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Carl Lauryssen,1 Sigurd Berven,2 Ronnie Mimran,3 Christopher Summa,4 Michael Sheinberg,5 Larry E Miller,6,7 Jon E Block71Tower Orthopedics, Beverly Hills, CA, USA; 2Department of Orthopedics, University of California, San Francisco, San Francisco, CA, USA; 3Pacific Brain and Spine, Castro Valley, CA, USA; 4The Spine Clinic of Monterey Bay, Soquel, CA, USA; 5Danville, CA, USA; 6Miller Scientific Consulting Inc, Arden, NC, USA; 7The Jon Block Group, San Francisco, CA, USABackground: Laminectomy/laminotomy and foraminotomy are well established surgical techniques for treatment of symptomatic lumbar spinal stenosis. However, these procedures have significant limitations, including limited access to lateral and foraminal compression and postoperative instability. The purpose of this cadaver study was to compare bone, ligament, and soft tissue morphology following lumbar decompression using a minimally invasive MicroBlade Shaver® instrument versus hemilaminotomy with foraminotomy (HL).Methods: The iO-Flex® system utilizes a flexible over-the-wire MicroBlade Shaver instrument designed for facet-sparing, minimally invasive “inside-out” decompression of the lumbar spine. Unilateral decompression was performed at 36 levels in nine human cadaver specimens, six with age-appropriate degenerative changes and three with radiographically confirmed multilevel stenosis. The iO-Flex system was utilized on alternating sides from L2/3 to L5/S1, and HL was performed on the opposite side at each level by the same investigator. Spinal canal, facet joint, lateral recess, and foraminal morphology were assessed using computed tomography.Results: Similar increases in soft tissue canal area and decreases in ligamentum flavum area were noted in nondiseased specimens, although HL required removal of 83% more laminar area (P < 0.01) and 95% more bone resection, including the pars interarticularis and facet joints (P < 0.001), compared with the iO-Flex system. Similar increases in lateral recess diameter were noted in nondiseased specimens using each procedure. In stenotic specimens, the increase in lateral recess diameter was significantly (P = 0.02) greater following use of the iO-Flex system (43%) versus HL (7%). The iO-Flex system resulted in greater facet joint preservation in nondiseased and stenotic specimens. In stenotic specimens, the iO-Flex system resulted in a significantly greater increase in foraminal width compared with HL (24% versus 4%, P = 0.01), with facet joint preservation.Conclusion: The iO-Flex system resulted in significantly better decompression of the lateral recess and foraminal areas compared with HL, while preserving posterior spinal elements, including the facet joint.Keywords: decompression, laminectomy, lumbar, minimally invasive, stenosis, MicroBlade Shaver, iO-Flex system

Background: The purpose of the present study was to determine the effectiveness of selective nerve-root injections in obviating the need for an operation in patients with lumbar radicular pain who were otherwise considered to be operative candidates. Although selective nerve-root injections are used widely, we are not aware of any prospective, randomized, controlled, double-blind studies demonstrating their efficacy.Methods: Fifty-five patients who were referred to four spine surgeons because of lumbar radicular pain and who had radiographic confirmation of nerve-root compression were prospectively randomized into the study. All of the patients had to have requested operative intervention and had to be considered operative candidates by the treating surgeon. They then were randomized and referred to a radiologist who performed a selective nerve-root injection with either bupivacaine alone or bupivacaine with betamethasone. The treating physicians and the patients were blinded to the medication. The patients were allowed to choose to receive as many as four injections. The treatment was considered to have failed if the patient proceeded to have the operation, which he or she could opt to do at any point in the study.Results: Twenty-nine of the fifty-five patients, all of whom had initially requested operative treatment, decided not to have the operation during the follow-up period (range, thirteen to twenty-eight months) after the nerve-root injections. Of the twenty-seven patients who had received bupivacaine alone, nine elected not to have the operation. Of the twenty-eight patients who had received bupivacaine and betamethasone, twenty decided not to have the operation. The difference in the operative rates between the two groups was highly significant (p < 0.004).Conclusions: Our data demonstrate that selective nerve-root injections of corticosteroids are significantly more effective than those of bupivacaine alone in obviating the need for a decompression for up to thirteen to twenty-eight months following the injections in operative candidates. This finding suggests that patients who have lumbar radicular pain at one or two levels should be considered for treatment with selective nerve-root injections of corticosteroids prior to being considered for operative intervention. [ABSTRACT FROM AUTHOR]

Background: Retrospective clinical studies frequently utilize surgeon records as a source of outcomes data. The accuracy of data derived from surgeon records, however, is unknown. The purpose of the present study was to evaluate the accuracy of surgeon records in documenting the prevalence of subjective adverse outcomes.Methods: Consecutive patients who had undergone anterior cervical arthrodesis by four spine surgeons during a ten-month period were included. Surgeon records from the routine six-week, three-month, and six-month postoperative visits were examined for documentation of persistent dysphagia and dysphonia. Patients completed surveys inquiring about the presence and magnitude of symptoms at these three time-points. Agreement between the surgeon records and the patient surveys was analyzed with use of the kappa coefficient.Results: One hundred and sixty-six patients had 342 postoperative visits. Dysphagia was documented twenty-six times in the surgeon records, compared with 107 times on the patient surveys. Dysphagia was thus underreported in 80% of cases. Similarly, dysphonia was documented ten times in the surgeon records, compared with seventy-two times on the patient surveys. Poor correlation between the surgeon records and the patient surveys was observed regardless of symptom severity, previous anterior cervical surgery, anterior arthrodesis of three motion segments or more, arthrodesis cephalad to the fifth cervical level, and anterior cervical plate use. Poor correlation between the surgeon records and the patient surveys also was observed for each surgeon, regardless of subspecialty or institution.Conclusions: Correlation between the surgeon records and the patient surveys was consistently poor, regardless of the specific patient and surgeon factor analyzed. While we chose to study dysphonia and dysphagia, it is conceivable that the results may be generalizable to many situations in which office notes are utilized to ascertain the prevalence of subjective adverse outcomes. These results suggest that the prevalence of such outcomes may be seriously underreported in studies that rely on the retrospective analysis of surgeon records. [ABSTRACT FROM AUTHOR]

The objective of this case report is to discuss the successful postoperative analgesic management in a patient who had disseminated rectal cancer pain and failed to obtain pain relief despite high-dose intravenous hydromorphone. A 45-year-old male had metastatic rectal cancer involving multiple vertebrae. After a T6 corpectomy, the patient failed to obtain effective pain relief with massive doses of parenteral opioids. The epidural catheter was placed under fluoroscopy. The patient subsequently failed to obtain relief with epidural administration of bupivacaine and hydromophone. Epidural sufentanil was used to obtain adequate pain control. Postoperative epidural analgesia is a technique worthy of consideration for patients with extreme opioid dependency for corpectomy. Epidural sufentanil can successfully be administered for postoperative pain control for patients receiving a large dose of opioids for cancer pain. [ABSTRACT FROM AUTHOR]

Recent reports have highlighted the unusual complication of distant cerebellar haemorrhage after supratentorial craniotomy, with only 25 previous cases reported in the literature. Nearly all reported cases occurred after craniotomy for temporal lobectomy or for deep seated intracerebral pathology requiring brain retraction and removal of CSF at surgery. Only one previous case of a cerebellar haemorrhage after evacuation of an extracerebral fluid collection has been reported. We describe the case of a cerebellar haemorrhage complicating the evacuation of an acute/subacute supratentorial subdural haematoma in a 83-year-old woman. The literature is reviewed and possible mechanisms of haemorrhage discussed. [ABSTRACT FROM AUTHOR]

Literature review, technique overview, prospective and retrospective data analysis. [ABSTRACT FROM AUTHOR]

STUDY DESIGN: A case report with repeated measures is presented. OBJECTIVE: To describe an objective method for evaluating changes in upper- and lower-extremity spasticity and strength, as well as temporal and kinematic gait variables, after surgical intervention for cervical spondylotic myelopathy. SUMMARY OF BACKGROUND DATA: Degenerative cervical spinal disease is a common disorder, with some form of spondylosis demonstrated radiographically in more than 80% of those older than 55 years. Normative pre- and postoperative objective data quantifying spasticity, strength, and gait do not exist. METHODS: A 65-year-old woman underwent C2-C3 anterior cervical discectomy and fusion for progressive myelopathy secondary to a spondylosis and disc herniation. The measure for spasticity and strength at the ankles and elbows and a gait analysis were collected before surgery and at 11 days, 3 and 6 months after surgery. Spasticity and strength were assessed using a dynamometer, and a six-camera video system was used to record the gait. RESULTS: Preoperative left elbow flexor spasticity was more than 10 times greater than the values for the able bodies. It was reduced to normal levels after surgery. Substantial presurgery weakness was present in the elbow flexors and extensors bilaterally. Elbow extensor strength was at able-body levels after surgery. Gait speed was 57% of the able-body level before surgery and 78% of the able-body level 6 months after surgery. CONCLUSIONS: This case study demonstrated the role of biomechanics in characterizing impairments associated with cervical spondylosis and its surgical intervention. Measures for spasticity, strength, and gait taken before and after surgery indicated a favorable outcome. This report provides a foundation for the continued use of biomechanical methods to measure changes in function and impairments associated with surgical intervention of cervical spine disorders. [ABSTRACT FROM AUTHOR]

Background Context: Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months., Purpose: To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years., Study Design: Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial., Patient Sample: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls., Outcome Measures: The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments., Methods: Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score., Results: At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both)., Conclusions: Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes., Competing Interests: Declaration of competing interest One or more of the authors declare financial or professional relationships on ICMJE-TSJ disclosure forms., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Patients may occasionally have persistent or recurrent radicular symptoms after cervical artificial disc replacement (ADR) for cervical spondylotic radiculopathy. We describe our approach using anterior cervical foraminotomy (ACF) to provide symptom relief in such patients without the need to convert to a fusion or remove the ADR implant., Methods: Our operative technique for ACF after cervical ADR begins by starting at the lateral edge of the ADR at the superior end plate of the inferior vertebral body. The ipsilateral uncovertebral joint is drilled with a combination of a high-speed burr and diamond-coated burr to minimize the risk of injury to the vertebral artery. The neuroforamen is entered after drilling through the posterior aspect of the uncinate process. The exiting cervical nerve root should be directly visualized, and a Kerrison rongeur may be used to trace along the nerve root laterally to remove any remaining uncinate osteophyte or process. We queried our internal database for patients with recurrent or new radicular pain following cervical ADR who underwent ACF. Clinical characteristics and outcomes were reported., Results: Five patients with recurrent radicular symptoms after ADR were reviewed. Two ACFs were performed at C5-6, and 2 were performed at C6-7. Four patients developed ipsilateral recurrent radicular symptoms, and only 1 patient developed contralateral new radicular symptoms. Three patients reported complete resolution of their new or recurrent radicular symptoms following ACF, and 2 patients reported only partial resolution. No patients required conversion to a fusion., Conclusions: In patients with recurrent symptoms of cervical spondylotic radiculopathy following ADR, ACF with uncovertebral joint resection can be used to provide direct foraminal decompression without the need for implant removal. This approach also preserves motion at the affected level, preserves cervical spinal stability, and prevents the need for spinal fusion., Clinical Relevance: Patients with persistent or recurrent radicular symptoms after cervical ADR may achieve resolution of symptoms through a modified ACF technique., Competing Interests: Declaration of Conflicting Interests: Eli Baron (Eli.Baron@cshs.org): Royalties from Elsevier, McGraw Hill on 2 textbooks. Carl Lauryssen (clauryssen@gmail.com): Sea Spine (consultant and royalties), CTL (consultant and royalties), BK Spine (royalties). Jason M. Cuellar (Jason.Cuellar@cshs.org): Centinel Spine (consultant)., (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2022 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.)

Background Context: Various designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series., Purpose: To evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy., Study Design/setting: Prospective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial., Patient Sample: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF., Outcome Measures: Pain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months., Methods: Using propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls)., Results: Both ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups., Conclusions: M6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring. CONCLUSIONS Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy. Clinical trial registration no.: NCT00374413 (clinicaltrials.gov).

The surgical repair of atlantoaxial instabilities (AAI) presents complex and unique challenges, originating from abnormalities and/or trauma within the junction regions of the C1-C2 atlas-axis, to surgeons. When this region is destabilized, surgical fusion becomes of key importance in order to prevent spinal cord injury. Several techniques can be utilized to provide for the adequate fusion of the atlantoaxial construct. Nevertheless, many individuals have less than ideal rates of fusion, below 35%-40%, which also involves the C2 nerve root being sacrificed. This suboptimal and unavoidable iatrogenic complication results in the elevated probability of complications typically composed of vertebral artery injury. This review is a retrospective analysis of 87 patients from Cedars Sinai Medical Center in Los Angeles, California, who had the C1-C2 surgical fusion procedure performed within the time frame from 2001 to 2008, with a mean follow-up period of three years. These patients had presented with typical AAI symptoms of fatigability, limited mobility, and clumsiness. Diagnosis of C1-C2 instability was documented via radiographic studies, typically utilizing computed tomography (CT) scans or x-rays. All patients had bilateral C1 lateral masses and C2 pedicle screws. In addition, the C1-C2 joint was accessed by retracting the C2 nerve root superiorly and exposing the joint by utilizing a high-speed burr. The cavity that is developed within the joint is packed with local autologous bone from the cephalad resection of the C2 laminae. Fusion of the C1-C2 joint was achieved in all patients and a final follow-up was conducted approximately three years postoperative. Of the 87 patients, two presented with occipital headaches resulting from the C1 screws impinging on the C2 nerve root. The issue was rectified by removing instrumentation in both patients after documenting complete fusion via radiographic studies, with complete resolution of symptoms. No vertebral artery or spinal cord injuries were reported as a result of the minor complication. Overall, we aim to describe a safe and reliable alternative technique to fuse C1-C2 instability by focusing on intra-articular arthrodesis complementing instrumentation fixation. This methodology is advantageous from a biomechanical standpoint secondary to axial loading, as well as the large surface area available for arthrodesis. Additionally, this technique does not involve the resection of the C2 nerve root, resulting in low risk for vertebral artery or spinal cord injury., Competing Interests: The authors have declared that no competing interests exist.

Study Design: A retrospective, multicenter, medical record review and independent analysis of computed tomographic scans was performed in 46 patients to determine radiographic arthrodesis rates after 1-segment, 2-segment, or 3-segment instrumented posterolateral fusions (PLF) using autograft, bone marrow aspirate (BMA), and a nanocrystalline hydroxyapatite bone void filler (nHA)., Objective: To determine the radiographic arthrodesis rates after instrumented lumbar PLF using local autograft, BMA, and nHA., Summary of Background Data: The use of iliac crest autograft in posterolateral spine fusion carries real and significant risks. Many forms of nanocrystalline hydroxyapatite have been studied in various preclinical models, but no human studies have reviewed its efficacy as a bone graft supplement in PLF., Methods: Posterolateral arthrodesis progression was documented approximately 12 months postoperatively using a computed tomographic scan and evaluated by an independent radiologist for the presence of bridging bone. One-year postoperative clinical outcomes were assessed using the PROLO score., Results: Radiographically, 91% patients treated exhibited bilateral or unilateral posterolateral bridging bone. Ninety-four percent of the segments treated exhibited bilateral or unilateral posterolateral bridging bone, whereas 6% segments exhibited no posterolateral bridging bone on either side. A total of 93% individual sites treated exhibited posterolateral bridging bone. In 1-segment, 2-segment, and 3-segment arthrodesis, 88%, 93%, and 100%, respectively, of individual sites exhibited radiographic bridging bone. One-year postoperative PROLO scores for 77% patients were excellent or good. There were no complications related to the posterolateral graft mass and no symptomatic nonunions., Conclusions: The arthrodesis rates after instrumented lumbar fusion using local autograft mixed with BMA and the nHA is equivalent to the rates reported for iliac crest autograft in these indications, including stringent indications, such as 3-segment procedures. By approximately 12 months postoperatively, there was no significant difference in the rates of bridging bone between the 1-segment, 2-segment, and 3-segment procedures.

Study Design: Analysis of prospectively collected radiographic data., Objective: To investigate the influence of preoperative index-level range of motion (ROM) and disc height on postoperative ROM after cervical total disc arthroplasty (TDA) using compressible disc prostheses., Summary of Background Data: Clinical studies demonstrate benefits of motion preservation over fusion; however, questions remain unanswered as to which preoperative factors have the ability to identify patients who are most likely to have good postoperative motion, which is the primary rationale for TDA., Methods: We analyzed prospectively collected data from a single-arm, multicenter study with 2-year follow up of 30 patients with 48 implanted levels. All received compressible cervical disc prostheses of 6 mm-height (M6C, Spinal Kinetics, Sunnyvale, CA). The influence of index-level preoperative disc height and ROM (each with two levels: below-median and above-median) on postoperative ROM was analyzed using 2 x 2 ANOVA. We further analyzed the radiographic outcomes of a subset of discs with preoperative height less than 3 mm, the so-called "collapsed" discs., Results: Shorter (3.0 ± 0.4 mm) discs were significantly less mobile preoperatively than taller (4.4 ± 0.5 mm) discs (6.7° vs. 10.5°, P = 0.01). The postoperative ROM did not differ between the shorter and taller discs (5.6° vs. 5.0°, P = 0.63). Tall discs that were less mobile preoperatively had significantly smaller postoperative ROM than short discs with above-median preoperative mobility (P < 0.05). The "collapsed discs" (n = 8) were less mobile preoperatively compared with all discs combined (5.1° vs. 8.6°, P < 0.01). These discs were distracted to more than two times the preoperative height, from 2.6 to 5.7 mm, and had significantly greater postoperative ROM than all discs combined (7.6° vs. 5.3°, P < 0.05)., Conclusion: We observed a significant interaction between preoperative index-level disc height and ROM in influencing postoperative ROM. Although limited by small sample size, the results suggest discs with preoperative height less than 3 mm may be amenable to disc arthroplasty using compressible disc prostheses., Level of Evidence: 2.

Background: Traditional surgical options for the treatment of symptomatic lumbar spinal stenosis include decompression alone vs decompression and fusion; both options have potential limitations., Objective: To report the 36-month follow-up analysis of the coflex Interlaminar Stabilization (Paradigm Spine, LLC, New York, New York) after decompression, examined under a Food and Drug Administration investigational device exemption clinical trial, which is intended to provide stabilization after decompression while preserving normal segmental motion at the treated level., Methods: The coflex trial was a prospective, randomized investigational device exemption study conducted at 21 clinical sites in the United States. Baseline and follow-up visits collected demographics, clinical, and radiographic status. The primary endpoint was a measure of composite clinical success 24 months postoperatively. For this current 36-month analysis, composite clinical success was calculated using analogous methods., Results: Composite clinical success at 36 months was achieved by 62.2% among 196 coflex Interlaminar Stabilization patients and 48.9% among 94 fusion patients (difference = 13.3%, 95% confidence interval, 1.1%-25.5%, P = .03). Bayesian posterior probabilities for noninferiority (margin = -10%) and superiority of cofle Interlaminar Stabilization vs fusion were >0.999 and 0.984, respectively. Substantial and comparable improvements were observed in both groups for patient-reported outcomes, although the percentage with a clinically significant improvement (≥15) in the Oswestry Disability Index seemed larger for the coflex Interlaminar Stabilization group relative to the fusion group (P = .008). Radiographic measurements maintained index level and adjacent level range of motion in coflex Interlaminar Stabilization patients, although range of motion at the level superior to fusion was significantly increased (P = .005)., Conclusion: Coflex Interlaminar Stabilization for stenosis is proven to be effective and durable at improving overall composite clinical success without altering normal spinal kinematic motion at the index level of decompression or adjacent levels., Abbreviations: CCS, composite clinical successCEC, clinical events committeeFDA, Food and Drug AdministrationIDE, investigational device exemptionILS, Coflex Interlaminar StabilizationODI, Oswestry Disability IndexSF-12, Short-Form 12VAS, visual analogue scalesZCQ, Zurich Claudication Questionnaire.

Introduction: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device., Methods: This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex(®) Interlaminar Stabilization(®) device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery., Results: At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years., Conclusion: Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels., Level of Evidence and Ethical Statements: This is a Level I study. Institutional approval was received at each of the sites participating in the trial. Each patient gave informed consent to participate in the trial.

Background: Approved treatment modalities for the surgical management of lumbar spinal stenosis encompass a variety of direct and indirect methods of decompression, though all have varying degrees of limitations and morbidity which potentially limit the efficacy and durability of the treatment. The coflex(®) interlaminar stabilization implant (Paradigm Spine, New York, NY), examined under a United States Food and Drug Administration (US FDA) Investigational Device Exemption (IDE) clinical trial, is shown to have durable outcomes when compared to posterolateral fusion in the setting of post-decompression stabilization for stenotic patients. Other clinical and radiographic parameters, more indicative of durability, were also evaluated. The data collected from these parameters were used to expand the FDA composite clinical success (CCS) endpoint; thus, creating a more stringent Therapeutic Sustainability Endpoint (TSE). The TSE allows more precise calculation of the durability of interlaminar stabilization (ILS) when compared to the fusion control group., Methods: A retrospective analysis of data generated from a prospective, randomized, level-1 trial that was conducted at 21 US sites was carried out. Three hundred forty-four per-protocol subjects were enrolled and randomized to ILS or fusion after decompression for lumbar stenosis with up to grade 1 degenerative spondylolisthesis. Clinical, safety, and radiographic data were collected and analyzed in both groups. Four-year outcomes were assessed, and the TSE was calculated for both cohorts. The clinical and radiographic factors thought to be associated with therapeutic sustainability were added to the CCS endpoints which were used for premarket approval (PMA)., Results: Success rate, comprised of no second intervention and an ODI improvement of ≥ 15 points, was 57.6% of ILS and 46.7% of fusion patients (p = 0.095). Adding lack of fusion in the ILS cohort and successful fusion in the fusion cohort showed a CCS of 42.7% and 33.3%, respectively. Finally, adding adjacent level success to both cohorts and maintenance of foraminal height in the coflex cohort showed a CCS of 36.6% and 25.6%, respectively. With additional follow-up to five years in the U.S. PMA study, these trends are expected to continue to show the superior therapeutic sustainability of ILS compared to posterolateral fusion after decompression for spinal stenosis., Conclusion: There are clear differences in both therapeutic sustainability and intended clinical effect of ILS compared to posterolateral fusion with pedicle screw fixation after decompression for spinal stenosis. There are CCS differences between coflex and fusion cohorts noted at four years post-op similar to the trends revealed in the two year data used for PMA approval. When therapeutic sustainability outcomes are added to the CCS, ILS is proven to be a sustainable treatment for stabilization of the vertebral motion segment after decompression for lumbar spinal stenosis.

Objective: To compare the two-year clinical outcomes of a prospective, randomized controlled trial of an FDA-approved interspinous spacer with the compilation of published findings from 19 studies of decompressive laminectomy for the treatment of lumbar spinal stenosis., Methods: Back and leg pain, Oswestry disability index (ODI), and Zurich Claudication Questionnaire (ZCQ) values were compared between spacer- and laminectomy-treated patients preoperatively and at 12 and 24 months., Results: Percentage improvements between baseline and 24 months uniformly favored patients treated with the spacer for back pain (65% vs. 52%), leg pain (70% vs. 62%), ODI (51% vs. 47%) and ZCQ symptom severity (37% vs. 29%) and physical function (36% vs. 32%)., Conclusion: Both treatments provide effective and durable symptom relief of claudicant symptoms. This stand-alone interspinous spacer offers the patient a minimally invasive option with less surgical risk.

Study Design: This is a detailed description of a facet-sparing decompression technique and a prospective observational study of 59 subjects., Objective: To describe a facet-sparing decompression technique, quantify operative parameters, adverse events, and anatomic changes following decompression with a flexible microblade shaving system., Summary of Background Data: Decompression in patients with lumbar spinal stenosis is a common surgical procedure. However, obtaining a thorough decompression while leaving enough tissue to avoid destabilization can be challenging. Decompression with a flexible, through-the-foramen system may mitigate some of these challenges., Materials and Methods: Fifty-nine subjects diagnosed with lumbar spinal stenosis were recruited into this study. Subjects underwent decompression with a flexible, microblade decompression system at a total of 88 levels between L2 and S1. Subject demographics, details of the procedure, and operation, including adverse events were collected. Preoperative and postoperative computed tomography scans and plain radiographs were obtained from a subset of 12 subjects and quantitatively assessed for bone removal and preservation of stabilizing structures., Results: Fifty-nine subjects had 88 levels treated, 51% single-level and 49% 2-level with L4-L5 being the most commonly decompressed level. Operative time, blood loss, and length of stay were similar to or less than that seen in the historical control. The system was successfully used for decompression in 95.8% of the attempted foramina. Three operative complications were reported, all dural tears (5.1%). These dural tears occurred before introduction of the flexible decompression system. Computed tomography scans from 12 subjects demonstrate access to the lateral recess and foramen with removal of <6% of the superior facet cross-sectional area., Conclusions: The flexible microblade shaving system provided thorough decompression with few intraoperative complications. Operative variables were favorable compared to the literature and radiographic decompression was achieved to a great extent while allowing for the preservation of the facet joints and midline structures.

Background: Anterior cervical fusion, an established procedure to treat cervical radiculopathy, sacrifices the natural function of the disc, while placing increased stresses on adjacent spinal levels. In contrast, the cervical total disc replacement (cTDR) maintains motion and decreases adjacent-level stresses. The purpose of this study was to investigate the safety and effectiveness of a next-generation cTDR device in patients with symptomatic cervical radiculopathy., Methods: This is a multicenter Food and Drug Administration-regulated feasibility study to evaluate safety and effectiveness of the M6-C Artificial Cervical Disc for the treatment of patients with symptomatic cervical radiculopathy at 1 or 2 levels from C3 to C7. Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form 36 Health Survey (SF-36), safety, and radiographic outcomes were assessed preoperatively, at 6 weeks and 3, 6, 12, and 24 months postoperatively., Results: Thirty patients were enrolled at 3 clinical sites. Patients were implanted at either 1 or 2 levels. Mean NDI improved from 67.8 to 20.8 (P < .0001) at 24 months. Significant improvement was also observed through 24-month follow-up in neck and arm pain VAS (P < .0001) and in physical (P < .005) and mental component scores of the SF-36 at 3, 6, and 12 months (P < .008). There were no serious adverse events related to the device or procedure as adjudicated by an independent clinical events committee. Radiographically, disc space height increased more than 50% with a correlative increase in the postoperative disc angle. Range of motion decreased slightly from baseline during early follow-up but increased slightly and were maintained throughout the follow-up period., Conclusions: The M6-C cervical artificial disc represents a new generation of cTDR design. Results of this study found the M6-C device to produce positive clinical and radiographic outcomes similar to other cTDRs, warranting further investigation.

Minimally invasive approaches and operative techniques are becoming increasingly popular for the treatment of cervical spine disorders. Minimally invasive spine surgery attempts to decrease iatrogenic muscle injury, decrease pain, and speed postoperative recovery with the use of smaller incisions and specialized instruments. This article explains in detail minimally invasive approaches to the posterior spine, the techniques for posterior cervical foraminotomy and arthrodesis via lateral mass screw placement, and anterior cervical foraminotomy. Complications are also discussed. Additionally, illustrated cases are presented detailing the use of minimally invasive surgical techniques., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Object: Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy., Methods: The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate., Results: A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group)., Conclusions: Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.

With the aging of the population, the number of patients suffering from progressive lumbar spinal stenosis with symptomatic neurogenic intermittent claudication is projected to increase. Unfortunately, these patients are limited to a choice between nonsurgical conservative care and more invasive decompressive surgical procedures such as laminectomy with or without fusion. The X STOP interspinous process decompression system is a commercially available device that provides a minimally invasive alternative treatment, an intermediate option within the continuum of care for these patients. The X STOP is appropriate for patients with moderately severe functional impairment whose symptoms are exacerbated in extension and relieved in flexion. Implanted between the spinous processes without disrupting the normal anatomical structures, the X STOP limits narrowing of the spinal canal and neural foramina by reducing extension at the symptomatic level(s). In this report the author details the approved indications for use of the X STOP and discusses several illustrative cases.

Background Context: The use of recombinant bone morphogenetic protein-2 (rh-BMP-2) is effective in augmenting lumbar spinal fusions. A safe, effective dosage of rh-BMP-2 in the cervical spine has yet to be determined. Use of rh-BMP-2 is currently being evaluated and is only indicated for use in the cervical spine on Investigational Device Exempt cases., Purpose: To present a potentially serious adverse event that may occur when using rh-BMP-2 in cervical spine surgery., Study Design: An emergent sequence of events including physical examination, radiographic studies, intubation, and surgical exploration were performed upon arrival to the emergency department., Methods: We report a case of a 54-year-old male patient presenting with neck swelling and difficulty swallowing 5 days after anterior cervical discectomy and fusion (ACDF) using rh-BMP-2., Results: The patient was found to have massive neck swelling including the pharyngeal tissue. The patient was admitted to the intensive care unit where parenteral steroids were administered for 24 hours during monitored intubation. The patient was extubated on the second hospital day and discharged home on the fourth hospital day after swelling subsided., Conclusions: Caution should be exercised with rh-BMP-2 use in ACDF surgery as the correct dose and technique for application is not yet determined. Respiratory distress and dysphagia may result secondary to rh-BMP-2 induced anterior neck swelling.

Spinal deformity has classically and historically been studied by those in the discipline of orthopedic surgery. This may be attributable to the orthopedic interventionalists' experience with osseous fixation for long-bone and other skeletal fractures. Neurosurgeons have maintained a long-standing interest in complex cervical spinal disorders, and their interest in the larger field of complex spinal deformity has been expanding. An understanding of spinal deformity disorders, biomechanics, bone biology, and metallurgy is necessary before clinical, teaching, and research activities can be undertaken within neurosurgery. The authors describe basic and advanced concepts of spinal deformity management with cases to illustrate teaching points.

Neurological injury to the lumbosacral plexus associated with pelvic and sacral fractures has traditionally been treated conservatively, despite significant and often debilitating functional deficits of the lower extremities. The authors report a case of reconstruction of the lumbosacral plexus, including nerve grafting to restore lower-extremity function caused by severe trauma to the pelvis. A 16-year-old boy sustained pelvic and sacral fractures in a motor vehicle accident. After stabilization of his orthopedic injuries, he suffered from paresis of his right gluteal and hamstring muscles and had no motor or sensory function below his knee. Two months later, he underwent reconstruction of his lumbosacral plexus performed using a nerve graft from his L-5 and S-1 nerve roots proximal to the inferior gluteal nerve and distal to a branch to the hamstring muscles. After another 2 months, his recovering saphenous nerve was transferred to the sensory component of the posterior tibial nerve by using cabled sural nerve grafts to restore sensation to the sole of his foot. After 2.5 years, he experienced reinnervation of his gluteal and hamstring muscles and could perceive vibration on the sole of his foot. With the assistance of a foot-drop splint, the patient ambulates well and is able to ski. Operative details and the relevant literature are reviewed.

Object: The authors evaluated cervical spine radiographs to determine sagittal alignment in patients who underwent one- or two-level arthroplasty with the Bryan cervical artificial disc prosthesis., Methods: The curvature of the surgically treated spinal segments and the overall curvature of the cervical spine were evaluated in 13 patients who underwent 16 cervical arthroplasty device placements. Preoperative and postoperative lateral radiographs were reviewed and compared using standardized techniques for measuring spinal curvature. Patients who underwent a single-level cervical arthroplasty had a 4.7 degrees mean reduction (p < 0.05) in lordosis after cervical artificial disc replacement. The three patients who underwent two-level cervical arthroplasty had no significant changes in the sagittal alignment., Conclusions: Patients who underwent arthroplasty with a Bryan cervical artificial disc had a focal loss of lordosis (that is, kyphosis) at the treated levels after single-level procedures. Nevertheless, there was no significant change in the overall sagittal curvature of the cervical spine after single-level artificial disc replacements. The patients who underwent two-level artificial disc placement had no significant changes in lordosis at the treated levels or in the overall curvature. The likely source of this outcome appears to be the endplate milling procedures that reorient the vertebral endplates.

Object: The authors conducted a prospective study to evaluate the clinical and radiological outcomes and complications associated with uni- and bilateral transforaminal lumbar interbody fusion (TLIF) performed using carbon fiber Brantigan I/F Cages and pedicle screw fixation., Methods: Forty-two consecutive patients who had undergone uni- or bilateral TLIF between February 1999 and July 2000 were prospectively evaluated. Clinical outcome was graded using a modified Prolo Scale, the McGill Pain Index Scale, a follow-up questionnaire, and charts. An independent radiologist assessed radiological outcomes. All patients were followed for at least 1 year. Based on Prolo Scale scores, an excellent or good 1-year outcome was achieved in 73% of patients; 90% of patients responded that they would undergo the procedure again. At 1 year, radiographic fusion was demonstrated in 74% and was statistically related to clinical outcome (p < 0.05). There were no deaths or major hardware failures. Complications requiring repeated surgery included one case of cerebrospinal fluid (CSF) leakage and one case in which the hemovac drain was retained. There were four cases involving minor wound infections, eight involving CSF leaks, and none requiring repeated surgery. On routine follow-up radiography one pedicle screw was found to be broken; the patient remained asymptomatic and fusion occurred., Conclusions: Unilateral and bilateral TLIF involving placement of carbon fiber cages and pedicle screw fixation are effective treatment options in patients with indications for lumbar arthrodesis. The procedures result in acceptable rates of fusion and clinical success, and a minimal incidence of morbidity when performed by an experienced surgeon.

Object: The objective of this study was to identify specific independent risk factors for surgical site infections (SSIs) occurring after laminectomy or spinal fusion., Methods: The authors performed a retrospective case-control study of data obtained in patients between 1996 and 1999 who had undergone laminectomy and/or spinal fusion. Forty-one patients with SSI or meningitis were identified, and data were compared with those acquired in 178 uninfected control patients. Risk factors for SSI were determined using univariate analyses and multivariate logistic regression. The spinal surgery-related SSI rate (incisional and organ space) during the 4-year study period was 2.8%. Independent risk factors for SSI identified by multivariate analysis were postoperative incontinence (odds ratio [OR] 8.2, 95% confidence interval [CI] 2.9-22.8), posterior approach (OR 8.2, 95% CI 2-33.5), procedure for tumor resection (OR 6.2, 95% CI 1.7-22.3), and morbid obesity (OR 5.2, 95% CI 1.9-14.2). In patients with SSI the postoperative hospital length of stay was significantly longer than that in uninfected patients (median 6 and 3 days, respectively; p < 0.001) and were readmitted to the hospital for a median additional 6 days for treatment of their infection. Repeated surgery due to the infection was required in the majority (73%) of infected patients., Conclusions: Postoperative incontinence, posterior approach, surgery for tumor resection, and morbid obesity were independent risk factors predictive of SSI following spinal surgery. Interventions to reduce the risk for these potentially devastating infections need to be developed.

Object: The authors' goal was to determine whether the incidence of postoperative sore throat, hoarseness, and dysphagia associated with anterior spine surgery is reduced by maintaining endotracheal tube cuff pressure (ETCP) at 20 mm Hg during the period of neck retraction., Methods: Fifty-one patients scheduled for anterior cervical spine surgery were enrolled. After intubation, ETCP was adjusted to 20 mm Hg in all patients. Following placement of neck retractors, ETCP was measured. Patients were randomized to a control (no adjustment) or treatment group (ETCP adjusted to 20 mm Hg). A blinded observer questioned the patients about the presence of sore throat, dysphagia, and hoarseness at 1 hour, 24 hours, and 1 week postoperatively. No differences between groups at 1 hour postoperatively were demonstrated. At 24 hours, 51% of patients in the treatment group complained of sore throat compared with 74% of control patients (p < 0.05). Sixty-five percent of the women experienced sore throat compared with 35% of the men (p < 0.05). At 24 hours, longer retraction time correlated with development of dysphagia (p < 0.05, r2 = 0.61). At 24 hours, hoarseness was present in 65% of women and 20% of men (p < 0.05)., Conclusions: The results of this study suggest the following three predictors of postoperative throat discomfort following anterior cervical spine surgery in which neck retraction is performed: increased ETCP during neck retraction (sore throat), neck retraction time (dysphagia), and female sex (sore throat and hoarseness). The simple maneuver of decreasing ETCP to 20 mm Hg may be helpful in improving patient comfort following anterior cervical spine surgery.

Objective: To survey a large number of neurosurgical spine surgeons for data regarding the presence of risk factors in patients experiencing visual loss after spine surgery., Methods: A survey was sent to current members (as of 1997) of the American Association of Neurological Surgeons/Congress of Neurological Surgeons, Section on Disorders of the Spine and Peripheral Nerves, with questions focusing on intraoperative factors that may predispose patients to perioperative visual loss., Results: Two hundred ninety surveys were returned, and 24 patients with visual loss after spine surgery were reported by 22 surgeons. Although many of these patients had probable causative factors for visual loss after surgery (e.g., hypotension, low hematocrit level, coexisting disease), some did not (n = 8)., Conclusion: These results suggest the necessity of a high index of suspicion for evolving perioperative visual loss even in the absence of risk factors.

Objective and Importance: Traumatic fracture-dislocations of the lumbosacral junction are rare, with all previously reported cases involving fracture-dislocations at a single level. No cases of multiple fracture-dislocations of contiguous spinal segments in the lumbosacral spine have been reported. A case of traumatic adjacent fracture-dislocations of the fifth lumbar segment is presented., Clinical Presentation: An 18-year-old male patient sustained open lumbar spinal trauma after a motor vehicle accident. A neurological examination revealed an L4 level. Radiographic evaluation of the spine revealed a three-column injury at L5 with spondyloptosis of the L5 vertebral body. Aorto-ilio-femoral angiography revealed no evidence of vascular injury., Intervention: The patient was treated with a combined anterior and posterior approach in a two-stage operation. Six months postoperatively, he was neurologically unchanged; however, he was able to walk with the aid of a cane. Plain films revealed normal alignment of the lumbosacral spine., Conclusion: The management of traumatic lumbosacral fracture-dislocations requires careful consideration of retroperitoneal structures and possible exploration of the iliac vessels in addition to spinal reconstruction.

Objective: Bone morphogenetic proteins can serve as adjuncts to autologous bone to achieve bony fusion, and recombinant BMPs such as osteogenic protein-1 (OP-1) have the potential to replace autologous bone altogether as fusion substrate. However, relatively little is known about the safety of OP-1 for spinal fusion procedures. This study examined the effects of OP-1 intentionally placed in the subarachnoid space following thecal sac decompression, and used as graft substrate in a canine dorsolateral lumbar spine fusion model., Methods: Lumbar decompression with dorsolateral fusion was performed on 30 canines. The dura was opened to simulate an intraoperative rent and OP-1 was placed in the subarachnoid space and in the fusion bed. Animals were sacrificed after 16 weeks and the spines were examined manually, radiographically and pathologically., Results: All animals treated with OP-1 developed new bone in the subarachnoid space. This bone compressed the spinal cord, but no clinical or pathological features of neurotoxicity were noted. Mild spinal stenosis was noted at the site of dural decompression in the OP-1 treated animals. Over 80% of animals treated with OP-1 developed fusion as assessed by palpation (52% by CT criteria), while only 25% of control animals fused., Conclusions: Recombinant human OP-1 is effective at promoting fusion in a canine dorsolateral lumbar spine fusion model. However, bone growth can occur over exposed, decompressed dura, and it can form in the subdural and subarachnoid spaces. The use of OP-1 as an adjunct to spinal fusion appears to have merit, but its use must be carefully controlled to avoid unwanted bone formation and subsequent neural compression.

The authors report a case of an aggressive chordoma in the cervical spine of a 15-year-old girl who underwent radical resection followed by reconstruction using an anterior vascularized fibular strut graft and posterior arthrodesis prior to receiving immediate postoperative radiation therapy. The patient had successful graft incorporation 4 months postoperatively. The authors review the advantages of using vascularized fibular strut grafts for the treatment of multilevel cervical spine neoplastic disease and discuss the theoretical advantages of using vascularized grafts that tolerate therapeutic levels of radiation.

A case of cervical spine injury related to bungee jumping is presented. Surgical intervention resulted in resolution of the patient's quadriparesis. The incidence of serious injury connected with this pastime is not inconsiderable, and it is recommended that safer jumping practices be followed. Inspection of bungee equipment and certification of instructors is now voluntary but should be mandated. Jumping heights should be limited and the use of air cushions encouraged.

Object: The 847 active members of the American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS) Section on Disorders of the Spine and Peripheral Nerves were surveyed to quantitate the risk of vertebral artery (VA) injury during C1-2 transarticular screw placement., Methods: This retrospective study elicited the number of patients treated with transarticular screws, the number of screws placed, the incidence of VA injury and subsequent neurological deficit, and the management of known or suspected VA injury. Two hundred thirteen (25.1%) of the 847 surgeons responded. One hundred one respondents (47.4%) had placed a total of 2492 C1-2 transarticular screws in 1318 patients. Thirty-one patients (2.4%) had known VA injuries and an additional 23 patients (1.7%) were suspected of having injuries. However, only two (3.7%) of the 54 patients with known or suspected VA injuries exhibited subsequent neurological deficits and only one (1.9%) died of bilateral VA injury. Other iatrogenic complications included dural tears, screw fractures, screw breakout, fusion failure, infection, and suboccipital numbness., Conclusions: Including both known and suspected cases, the risk of VA injury was 4.1% per patient or 2.2% per screw inserted. The risk of neurological deficit from VA injury was 0.2% per patient or 0.1% per screw, and the mortality rate was 0.1%. The choice of management of intraoperative VA injuries was evenly divided between placing the patient under observation and initiating immediate postoperative angiography with possible balloon occlusion.

The authors report the use of high-dose botulinum toxin A for muscle relaxation prior to surgery for cervical spine fixation in two patients with dystonic cerebral palsy that included severe cervical dystonia. Both patients had recently developed progressive cervical myelopathy and surgery was planned to halt the insidious progressive weakness. However, marked dystonic posturing of the neck would have compromised their tolerance of halo fixation and subsequently impeded postoperative fusion. Preoperative chemodenervation of selected cervical muscles with injections of high-dose botulinum toxin A eliminated all involuntary neck movements, permitting the patients to tolerate halo fixation and facilitating postoperative spinal fusion. It is concluded that botulinum toxin A can be used safely and effectively in the preoperative management of patients with cervical dystonia and cervical spondylitic myelopathy.

Background: Focal gliomas involving the midbrain tectum and tegmentum have been identified as having a better prognosis than diffuse tumors affecting the brain stem. However, only limited information is available concerning treatment effectiveness and long term outcome for these patients., Methods: A retrospective, population-based cancer registry survey was performed to assess the clinical features and treatment courses of patients with focal midbrain tumors., Results: Sixteen patients with midbrain gliomas were identified; eight had tectal gliomas and eight tegmental gliomas. Thirteen patients presented with symptoms related to hydrocephalus, and 12 required a ventriculoperitoneal shunt. Seven patients underwent surgery directed at the tumor. Eight patients underwent initial radiation therapy and none had initial chemotherapy. One patient diagnosed at age 18 months had a rapidly growing tumor after 14 months of follow up which has responded to chemotherapy. The mean survival of this patient population was 84 months (range 3-280 months) after diagnosis, with only one tumor related death occurring (280 months after diagnosis). Survival was not affected by tumor location within the midbrain (tegmental or tectal) or by whether radiation therapy was or was not administered., Conclusions: Patients with focal midbrain gliomas require symptom control aimed at treatment of hydrocephalus, or mass effect from the tumor. However the extended survival of this population suggests that routine aggressive surgical debulking is often not required. Furthermore, the routine use of radiation therapy or chemotherapy for all such patients is questioned.

The authors report a case of branchial cleft cyst for which the location and presentation of the lesion were unusual. This abnormality should be considered in the differential diagnosis of cystic lesions of the parapharyngeal space. The presence of multiple cranial nerve palsies in association with a mass in this region does not necessarily indicate a neoplastic lesion.