Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study.

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.

Facet-sparing decompression with a minimally invasive flexible microblade shaver: a prospective operative analysis.

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.

Anterior Cervical Foraminotomy for Radiculopathy After Cervical Artificial Disc Replacement: Technique Description and Case Report.

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.

Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study.

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.

Anatomical relationship of the internal carotid artery to C-1: clinical implications for screw fixation of the atlas.

OBJECT: Various C1-2 instrumentation techniques have been developed to treat atlantoaxial instability. Screw fixation of C1-2 poses a risk of injury to the vertebral artery and internal carotid artery (ICA). Injury to the ICA caused by C-1 screws is extremely rare, but has been described. To characterize this risk, the authors studied the anatomical relationship of the ICA to the lateral mass of C-1. METHODS: The authors studied 100 patients who had undergone computed tomography scanning and magnetic resonance imaging of the neck to assess the position of the ICA in association with the C-1 lateral mass. Each ICA was classified into 1 of the following 4 zones: Zone 1 (medial to lateral mass), Zone 2 (medial half of lateral mass), Zone 3 (lateral half of lateral mass), and Zone 4 (lateral to lateral mass). For patients with an ICA ventral to the lateral mass, the shortest distance between the ICA and lateral mass was measured to determine the margin of error with an overpenetrated bicortical screw. RESULTS: Of the 100 patients, 58% had a left ICA in Zones 2 and 3 with a mean distance from the anterior cortex of 3.5+/-1.5 mm (+/- standard deviation), and 74% had a right ICA in Zones 2 and 3 with a mean distance from the anterior cortex of 3.9+/-1.6 mm. Both ICAs anterior to the lateral mass were noted in 47% of patients, and 84% had >or= 1 ICA anterior to the lateral mass. When the ICA was anterior to the lateral mass, it was more commonly in the lateral half (left ICA in 91% and right ICA in 92%). The left ICA was in Zone 1 in 1% and Zone 4 in 41%. The right ICA was in Zone 1 in 1% and Zone 4 in 25%. CONCLUSIONS: A high percentage of patients demonstrate an ICA directly ventral to the C-1 lateral mass, which poses a risk of ICA injury caused by an overpenetrated bicortical screw.

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

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).

Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion: a case study.

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.

Appropriate selection of patients with lumbar spinal stenosis for interspinous process decompression with the X STOP device.

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.

Use of Nanocrystalline Hydroxyapatite With Autologous BMA and Local Bone in the Lumbar Spine: A Retrospective CT Analysis of Posterolateral Fusion Results.

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.

Improving C1-C2 Complex Fusion Rates: An Alternate Approach.

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.

Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis.

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.

Are Collapsed Cervical Discs Amenable to Total Disc Arthroplasty?: Analysis of Prospective Clinical Data With 2-Year Follow Up.

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.

Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial.

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.

Nerve reconstruction in lumbosacral plexopathy. Case report and review of the literature.

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.

The changing role for neurosurgeons and the treatment of spinal deformity.

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.

Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment.

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.

Stand-alone interspinous spacer versus decompressive laminectomy for treatment of 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.

Effects of decreasing endotracheal tube cuff pressures during neck retraction for anterior cervical spine surgery.

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.

Risk factors for surgical site infection in spinal surgery.

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.

Accurate identification of adverse outcomes after cervical spine surgery.

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.