org/10.2174/1874325001206010220.
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Study Design: A prospective, non-comparative study of 27 patients to evaluate the safety and performance of the Memory Metal Spinal System used in a PLIF procedure in the treatment of spondylolisthesis, symptomatic spinal stenosis or degenerative disc disease (DDD). Objective: To evaluate the clinical performance, radiological outcome and safety of the Memory Metal Spinal System, used in a PLIF procedure, in the treatment of spondylolisthesis, symptomatic spinal stenosis or degenerative disc disease in human subjects. Summary of Background Data: Spinal systems that are currently available for correction of spinal deformities or degeneration such as lumbar spondylosis or degenerative disc disease, use components manufactured from stainless steel or titanium and typically comprise two spinal rods with associated connection devices. The Memory Metal Spinal System consists of a single square spinal rod made from a nickel titanium alloy (Nitinol) used in conjunction with connection devices. Nitinol is characterized by its shape memory effect and is a more flexible material than either stainless steel or titanium. With current systems there is loss of achieved reposition due to the elastic properties of the spine. By using a memory metal in this new system the expectation was that this loss of reposition would be overcome due to the metal’s inherent shape memory properties. Furthermore, we expect a higher fusion rate because of the elastic properties of the memory metal. Methods: Twenty-seven subjects with primary diagnosis of spondylolisthesis, symptomatic spinal stenosis or degenerative disc disease (DDD) were treated with the Memory Metal Spinal System in conjunction with the Brantigan IF® Cage in two consecutive years. Clinical performance of the device was evaluated over 2 years using the Oswestry Disability Index (ODI), Short Form 36 questionnaire (SF-36) and pain visual analogue scale (VAS) scores. Safety was studied by collection of adverse events intra-operative and during the followup. Interbody fusion status was assessed using radiographs and a CT scan. Results: The mean pre-operative ODI score of 40.9 (±14.52) significantly improved to 17.7 (±16.76) at 24 months postoperative. Significant improvement in the physical component from the SF36 questionnaire was observed with increases from the baseline result of 42.4 to 72.7 at 24 months (p<.0001); The emotional component in the SF36 questionnaires mean scores highlighted a borderline significant increase from 56.5 to 81.7 at 24 months (p=0.0441). The average level of leg pain was reduced by more than 50% postoperation (VAS values reduced from 5.7 (±2.45) to 2.2 (±2.76) at 24 month post-operation with similar results observed for back pain. CT indicated interbody fusion rate was not significantly faster compared to other devices in literature. No device related adverse events were recorded in this study. Conclusions: The Memory Metal Spinal System, different from other devices on the market with regard to material and the one rod configuration, is safe and performed very well by improving clinically important outcomes in the treatment of spondylolisthesis, symptomatic spinal stenosis or degenerative disc disease. In addition the data compares favorably to that previously reported for other devices in the literature.
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Wang, Timothy Y., Vikram A. Mehta, Eric W. Sankey, Christopher I. Shaffrey, Muhammad M. Abd-El-Barr, and Khoi D. Than. "The Impact of Instrumentation and Implant Surface Technology on Cervical and Thoracolumbar Fusion." Operative Neurosurgery 21, Supplement_1 (June 15, 2021): S12—S22. http://dx.doi.org/10.1093/ons/opaa321.
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Abstract Spinal fusion has undergone significant evolution and improvement over the past 50 yr. Historically, spine fusion was noninstrumented and arthrodesis was based entirely on autograft. Improved understanding of spinal anatomy and materials science ushered in a new era of spinal fusion equipped with screw-based technologies and various interbody devices. Osteobiologics is another important realm of spine fusion, and the evolution of various osteobiologics has perhaps undergone the most change within the past 20 yr. A new element to spinal instrumentation has recently gained traction—namely, surface technology. New data suggest that surface treatments play an increasingly well-recognized role in inducing osteogenesis and successful fusion. Until now, however, there has yet to be a unified resource summarizing the existing data and a lack of consensus exists on superior technology. Here, authors provide an in-depth review on surface technology and its impact on spinal arthrodesis.
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Rauzzino, Michael J., Christopher I. Shaffrey, Russ P. Nockels, Gregory C. Wiggins, Jack Rock, and James Wagner. "Anterior lumbar fusion with titanium threaded and mesh interbody cages." Neurosurgical Focus 7, no. 6 (December 1999): E9. http://dx.doi.org/10.3171/foc.1999.7.6.10.
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The authors report their experience with 42 patients in whom anterior lumbar fusion was performed using titanium cages as a versatile adjunct to treat a wide variety of spinal deformity and pathological conditions. These conditions included congenital, degenerative, iatrogenic, infectious, traumatic, and malignant disorders of the thoracolumbar spine. Fusion rates and complications are compared with data previously reported in the literature. Between July 1996 and July 1999 the senior authors (C.I.S., R.P.N., and M.J.R.) treated 42 patients by means of a transabdominal extraperitoneal (13 cases) or an anterolateral extraperitoneal approach (29 cases), 51 vertebral levels were fused using titanium cages packed with autologous bone. All vertebrectomies (27 cases) were reconstructed using a Miami Moss titanium mesh cage and Kaneda instrumentation. Interbody fusion (15 cases) was performed with either the BAK titanium threaded interbody cage (in 13 patients) or a Miami Moss titanium mesh cage (in two patients). The average follow-up period was 14.3 months. Seventeen patients had sustained a thoracolumbar burst fracture, 12 patients presented with degenerative spinal disorders, six with metastatic tumor, four with spinal deformity (one congenital and three iatrogenic), and three patients presented with spinal infections. In five patients anterior lumbar interbody fusion (ALIF) was supplemented with posterior segmental fixation at the time of the initial procedure. Of the 51 vertebral levels treated, solid arthrodesis was achieved in 49, a 96% fusion rate. One case of pseudarthrosis occurred in the group treated with BAK cages; the diagnosis was made based on the patient's continued mechanical back pain after undergoing L4–5 ALIF. The patient was treated with supplemental posterior fixation, and successful fusion occurred uneventfully with resolution of her back pain. In the group in which vertebrectomy was performed there was one case of fusion failure in a patient with metastatic breast cancer who had undergone an L-3 corpectomy with placement of a mesh cage. Although her back pain was immediately resolved, she died of systemic disease 3 months after surgery and before fusion could occur. Complications related to the anterior approach included two vascular injuries (two left common iliac vein lacerations); one injury to the sympathetic plexus; one case of superficial phlebitis; two cases of prolonged ileus (greater than 48 hours postoperatively); one anterior femoral cutaneous nerve palsy; and one superficial wound infection. No deaths were directly related to the surgical procedure. There were no cases of dural laceration and no nerve root injury. There were no cases of deep venous thrombosis, pulmonary embolus, retrograde ejaculation, abdominal hernia, bowel or ureteral injury, or deep wound infection. Fusion-related complications included an iliac crest hematoma and prolonged donor-site pain in one patient. There were no complications related to placement or migration of the cages, but there was one case of screw fracture of the Kaneda device that did not require revision. The authors conclude that anterior lumbar fusion performed using titanium interbody or mesh cages, packed with autologous bone, is an effective, safe method to achieve fusion in a wide variety of pathological conditions of the thoracolumbar spine. The fusion rate of 96% compares favorably with results reported in the literature. The complication rate mirrors the low morbidity rate associated with the anterior approach. A detailed study of clinical outcomes is in progress. Patient selection and strategies for avoiding complication are discussed.
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Godzik, Jakub, Corey T. Walker, Nicholas Theodore, Juan S. Uribe, Steven W. Chang, and Laura A. Snyder. "Minimally Invasive Transforaminal Interbody Fusion With Robotically Assisted Bilateral Pedicle Screw Fixation: 2-Dimensional Operative Video." Operative Neurosurgery 16, no. 3 (September 24, 2018): E86—E87. http://dx.doi.org/10.1093/ons/opy288.
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Abstract Minimally invasive surgery (MIS) techniques may enable faster patient recovery and reduce the incidence of postoperative infections. Image-guided approaches to spinal instrumentation and interbody fusion have gained popularity in MIS, reducing radiation exposure and improving screw placement accuracy. Use of a novel computed tomography (CT) navigation-based robotic arm provides for live image-guided surgery, with the potential for augmenting existing MIS approaches and improving the accuracy of instrumentation placement. We report on the surgical technique of MIS transforaminal lumbar interbody fusion (TLIF) performed with the assistance of a new robotic device (ExcelsiusGPS, Globus Medical Inc, Audubon, Pennsylvania) and intraoperative CT guidance in a patient with single-level lumbar spondylolisthesis. The patient gave written informed consent before treatment. Institutional review board approval was deemed unnecessary. The patient was positioned prone on the operating room table, and an intraoperative CT was obtained with stereotactic arrays placed bilaterally in the posterior superior iliac spine. Screw trajectories were planned using the ExcelsiusGPS software and placed percutaneously with the robotic arm without using a Kirschner wire. Interbody placement was performed via an expandable retractor after muscle dilation. Screw placement accuracy was determined with postoperative CT, which demonstrated good screw positioning without breach. The patient recovered well and was discharged home without complications. The combined use of the new robotic device and intraoperative CT enables accurate and safe fixation for the treatment of symptomatic lumbar spondylolisthesis. The operative video demonstrates the technical nuances of positioning, stereotactic marker placement, work flow, and screw placement. Used with permission from Barrow Neurological Institute, Phoenix, Arizona.
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Jang, Jee Soo, Sang Ho Lee, and Sang Rak Lim. "Guide device for percutaneous placement of translaminar facet screws after anterior lumbar interbody fusion." Journal of Neurosurgery: Spine 98, no. 1 (January 2003): 100–103. http://dx.doi.org/10.3171/spi.2003.98.1.0100.
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Because the degree of immediate stabilization provided by cage-assisted anterior lumbar interbody fusion (ALIF) has been shown by several studies to be inadequate, supplementary posterior fixation, such as that created by translaminar or transpedicle screw fixation, is necessary. In this study, the authors studied the ALIF-augmentation procedure in which a special guide device is used to place percutaneously translaminar facet screws in 18 patients with degenerative lumbar disease. The minimum follow-up period was 1 month (mean 6 months, range 1–13 months). Degenerative spondylolisthesis with foraminal stenosis was diagnosed in nine patients, associated degenerative disc disease alone or combined with foraminal stenosis in eight, and recurrent disc herniation in one. Following screw placement, computerized tomography scanning was conducted to evaluate the accuracy of the facet screw positioning. All screws were properly placed. No screw penetrated the spinal canal or injured the neural structures. Excellent or good clinical outcomes were demonstrated in all patients at the last follow up. The use of this guide device for post—ALIF percutaneous translaminar facet screw fixation represents a safe, accurate, and minimally invasive modality with which to achieve immediate solid fixation in the lumbar spine.
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Godzik, Jakub, George M. Mastorakos, Gautam Nayar, William D. Hunter, and Luis M. Tumialán. "Surgeon and staff radiation exposure in minimally invasive spinal surgery: prospective series using a personal dosimeter." Journal of Neurosurgery: Spine 32, no. 6 (June 2020): 817–23. http://dx.doi.org/10.3171/2019.11.spine19448.
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OBJECTIVEThe level of radiation awareness by surgeons and residents in spinal surgery does not match the ubiquity of fluoroscopy in operating rooms in the United States. The present method of monitoring radiation exposure may contribute to the current deficiency in radiation awareness. Current dosimeters involve a considerable lag from the time that the surgical team is exposed to radiation to the time that they are provided with that exposure data. The objective of the current study was to assess the feasibility of monitoring radiation exposure in operating room personnel during lateral transpsoas lumbar interbody fusion (LLIF) and minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) procedures by using a wearable personal device with real-time feedback.METHODSOperating room staff participating in minimally invasive surgical procedures under a single surgeon during a 6-month period were prospectively enrolled in this study. All radiation dose exposures were recorded for each member of the surgical team (surgeon, assistant surgeon, scrub nurse, and circulating nurse) using a personal dosimeter (DoseAware). Radiation doses were recorded in microsieverts (μSv). Comparisons between groups were made using ANOVA with the Tukey post hoc test and Student t-test.RESULTSThirty-nine patients underwent interbody fusions: 25 underwent LLIF procedures (14 LLIF alone, 11 LLIF with percutaneous screw placement [PSP]) and 14 underwent MI-TLIF. For each operative scenario per spinal level, the surgeon experienced significantly higher (p < 0.035) average radiation exposure (LLIF: 167.9 μSv, LLIF+PSP: 424.2 μSv, MI-TLIF: 397.9 μSv) than other members of the team, followed by the assistant surgeon (LLIF: 149.7 μSv, LLIF+PSP: 242.3 μSv, MI-TLIF: 274.9 μSv). The scrub nurse (LLIF: 15.4 μSv, LLIF+PSP: 125.7 μSv, MI-TLIF: 183.0 μSv) and circulating nurse (LLIF: 1.2 μSv, LLIF+PSP: 9.2 μSv, MI-TLIF: 102.3 μSv) experienced significantly lower exposures. Radiation exposure was not correlated with the patient’s body mass index (p ≥ 0.233); however, it was positively correlated with increasing patient age (p ≤ 0.004).CONCLUSIONSReal-time monitoring of radiation exposure is currently feasible and shortens the time between exposure and the availability of information regarding that exposure. A shortened feedback loop that offers more reliable and immediate data would conceivably raise the level of concern for radiation exposure in spinal surgeries and could alter patterns of behavior, leading to decreased exposures. Further studies are ongoing to determine the effect of real-time dosimetry in spinal surgery.
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Sekhon, Lali H. S., William Sears, and Neil Duggal. "Cervical arthroplasty after previous surgery: results of treating 24 discs in 15 patients." Journal of Neurosurgery: Spine 3, no. 5 (November 2005): 335–41. http://dx.doi.org/10.3171/spi.2005.3.5.0335.
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Object. The potential role of cervical arthroplasty in patients who have undergone previous cervical surgery is unknown. The authors performed a prospective study involving nonrandomized clinical and radiological assessment in patients who had undergone either previous posterior cervical foraminotomy or anterior interbody fusion and who suffered new or persistent arm/neck symptoms related to neural compression. Methods. During a 30-month period, 15 patients who had previously undergone cervical spinal surgery underwent cervical arthroplasty that involved placement of the Bryan disc for neck or arm symptoms related to cervical disc disease. A total of 24 devices were implanted. Six of the 15 patients had undergone a previous posterior foraminotomy, and in nine cases an anterior interbody fusion had been perfomed at some stage prior to surgery. Clinical and radiological evaluations were performed preoperatively and after surgery to assess outcomes. A total of 24 arthroplasties were performed encompassing between one and three levels. There were no major perioperative complications or immediate device-related failures. Two patients were lost to follow up. The follow-up period ranged from 12 to 43 months (mean 24.2 ± 10.5 months). Good results were obtained in all cases as reflected by an increase in the visual analog scale score of 6.4 in terms of neck/arm pain (p < 0.05). There was no difference in Oswestry Disability Index scores for neck pain (p > 0.05) and no patient required surgery at the same level. In one patient hypermobility developed with internal subluxation of the device, which suggested a compromise adjacent to a two-level fusion at 21 months. The segment was hypermobile preoperatively. The patient has experienced recurrent neck pain but otherwise remains clinically well and has not required revision surgery to date. Conclusions. Insertion of the Bryan artificial cervical disc in patients who have previously undergone cervical fusion or posterior foraminotomy, in general, appears to be safe. It provided encouraging early clinical results, although patients with preoperative hypermobility should be treated with caution. Issues such as accelerated device-related wear and the use of arthroplasty after aggressive facetectomy resection will need further study; however, in carefully selected patients who have undergone previous surgery cervical arthroplasty may provide an additional tool in the management of cervical disc disease.
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Gupta, Ashish Kumar, Jitendra Singh Rathore, Lokpal Singh Bhati, Devendra Singh Rathore, and R. C. Meena. "Functional and radiological comparison of transforaminal lumbar interbody fusion method with interbody fusion device versus stand-alone bone graft in lumbar canal stenosis or degenerative lumbar instability." International Journal of Research in Orthopaedics 7, no. 2 (February 23, 2021): 291. http://dx.doi.org/10.18203/issn.2455-4510.intjresorthop20210195.
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<p><strong>Background: </strong>Spinal stability is the vertebral ability to maintain their relationship and limit their relative displacements during physiologic postures and loads.</p><p><strong>Methods:</strong> Hospital based prospective randomized comparative study design between 2 groups included patients of both sex attending SMS hospital Jaipur, from April 2018 to June 2019 or till sample size was achieved, with due permission from institutional ethical committee and review board and after taking written informed consent from patients.</p><p><strong>Results: </strong>Inter group comparison of VAS score showed same results in both groups which showed statistically non-significant results. VAS score showed significantly reduction in both group A and B till the study period. Inter group comparison of ODI score showed same results in both groups which showed statistically non-significant results. ODI score showed significantly reduction in both group A and B till the study period. Inter group comparison of fusion rate score showed same results in both groups which showed statistically non-significant results. Fusion rate score showed significantly increased in both group A and B till the study period and at the 12 month it was 100% fusion rate.</p><p><strong>Conclusions: </strong>In the current series, the TLIF procedure with local bone graft alone improved anterior vertebral translation, disc height, and lumbar lordosis. A proper surgical technique with adequate discectomy and facetectomy would contribute greatly to the improvement of the radiological parameters; however, this improvement was not maintained at the latest follow up.</p><p><strong> </strong></p>
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Elmekaty, Mohamed, Emad ElMehy, Peter Försth, Anna MacDowall, Ahmed El Elemi, Mohamed Hosni, and Yohan Robinson. "Safety of a novel modular cage for transforaminal lumbar interbody fusion − clinical cohort study in 20 patients with degenerative disc disease." SICOT-J 4 (2018): 24. http://dx.doi.org/10.1051/sicotj/2018019.
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Introduction: Transforaminal lumbar interbody fusion (TLIF) is used to reconstruct disc height and reduce degenerative deformity in spinal fusion. Patients with osteoporosis are at high risk of TLIF cage subsidence; possibly due to the relatively small footprint compared to anterior interbody devices. Recently, modular TLIF cage with an integral rail and slot system was developed to reduce cage subsidence and allow early rehabilitation. Objective: To study the safety of a modular TLIF device in patients with degenerative disc disorders (DDD) with regard to surgical complications, non-union, and subsidence. Methods: Patients with DDD treated with a modular TLIF cage (Polyetheretherketone (PEEK), VTI interfuse S) were analysed retrospectively with one-year follow-up. Lumbar sagittal parameters were collected preoperatively, postoperatively and at one year follow-up. Cage subsidence, fusion rate, screw loosening and proportion of endplate coverage were assessed in computed tomography scan. Results: 20 patients (age 66 ± 10 years, 65% female, BMI 28 ± 5 kg/m2) with a total of 37 fusion levels were included. 15 patients had degenerative spondylosis and 5 patients had degenerative scoliosis. The cages covered >60% of the vertebral body diameters. Lumbar lordosis angle and segmental disc angle increased from 45.2 ± 14.5 and 7.3 ± 3.6 to 52.7 ± 9.1 and 10.5 ± 3.5 (p = 0.029 and 0.0002) postoperatively for each parameter respectively without loss of correction at one year follow up. One case of deep postoperative infection occurred (5%). No cage subsidence occurred. No non-union or screw loosening occurred. Conclusions: The modular TLIF cage was safe with regard to subsidence and union-rate. It restored and maintained lumbar lordosis angle, segmental disc angle and disc height, which can be attributed to the large footprint of this modular cage.
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Salame, Khalil, Georges E. R. Ouaknine, Nissim Razon, and Semion Rochkind. "The use of carbon fiber cages in anterior cervical interbody fusion." Neurosurgical Focus 12, no. 1 (January 2002): 1–5. http://dx.doi.org/10.3171/foc.2002.12.1.2.
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Object Cage devices were introduced in spinal fusion to overcome the shortcomings of autograft, allograft, and biocompatible implants. The aim of this study was to assess the short-term results of anterior cervical discectomy and fusion (ACDF) in which an interbody carbon fiber cage (CFC) and local osteophyte–derived bone graft were implanted. Methods A retrospective review was conducted of 100 consecutive patients treated by ACDF in which a CFC was packed with bone fragments obtained from osteophytes at the surgical site. Plain radiographs with dynamic lateral views obtained 1 year postoperatively were used to assess bone fusion, alignment of the cervical spine, and stability. Dynamic radiographs were also obtained at last follow up to determine whether loss of cervical alignment or collapse at the fused disc had occurred. The mean follow-up period was 25 months. In all cases the cervical lordosis was maintained or corrected to different extents and disc height was restored. Solid fusion was achieved in 98% of the cases. There were no cage-related complications and no cases of cage failure. Conclusions The authors conclude that application of the CFC for ACDF is safe, effective, and technically feasible. Osteophytes resected during surgery may be a good alternative material for bone grafting in cage-assisted cervical interbody fusion.
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Gornet, Matthew F., J. Kenneth Burkus, Randall F. Dryer, John H. Peloza, Francine W. Schranck, and Anne G. Copay. "Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes for patients in the Maverick disc investigational device exemption study." Journal of Neurosurgery: Spine 31, no. 3 (September 2019): 347–56. http://dx.doi.org/10.3171/2019.2.spine181037.
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OBJECTIVEDespite evidence of its safety and effectiveness, the use of lumbar disc arthroplasty has been slow to expand due in part to concerns about late complications and the risks of revision surgery associated with early devices. More recently, FDA approval of newer devices and improving reimbursements have reversed this trend in the United States. Additional long-term data on lumbar disc arthroplasty are still needed. This study reports the 5-year results of the FDA investigational device exemption clinical trial of the Medtronic Spinal and Biologics’ Maverick total disc replacement.METHODSPatients with single-level degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational sites. In the period from April 2003 to August 2004, 405 patients received the investigational device and 172 patients underwent the control procedure of anterior lumbar interbody fusion. Outcome measures included the Oswestry Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the SF-36, disc height, interbody motion, heterotopic ossification (investigational device), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all of the following criteria were met: 1) ODI score improvement ≥ 15 points over the preoperative score; 2) maintenance or improvement in neurological status compared with preoperatively; 3) disc height success, that is, no more than a 2-mm reduction in anterior or posterior height; 4) no serious AEs caused by the implant or by the implant and the surgical procedure; and 5) no additional surgery classified as a failure.RESULTSCompared to that in the control group, improvement in the investigational group was statistically greater according to the ODI and SF-36 Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic ossification increased over time: 1.0% (4/382) at 1 year, 2.6% (9/345) at 2 years, and 5.9% (11/187) at 5 years. Investigational patients had fewer device-related AEs and serious device-related AEs than the control patients at both 2 and 5 years postoperatively. Noninferiority of the composite measure overall success was demonstrated at all follow-up intervals; superiority was demonstrated at 1 and 2 years.CONCLUSIONSLumbar disc arthroplasty is a safe and effective treatment for single-level lumbar degenerative disc disease, resulting in improved physical function and reduced pain up to 5 years after surgery.Clinical trial registration no.: NCT00635843 (clinicaltrials.gov)
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Le, Minh-Thai, Ching-Chi Hsu, and Kao-Shang Shih. "EVALUATION OF VARIOUS DEVICE DESIGNS FOR POSTERIOR LUMBAR INTERBODY FUSION SURGERY USING A T10–S1 MULTILEVEL SPINE MODEL." Biomedical Engineering: Applications, Basis and Communications 30, no. 01 (February 2018): 1850003. http://dx.doi.org/10.4015/s1016237218500035.
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A spinal fusion surgery has been the gold standard treatment for treating lumbar degenerative disc disease. Many clinical studies have demonstrated that adjacent segment degeneration was observed in patients over time. Different types of stabilization systems have been investigated using numerical approaches. However, numerical models developed in the past were simplified to reduce computational time. Additionally, it is quite difficult to compare different stabilization systems in clinical application due to variation in bone anatomy and density. The aim of this study is to evaluate and compare the biomechanical performances of different stabilization systems using a more realistic spine model. In this study, three-dimensional finite element models of the intact, injured and treated T10–S1 multilevel spines are developed. The intersegmental rotation, the maximum disc stress and the maximum implant stress are calculated. The results showed that the pedicle screw–rod system can provide better fixation stability and lower implant stress. The Coflex system (CFS) has an advantage on reducing the risk of adjacent segment degeneration. This study could provide useful information to surgeons understanding the effects of different stabilization systems on the biomechanical performances for the posterior lumbar interbody fusion surgery.
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Wang, Michael Y., and Charles Y. Liu. "Resorbable Polylactic Acid Interbody Spacers with Vertebral Autograft for Anterior Cervical Discectomy and Fusion." Neurosurgery 57, no. 1 (July 1, 2005): 135–40. http://dx.doi.org/10.1227/01.neu.0000163427.42536.a7.
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Abstract OBJECTIVE: Resorbable polylactic acid spinal implants have recently become commercially available. These spacers carry the advantages of allowing for clear visualization of new bone growth, eliminating the risk of pathogen transmission, and providing for consistent biomechanical quality. However, previously published reports on the use of these spacers have all utilized bone morphogenetic proteins to supplement the fusion. This report describes our early experience with the use of these devices for interbody reconstruction in anterior cervical discectomy with fusion. METHODS: Twenty patients underwent an anterior cervical discectomy with fusion at 30 levels during an 18-month period. All patients were implanted with polylactic acid interbody spacers using the Smith-Robinson technique. Supplementary anterior cervical plating was applied using unicortical semiconstrained screws, and the spacers were filled with vertebral endplate autograft bone shavings. Seven of the patients were smokers, and three were diabetics. Radiographic fusion was determined with dynamic cervical spine x-rays, and clinical responses were determined using the Medical Outcomes Study Short-Form 36-Item Health Survey, Odom's criteria, Nurick scores, and functional outcome swallowing score dysphagia scores. Follow-up averaged 11.6 months. RESULTS: Of the 9 patients with myelopathy, all experienced clinical improvement, with the mean Nurick score improving from 2.7 to 1.3. Of the 14 patients who had radiculopathy, 9 had complete resolution of symptoms, 4 experienced some improvement, and 1 had no improvement. All 20 patients demonstrated radiographic fusion at last follow-up as demonstrated by bridging bone between the vertebral bodies and the absence of motion on dynamic x-rays. CONCLUSION: Resorbable polylactic acid interbody spacers are safe and effective for anterior cervical discectomy and fusion. Use of locally harvested vertebral endplate bone packed within the spacer is sufficient to promote fusion in anterior cervical discectomy with fusion.
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Tuttle, Jonathan, Ahmed Shakir, and Haroon Fiaz Choudhri. "Paramedian approach for transforaminal lumbar interbody fusion with unilateral pedicle screw fixation." Neurosurgical Focus 20, no. 3 (March 2006): 1–5. http://dx.doi.org/10.3171/foc.2006.20.3.6.
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✓ Lumbar fusion is a commonly performed procedure for a variety of pathological conditions, and it is frequently used in the treatment of degenerative lumbar instability that is refractory to medical management. Pedicle screws and interbody devices have been used for internal fixation to promote arthrodesis, prevent nonunion, and facilitate early mobilization. Recently, attempts have been made to reduce the morbidity associated with lumbar fusion by using a variety of minimally invasive techniques. Many minimally invasive lumbar fusion procedures require specialized retractors, implants, image guidance systems, or insertion instruments. Other minimally invasive techniques are primarily applied to an ideal patient population (thin, healthy, and with no previous surgery). The authors describe their experience with a paramedian approach for minimally invasive transforaminal lumbar interbody fusion (TLIF) with unilateral pedicle screw (PS) fixation. This procedure requires only standard implants, instruments, and retractors, with direct visualization for all aspects of the procedure. The authors describe encouraging early results in a challenging patient population in which there was a high incidence of obesity, medical comorbidities, and previous surgery at the same level. The paramedian approach for TLIF performed using unilateral lumbar PSs has yielded successful outcomes in this series of 47 patients, and further study of this technique may help define its role as a minimally invasive procedure for spinal fusion.
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Kanayama, Masahiro. "Sagittal plane correction in pedicle subtraction osteotomy using the Xia 3 SUK Direct Vertebral Rotation System." Journal of Neurosurgery: Spine 19, no. 4 (October 2013): 507–14. http://dx.doi.org/10.3171/2013.7.spine121162.
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The Xia 3 SUK Direct Vertebral Rotation (DVR) System was developed for performing the vertebral derotation maneuver in scoliosis surgery. The author applied this device to sagittal plane correction in pedicle subtraction osteotomy for adult spinal deformity. The surgical procedure included 1) preparing secure proximal and distal foundations for correction using mutisegmental pedicle screw-rod fixation (to avoid stress concentration to a specific screw-bone interface), 2) decancellating only the posterior two-thirds of the vertebral column, 3) providing supplemental interbody fusion above and below the osteotomy site (the anterior one-third of the vertebral column and interbody cages serve as an anterior column support and a pivot of correction), 4) closing the osteotomy by gradual approximation of SUK tubes secured to the proximal- and distal-most screw heads, and 5) connecting rods between the proximal and distal screw-rod constructs. Eight consecutive patients with fixed sagittal imbalance were treated using this surgical procedure. No patient required distal fixation points extending to the sacrum and/or pelvis. The sagittal plane correction was 43°. The mean anterior deviation of the C-7 plumb line was improved from 12.7 cm to 4.0 cm immediately after surgery, and it was 6.0 cm at the final follow-up. A pedicle subtraction osteotomy using the Xia 3 SUK DVR System ensures a safe and secure sagittal plane correction in adult spinal deformity.
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Landriel, Federico, Santiago Hem, and Claudio Yampolsky. "Lateral Transpsoas Approach for Lumbar Indirect Lateral Recess Decompression: 2-Dimensional Operative Video." Operative Neurosurgery 16, no. 3 (July 17, 2018): 391. http://dx.doi.org/10.1093/ons/opy156.
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Abstract Neurogenic claudication is a common symptom of lumbar spinal stenosis; its pathophysiology is thought to be ischemia of the nerve roots secondary to compression from surrounding structures. The stenosis of the lateral recesses and neuroforamen can cause these symptoms and its surgical treatment is decompression. The placement of interbody cages that restore the disc space height may indirectly decompress the neuroforamen and alleviate the nerve impingement symptoms. In case of concomitant low-grade spondylolisthesis, interbody devices might also reduce the slippage. We present a technical surgical video of a minimally invasive lateral transpsoas fusion, relying on indirect decompression to treat a patient with neurogenic claudication secondary to grade 1 spondylolisthesis. The patient signed a written consent to publish a video, recording, photograph, image, illustration, and/or information about him.
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Kandziora, Frank, Hermann Bail, Gerhard Schmidmaier, Georg Schollmeier, Matti Scholz, Christian Knispel, Timo Hiller, et al. "Bone morphogenetic protein—2 application by a poly(d,l-lactide)—coated interbody cage: in vivo results of a new carrier for growth factors." Journal of Neurosurgery: Spine 97, no. 1 (July 2002): 40–48. http://dx.doi.org/10.3171/spi.2002.97.1.0040.
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Object. Growth factors such as bone morphogenetic protein—2 (BMP-2) have been proven to promote spine fusion and to overcome the disadvantages of an autologous bone graft. The optimum method to deliver such growth factors remains a matter of discussion. The purpose of this study was to determine the safety and efficacy of a new poly(d,l-lactide) (PDLLA) carrier system for BMP-2 and to compare this carrier system with a collagen sponge carrier in a sheep cervical spine interbody fusion model. Methods. Thirty-two sheep underwent C3–4 discectomy and fusion: Group 1, titanium cage (eight animals); Group 2, titanium cage coated with a PDLLA carrier (eight animals); Group 3, titanium cage coated with a PDLLA carrier including BMP-2 (150 µg) (eight animals); and Group 4, titanium cage combined with a collagen sponge carrier including BMP-2 (150 µg) (eight animals). Blood samples, body weight, and temperature were assessed. Radiographs were obtained pre- and postoperatively and after 1, 2, 4, 8, and 12 weeks. At the same time points, disc space height, intervertebral angle, and lordosis angle were measured. After the sheep were killed 12 weeks postoperatively, flexion—extension radiography was performed to evaluate fusion sites. Quantitative computerized tomography scans were obtained to assess bone mineral density (BMD), bone mineral content (BMC), and bone callus volume (BCV). Biomechanical testing was performed in flexion, extension, axial rotation, and lateral bending. Stiffness, range of motion, neutral, and elastic zone were determined. Histomorphological and -morphometrical analyses were performed, and polychrome sequential labeling was used to determine the timeframe of new bone formation. There were no differences among the groups concerning blood counts, body weight, and temperature. Compared with the noncoated cages, all PDLLA-coated cages showed significantly higher values for BMD of the callus, as well as slightly higher values for BMC, BCV, and the bone volume/total volume ratio. In comparison with the cage-alone group, the BMP-2 groups showed significantly higher values for BMD and biomechanical stiffness. Histomorphological, -morphometrical, and polychrome sequential labeling analyses demonstrated greater progression of callus formation in the BMP-2 groups than in any other group. Compared with BMP-2 delivered using a collagen sponge carrier, BMP-2 application with a PDLLA carrier resulted in a higher BCV and a greater progression of interbody callus formation in the histomorphometrical analysis. Conclusions. The use of cervical spine interbody fusion cages coated with PDLLA as a delivery system for growth factors was effective. In this 12-week follow-up study, the PDLLA coating showed no adverse effects. The slight but not significant positive effect of the PDLLA carrier on interbody fusion might be a result of the degradation process of the biodegradable carrier. Compared with collagen sponge delivery of BMP-2, the PDLLA-coated interbody cages significantly increased the results of interbody bone matrix formation. In this new combination (implant + PDLLA + growth factor) the cage represents a “real fusion” cage, because it not only serves as a mechanical device for spinal fixation but also as a local drug delivery system.
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Moore, Jason, Narayan Yoganandan, Frank A. Pintar, Jason Lifshutz, and Dennis J. Maiman. "Tapered cages in anterior lumbar interbody fusion: biomechanics of segmental reactions." Journal of Neurosurgery: Spine 5, no. 4 (October 2006): 330–35. http://dx.doi.org/10.3171/spi.2006.5.4.330.
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Object The aim of this study was to determine the in vitro biomechanical responses of lumbar spinal segments after implantation of tapered cages. Methods Range of motion (ROM)– and stiffness-related data were determined in 10 human cadaveric T12–S1 columns subjected to flexion, extension, and lateral bending modes before and after anterior lumbar interbody fusion in which stand-alone LT-CAGE devices were used. The overall column showed no significant changes in ROM or stiffness. At the instrumented level, stiffness increased significantly (p < 0.05) in flexion and lateral bending modes. Indications of instability in extension were present, but these values were not statistically significant. There was no evidence of adjacent-level instability at any level in any mode, except for the segment superior to the fixation level in flexion; here there was a significant increase in ROM (p < 0.05) and a decrease in stiffness. Conclusions The anatomical conformity and bilateral placement of cages provide ample stability and rigidity at the treated level, comparable to that of other cage systems. Because hypermobility is traditionally related to early degenerative changes, the present results appear to suggest that cages do not significantly contribute to such alterations.
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Lippman, Caleb R., Michael Hajjar, Bret Abshire, George Martin, Robert W. Engelman, and David W. Cahill. "Cervical spine fusion with bioabsorbable cages." Neurosurgical Focus 16, no. 3 (March 2004): 1–10. http://dx.doi.org/10.3171/foc.2004.16.3.5.
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Object Although it improves rates of fusion in surgical arthrodesis, conventional spinal instrumentation is associated with several risks, including hardware extrusion that injures adjacent anatomical structures, and disuse osteopenia as a result of stress shielding. The long-term effects of indwelling spinal instrumentation, although incompletely documented, may be detrimental. One way to avoid such problems would be to use bioabsorbable implantation devices. In this pilot study, performed in 1998 and 1999, the authors evaluated the use of a bioabsorbable interbody fusion device in a goat cervical spine model. Methods Forty-two goats underwent two-level anterior cervical discectomy and fusion: eight received iliac crest autograft; 16 received a cage implant composed of 70:30 poly(L-lactide-co-D,L-lactide)/polyglycolic acid (70:30 PLDLLA/PGA) filled with either autograft or recombinant human bone morphogenetic protein–2 (rhBMP-2); and 18 received a cage implant composed of 85:15 PLDLLA/PGA filled with either autograft or rhBMP-2. Animals were killed at 3, 6, and 12 months postsurgery, and their cervical spines were evaluated histologically, radiographically, and physically for fusion. A primarily fibrous union was demonstrated in all animals killed at 3 months. At 6 months, bone trabeculae had become more prominent and the fibrous response less so in all cohorts. This occurred most frequently in the animals that underwent fusion with the 70:30 PLDLLA/PGA cages filled with rhBMP-2, in which 63% attained a histologically confirmed union that contained quantitatively more bone and less fibrous tissue than in the other cohorts; 63% of the unions in the aforementioned cohort were graded quantitatively as being stable. Conclusions In this study the authors have established that the 85:15 PLDLLA/PGA cages are absorbed too quickly to be functionally useful in this model. The 70:30 PLDLLA/PGA cages worked as well as tricortical autograft when filled with cancellous autograft, and better when filled with rhBMP-2. At 6- and 12-month follow-up review, the 70:30 PLDLLA/PGA cages had not yet begun to be absorbed. There was little if any inflammatory response to these cages at 6 months. Future studies should include biomechanical and microradiographic testing, and a longer follow-up period is necessary in this model to determine when the 70:30 PLDLLA/PGA cages are absorbed.
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RAMOS, GUILHERME ZANDAVALLI, EMILIANO VIALLE, RAFAEL LUIZ PINTO, CRISTIANO MENEZES, MAURÍCIO SANTOS GUSMÃO, NICOLAS GONZÁLEZ MASANÉS, ASDRUBAL FALAVIGNA, et al. "INFLUENCE OF THE MISDEF ALGORITHM ON THE THERAPEUTIC DECISION FOR VERTEBRAL DEFORMITY IN THE ADULT." Coluna/Columna 19, no. 2 (June 2020): 96–103. http://dx.doi.org/10.1590/s1808-185120201902222428.
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ABSTRACT Objective The therapeutic decision in cases of adult spinal deformity takes numerous factors into account with a consequent variability in treatment options. The objective is to compare the impact of the MISDEF (minimally invasive spine deformity) algorithm on therapeutic decisions in cases of adult spinal deformity. Methods Prospective radiographic analysis of 40 cases of adult deformity. The cases were sent, in two steps, to 20 Latin American surgeons who had to choose among six treatment options with and without the use of the MISDEF. Results For the conducts of decompression, decompression and short fusion, decompression and fusion with interbody device, and osteotomy with extension of fusion to the thoracic spine, no significant differences were found when comparing decisions made with and without MISDEF. For osteotomy, we observed a tendency for the number of surgeons choosing this conduct to increase when the decision is made with MISDEF. We observed that the number of surgeons who decided on conservative treatment decreased with the use of MISDEF (p <0.001). In cases with sagittal vertical axis <6 cm or pelvic tilt <25 ° or PI-LL (pelvic incidence minus lumbar lordosis) <10 ° or coronal curve <20 °, there was a decrease in the conservative treatment option and an increase in osteotomy with proximal extension of the fusion with the use of MISDEF. Conclusions There is a tendency to increase indications of osteotomy and decrease the conservative treatment option when making a decision with MISDEF. The use of the algorithm showed no significant impact on the therapeutic decision in severe cases of adult deformity. Level of Evidence II; Prospective comparative radiographic analysis.
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Matsukawa, Keitaro, and Yoshiyuki Yato. "Smart glasses display device for fluoroscopically guided minimally invasive spinal instrumentation surgery: a preliminary study." Journal of Neurosurgery: Spine 34, no. 1 (January 2021): 150–54. http://dx.doi.org/10.3171/2020.6.spine20644.
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OBJECTIVEMost surgeons are forced to turn their heads away from the surgical field to see various intraoperative support monitors. These movements may result in inconvenience to surgeons and lead to technical difficulties and potential errors. Wearable devices that can be attached to smart glasses or any glasses are novel visualization tools providing an alternative screen in front of the user’s eyes, allowing surgeons to keep their attention focused on the operative task without taking their eyes off the surgical field. The aim of the present study was to examine the feasibility of using glasses equipped with a wearable display device that transmits display monitor data during fluoroscopically guided minimally invasive spinal instrumentation surgery.METHODSIn this pilot prospective randomized study, 20 consecutively enrolled patients who underwent single-segment posterior lumbar interbody fusion (PLIF) at L5–S1 performed using the percutaneous pedicle screw technique were randomly divided into two groups, a group for which the surgeon used a wearable display device attached to regular glasses while performing surgery (smart glasses group) and a group for which the surgeon did not use such a device (nonglasses group). Real-time intraoperative fluoroscopic images were wirelessly transmitted to the display device attached to the surgeon’s glasses. The number of head turns performed by the surgeon to view the standard fluoroscopic monitor during procedures and the operative time, estimated blood loss, radiation exposure time, screw placement accuracy, and intraoperative complication rate were evaluated for comparison between the two groups.RESULTSThe number of surgeon head turns to view the fluoroscopic monitor in the smart glasses group was 0.10 ± 0.31 times, which was significantly fewer than the head turns in the nonglasses group (82.4 ± 32.5 times; p < 0.001). The operative and radiation exposure times in the smart glasses group were shorter than those in the nonglasses group (operative time 100.2 ± 10.4 vs 105.5 ± 14.6 minutes, radiation exposure time 38.6 ± 6.6 vs 41.8 ± 16.1 seconds, respectively), although the differences were not significant. Postoperative CT showed one screw perforation in the nonglasses group, and no intraoperative complications were observed in either group.CONCLUSIONSThis is, to the authors’ knowledge, the first report on the feasibility of using this wearable display device attached to glasses for fluoroscopically guided minimally invasive spinal instrumentation surgery. Smart glasses display devices such as this one may be a valid option to facilitate better concentration on operative tasks by improving ergonomic efficiency during surgery.
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Foley, Kevin T., Sanjay K. Gupta, Jeff R. Justis, and Michael C. Sherman. "Percutaneous pedicle screw fixation of the lumbar spine." Neurosurgical Focus 10, no. 4 (April 2001): 1–9. http://dx.doi.org/10.3171/foc.2001.10.4.11.
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Object Standard techniques for lumbar pedicle screw fixation involve open exposures and extensive muscle dissection. The purpose of this study was to report the initial clinical experience with a novel device for percutaneous posterior fixation of the lumbar spine. Methods An existing multiaxial lumbar pedicle screw system was modified so that screws could be placed percutaneously by using an extension sleeve that would allow for remote manipulation of the polyaxial screw heads and remote engagement of the screw locking mechanism. A unique rod insertion device was developed that linked to the screw extension sleeves, allowing for a precut, precontoured rod to be placed through a small stab wound. Because the insertion device relies on geometrical constraint of the rod pathway through the screw heads, rods can be placed in a standard submuscular position with minimal manipulation, essentially no muscle dissection, and without the need for direct visual feedback. Twelve patients (six men and six women who ranged in age from 23–68 years) underwent pedicle screw fixation in which the rod insertion device was used. Spondylolisthesis was present in 10 patients and nonunion of a prior interbody fusion was present in two. All patients underwent successful percutaneous fixation. Ten patients underwent single-level fusions (six at L5–S1, three at L4–5, and one at L2–3), and two underwent two-level fusions (one from L–3 to L–5 and the other from L–4 to S–1). The follow-up period ranged from 3 to 12 months (mean 6.8 months). Conclusions Although percutaneous lumbar pedicle screw placement has been described previously, longitudinal connector (rod or plate) insertion has been more problematic. The device used in this study allows for straightforward placement of lumbar pedicle screws and rods through percutaneous stab wounds. Paraspinous tissue trauma is minimized without compromising the quality of spinal fixation. Preliminary experience with this device has been promising.
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Foley, Kevin T., and Sanjay K. Gupta. "Percutaneous pedicle screw fixation of the lumbar spine: preliminary clinical results." Journal of Neurosurgery: Spine 97, no. 1 (July 2002): 7–12. http://dx.doi.org/10.3171/spi.2002.97.1.0007.
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Object. Standard techniques for pedicle screw fixation of the lumbar spine involve open exposures and extensive muscle dissection. The purpose of this study was to report the initial clinical experience with a novel device for percutaneous posterior fixation of the lumbar spine. Methods. An existing multiaxial lumbar pedicle screw system was modified to allow screws to be placed percutaneously by using an extension sleeve that permits remote manipulation of the polyaxial screw heads and remote engagement of the screw-locking mechanism. A unique rod-insertion device was developed that linked to the screw extension sleeves, allowing for a precut and -contoured rod to be placed through a small stab wound. Because the insertion device relies on the geometrical constraint of the rod pathway through the screw heads, minimal manipulation is required to place the rods in a standard submuscular position, there is essentially no muscle dissection, and the need for direct visual feedback is avoided. Twelve patients (six men and six women) who ranged in age from 23 to 68 years underwent pedicle screw fixation in which the rod-insertion device was used. Spondylolisthesis was present in 10 patients and osseous nonunion of a prior interbody fusion was present in two. All patients underwent successful percutaneous fixation. Ten patients underwent single-level fusions (six at L5—S1, three at L4–5, and one at L2–3), and two underwent two-level fusions (one from L3–5 and the other from L4—S1). The follow-up period ranged from 10 to 19 months (mean 13.8 months). Conclusions. Although percutaneous lumbar pedicle screw placement has been described previously, longitudinal connector (rod or plate) insertion has been more problematic. The device used in this study allows for straightforward placement of lumbar pedicle screws and rods through percutaneous stab wounds. Paraspinous tissue trauma is minimized without compromising the quality of spinal fixation. Preliminary experience involving the use of this device has been promising.
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Ramhmdani, Seba, Marc Comair, Camilo A. Molina, Daniel M. Sciubba, and Ali Bydon. "Coflex interspinous implant placement leading to synovial cyst development: case report." Journal of Neurosurgery: Spine 29, no. 3 (September 2018): 265–70. http://dx.doi.org/10.3171/2018.1.spine171360.
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Interspinous process devices (IPDs) have been developed as less-invasive alternatives to spinal fusion with the goal of decompressing the spinal canal and preserving segmental motion. IPD implantation is proposed to treat symptoms of lumbar spinal stenosis that improve during flexion. Recent indications of IPD include lumbar facet joint syndrome, which is seen in patients with mainly low-back pain. Long-term outcomes in this subset of patients are largely unknown. The authors present a previously unreported complication of coflex (IPD) placement: the development of a large compressive lumbar synovial cyst. A 64-year-old woman underwent IPD implantation (coflex) at L4–5 at an outside hospital for low-back pain that occasionally radiates to the right leg. Postoperatively, her back and right leg pain persisted and worsened. MRI was repeated and showed a new, large synovial cyst at the previously treated level, severely compressing the patient’s cauda equina. Four months later, she underwent removal of the interspinous process implant, bilateral laminectomy, facetectomy, synovial cyst resection, interbody fusion, and stabilization. At the 3-month follow-up, she reported significant back pain improvement with some residual leg pain. This case suggests that facet arthrosis may not be an appropriate indication for placement of coflex.
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Gushcha, A. O., S. V. Kolesov, Ekaterina N. Poltorako, D. A. Kolbovskiy, and A. I. Kaz’min. "Surgical treatment of multilevel lumbar vertebral canal stenosis using dynamic stabilization. Multicenter study." N.N. Priorov Journal of Traumatology and Orthopedics 24, no. 4 (December 15, 2017): 11–17. http://dx.doi.org/10.17816/vto201724411-17.
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Purpose: to compare the results of surgical treatment of patients with multilevel lumbar vertebral canal stenosis. Patients and methods. Prospective randomized multicenter study included 71 patients aged 41 - 79 years. In the 1st group of patients (n=38) a standard wide decompression of the spinal canal, transpedicular fixation of one clinically and roentgenologically significant spinal motion segment using rigid stabilization and interbody fusion was performed. In the 2nd group (n=33) microdecompression of the spinal canal, transpedicular fixation of one clinically and roentgenologically significant segment using the rods of nitinol transpedicular device. The results were assessed by the pain VAS, ODI and SF-36 questionnaires, roentgenologic, CT and MRI data. Results. Mean follow up made up 1.5 years, the maximum one - 3.0 years. Significant pain relief and im- provement in the quality of life as compared with the preoperative level was reported for both groups. No sig- nificant difference between the groups was observed. Functional roentgenograms showed within 5° (4.2 - 6.5°) preservation of motion in the stabilized segment only in patients from the 2nd group. Adjacent segment pathology in 12 months after operation was diagnosed only in 1 patient from the 1st group. Conclusion. Preliminary results allow considering the dynamic transpedicular fixation using nitinol rods as an effective surgical technique for the treatment of degenerative lumbar spine pathology.
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Lavelle, William F., Nathaniel R. Ordway, Ali Araghi, Rudolph A. Buckley, and Amir H. Fayyazi. "An in vitro study examining a novel suction curette device for lumbar discectomy compared with standard manual discectomy." Journal of Neurosurgery: Spine 26, no. 4 (April 2017): 454–58. http://dx.doi.org/10.3171/2016.9.spine16283.
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OBJECTIVE This purpose of this study was to objectively evaluate and assess the efficacy and efficiency of discectomy and endplate preparation during transforaminal lumbar interbody fusion (TLIF) using traditional manual instrumentation versus a novel suction discectomy curette. Transforaminal lumbar interbody fusion is the most widely used approach for lumbar arthrodesis, and its success depends on the ability to achieve fusion. Complete preparation of intervertebral disc space (removal of the nucleus, endplate cartilage, and margin of inner annulus) is the surgical goal. Performing an adequate discectomy requires numerous instrument passes, increasing surgical time and the risk of complications. METHODS Four experienced spinal surgeons performed transforaminal discectomies from T-12 to S-1 on 5 whole-body cadavers. Each level (n = 26) was randomly assigned to either a control group using traditional instruments (12 levels) or to a suction curette group (14 levels). The time required to perform the discectomy and the number of passes through the annulus were recorded. Motion segments were dissected and analyzed by digital photogrammetric analysis. The intervertebral disc and the discectomy cross-sectional areas were measured on both superior and inferior images of each dissected surgical level. Areas were divided into 4 quadrants based on a midsagittal and midcoronal axis and analyzed for regional efficiency. In addition, a cross-sectional area of bony endplate (the area still covered with cartilage) and an area of endplate perforation were evaluated. RESULTS There was no significant difference in surgical time between the techniques (7:51 ± 2:43 minutes in the manual discectomy [MD] group and 7:06 ± 3:33 minutes in the suction curette discectomy [SD] group). There were significantly fewer (p < 0.01) instrument passes in the SD group (13 passes) compared with the MD group (43 passes). For both techniques, the amount of disc removed depended upon the anatomical region, with the posterior-contralateral side having the least amount of disc material removed. There was significantly less (p < 0.01) disc material removed in the MD group (38%) compared with the SD group (48%). The amount of disc material removed was significantly more (p < 0.05) in each quadrant when comparing the SD and MD groups, with the anterior regions showing the largest difference. For both techniques, the preparation of the endplate within the discectomy area resulted in a mostly cartilaginous interface (50% MD, 48% SD); a smaller amount of bony interface area (31% MD, 38% SD); and a smaller amount of perforation to the interface area (19% MD, 13% SD). There were no significant differences between the groups in terms of endplate preparation. CONCLUSIONS The improved discectomy observed with the suction curette device could potentially improve the clinical fusion rate.
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La Rosa, Giovanni, Antonino Germanò, Alfredo Conti, Fabio Cacciola, Gerardo Caruso, and Francesco Tomasello. "Posterior fusion and implantation of the SOCON-SRI system in the treatment of adult spondylolisthesis." Neurosurgical Focus 7, no. 6 (December 1999): E4. http://dx.doi.org/10.3171/foc.1999.7.6.5.
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Surgery for adult patients with lumbar and lumbosacral spondylolisthesis is reserved for those with intractable radiculopathy, claudication, or symptomatic spinal instability. Internal fixation, in which posterior fusion, transpedicular screw fixation, and implantation of titanium devices are performed, has been advocated to improve fusion rates and clinical results. Fourteen consecutive patients with Grade II to III lumbar and lumbosacral spondylolisthesis who underwent posterior decompression, reduction, autologous posterior facet joint arthrodesis, and SOCON-SRI implantation are retrospectively reviewed. All patients underwent complete preoperative clinical and neuroradiological evaluation. Treatment consisted of posterior decompressive surgery and implantation of the SOCON-SRI system (transpedicular screws, prebent longitudinal rods, and one locking-screw clamps). Distraction of the interbody space and rotation were performed to achieve an optimum spinal realignment. The facet joints were fused by using autologous bone graft. The authors obtained detailed clinical, functional, economic, and neuroradiological follow-up data for up to 14 months (range 8–18 months). The efficacy of the treatment was evaluated by comparing pre- and postoperative data. Pain was decreased in all cases, neurological dysfunction ameliorated in 50%, and functional and economic status was improved in 78% and 100%, respectively. No cases of fusion failure or instrumentation-related complications occurred. The authors describe their results of treating patients with spondylolisthesis in the light of the rationale for surgery and the more recent pertinent literature.
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Robbins, Matthew M., Alexander R. Vaccaro, and Luke Madigan. "The use of bioabsorbable implants in spine surgery." Neurosurgical Focus 16, no. 3 (March 2004): 1–7. http://dx.doi.org/10.3171/foc.2004.16.3.2.
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The use of bioabsorbable implants in spine surgery is expanding at a rapid pace. These implants are mimicking the roles of traditional metallic devices and are demonstrating similar efficacy in terms of maintaining stability and acting as carriers for grafting substances. Biomechanical studies have demonstrated their ability to stabilize effectively a degenerative cervical and lumbar motion segment. In numerous animal models, researchers have illustrated the ability of bioabsorbable implants to function satisfactorily as an interbody spacer and to achieve satisfactory bone fusion. Investigators have explored various opportunities for these implants to replace their metallic counterparts in clinical studies conducted in humans. The gradual resorption of these implants appears effectively to transfer gradual loads to the grafting substances promoting the biological mechanisms of fusion. Novel uses of bioabsorbable technology are constantly evolving. Their future as a carrier of biological agents such as bone morphogenetic proteins and bone graft extenders, their radiolucency, and their eventual resorption make them an ideal implant for use in spinal degenerative disease.
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Benglis, David, Michael Y. Wang, and Allan D. Levi. "A Comprehensive Review of the Safety Profile of Bone Morphogenetic Protein in Spine Surgery." Operative Neurosurgery 62, suppl_5 (May 1, 2008): ONS423—ONS431. http://dx.doi.org/10.1227/01.neu.0000326030.24220.d8.
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Abstract WE REVIEW OUR current understanding of the development and potential clinical applications of bone morphogenetic protein (BMP) in spine surgery. We also review the evidence for adverse events associated with the use of BMP and suggest potential reasons for these events and means of complication avoidance. Bone morphogenetic protein 2 (rhBMP-2) is approved by the Food and Drug Administration for anterior lumbar interbody fusion; rhBMP-7, on the other hand, is approved for long bone defects and has received a humanitarian device exemption for revision posterolateral lumbar operations and recalcitrant long bone unions. Nevertheless, “off-label” use in various spinal procedures has been reported and is increasing in frequency. Specific guidelines for rhBMP-2 and rhBMP-7 use are lacking because of the limited availability of randomized controlled clinical trials and its diverse use in many spinal applications. Mechanisms of delivery, carrier type, graft position, surgical location, and variations in BMP concentration may differ from one surgery to the next. Adverse events linked to either rhBMP-2 or rhBMP-7 use include ectopic bone formation, bone resorption or remodeling at the graft site, hematoma, neck swelling, and painful seroma. Other potential theoretical concerns include carcinogenicity and teratogenic effects. In this review, we provide the reader with a historical perspective on BMP, current and past research to support its use in spinal procedures, and a critical analysis of the complications reported thus far.
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Agazzi, Siviero, Harry R. van Loveren, Creighton J. Trahan, and Wesley M. Johnson. "Refinement of interbody implant testing in goats: a surgical and morphometric rationale for selection of a cervical level." Journal of Neurosurgery: Spine 7, no. 5 (November 2007): 549–53. http://dx.doi.org/10.3171/spi-07/11/549.
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Object The authors provide a surgical description of the ventral approach to the cervical spine in a goat model and identify selection of the most appropriate level for testing interbody devices. These constructs are designed for implantation in humans during anterior cervical discectomy and fusion. Such description and guidelines for level selection have never been published in either the medical or veterinarian literature. Methods The study comprised three phases: surgical, anatomical, and morphometric. Six goats underwent ventral approaches and were later killed; their necks were dissected and the cervical spines were processed to obtain clean specimens of the vertebral bodies. Measurements were made at each level using a contact digitizer. Results The anterolateral bone spurs, called alar processes, and the increased thickness of the longus colli muscle are the surgically relevant characteristics in the goat. The morphometric analysis showed that C2–3 is the most suitable level for implantation of interbody devices. The vertebral endplates at the C2–3 level are relatively flat and parallel to each other, and are perpendicular to the spinal canal axis. More distally, the endplates adopt a more curved arrangement, and the endplate angle becomes significantly greater than 90°. The authors describe anatomical landmarks that are important to safely and effectively perform a ventral cervical spinal approach in the goat. Conclusions The authors' model identifies C2–3 as the most appropriate level for animal testing of cervical implants because of its similarity to human anatomy. Further study with rigorous biomechanical range of motion evaluation of each caprine cervical level is needed.
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Zygourakis, Corinna C., Caterina Y. Liu, Malla Keefe, Christopher Moriates, John Ratliff, R. Adams Dudley, Ralph Gonzales, Praveen V. Mummaneni, and Christopher P. Ames. "Analysis of National Rates, Cost, and Sources of Cost Variation in Adult Spinal Deformity." Neurosurgery 82, no. 3 (May 9, 2017): 378–87. http://dx.doi.org/10.1093/neuros/nyx218.
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Abstract BACKGROUND Several studies suggest significant variation in cost for spine surgery, but there has been little research in this area for spinal deformity. OBJECTIVE To determine the utilization, cost, and factors contributing to cost for spinal deformity surgery. METHODS The cohort comprised 55 599 adults who underwent spinal deformity fusion in the 2001 to 2013 National Inpatient Sample database. Patient variables included age, gender, insurance, median income of zip code, county population, severity of illness, mortality risk, number of comorbidities, length of stay, elective vs nonelective case. Hospital variables included bed size, wage index, hospital type (rural, urban nonteaching, urban teaching), and geographical region. The outcome was total hospital cost for deformity surgery. Statistics included univariate and multivariate regression analyses. RESULTS The number of spinal deformity cases increased from 1803 in 2001 (rate: 4.16 per 100 000 adults) to 6728 in 2013 (rate: 13.9 per 100 000). Utilization of interbody fusion devices increased steadily during this time period, while bone morphogenic protein usage peaked in 2010 and declined thereafter. The mean inflation-adjusted case cost rose from $32 671 to $43 433 over the same time period. Multivariate analyses showed the following patient factors were associated with cost: age, race, insurance, severity of illness, length of stay, and elective admission (P < .01). Hospitals in the western United States and those with higher wage indices or smaller bed sizes were significantly more expensive (P < .05). CONCLUSION The rate of adult spinal deformity surgery and the mean case cost increased from 2001 to 2013, exceeding the rate of inflation. Both patient and hospital factors are important contributors to cost variation for spinal deformity surgery.
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Zhou, Zhiyu, Fuxin Wei, Sheng Huang, Manman Gao, Haisheng Li, Hans Stødkilde-Jørgensen, Martin Lind, Cody Bünger, and Xuenong Zou. "In Vivo Magnetic Resonance Imaging Evaluation of Porous Tantalum Interbody Fusion Devices in a Porcine Spinal Arthrodesis Model." Spine 40, no. 19 (October 2015): 1471–78. http://dx.doi.org/10.1097/brs.0000000000001068.
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Goodwin, Matthew L., William Ryan Spiker, Darrel S. Brodke, and Brandon D. Lawrence. "Failure of facet replacement system with metal-on-metal bearing surface and subsequent discovery of cobalt allergy: report of 2 cases." Journal of Neurosurgery: Spine 29, no. 1 (July 2018): 81–84. http://dx.doi.org/10.3171/2017.10.spine17862.
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The aim of this study was to report on 2 patients in whom metal-on-metal (MOM) facet replacements failed, with subsequent positive findings on allergy testing. Motion-preserving devices have been used with limited success when instrumentation is indicated in the mobile spine. MOM-bearing surfaces in orthopedics were developed to increase implant longevity, yet have been associated with numerous adverse outcomes, including local tissue reactions, pseudotumors, metallosis, and the need for revision surgery. Five patients with spinal stenosis and low-grade spondylolisthesis were randomized to undergo facet replacement surgery with the ACADIA facet replacement system at the authors’ institution. Two patients experienced a return of neurological symptoms after a pain-free interval (< 2 years) with development of local tissue reaction and positive findings on allergy testing to cobalt, the metal in the MOM-bearing surface. Both patients underwent successful removal of the implant and revision to titanium posterior spinal fusion and interbody fusion without further complication.Motion-preserving devices have been designed and trialed for specific indications in the mobile spine. Given the adverse results from MOM devices in hip arthroplasty and now the early reports with MOM facet replacements, caution is warranted when moving forward with any MOM joint–bearing surface. Both patients presented here had an unusual tissue reaction locally and subsequent positive allergy testing results to cobalt. These 2 patients appear to have developed a delayed hypersensitivity reaction to the metal, likely from fine debris at the MOM interface.