Emory University Orthopaedics and Spine Hospital

BACKGROUND: Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials. METHODS: Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years. RESULTS: A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years. CONCLUSIONS: In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically. (ClinicalTrials.gov number, NCT00000411 [ClinicalTrials.gov].).

The functional interpretation of high throughput metabolomics by mass spectrometry is hindered by the identification of metabolites, a tedious and challenging task. We present a set of computational algorithms which, by leveraging the collective power of metabolic pathways and networks, predict functional activity directly from spectral feature tables without a priori identification of metabolites. The algorithms were experimentally validated on the activation of innate immune cells.

Study Design. A prospective randomized clinical study was conducted. Objective. To determine whether the dose and carrier that were successful in rhesus monkeys could induce consistent radiographic spine fusion in humans. Summary of Background Data. Preclinical studies have demonstrated that recombinant human bone morphogenetic protein-2 (rhBMP-2), an osteoinductive bone morphogenetic protein, is successful at generating spine fusion in rabbits and rhesus monkeys. Methods. For this study, 25 patients undergoing lumbar arthrodesis were randomized (1:2:2 ratio) based on the arthrodesis technique: autograft/Texas Scottish Rite Hospital (TSRH) pedicle screw instrumentation (n = 5), rhBMP-2/TSRH (n = 11), and rhBMP-2 only without internal fixation (n = 9). On each side, 20 mg of rhBMP-2 were delivered on a carrier consisting of 60% hydroxyapatite and 40% tricalcium phosphate granules (10 cm3/side). The patients had single-level disc degeneration, Grade 1 or less spondylolisthesis, mechanical low back pain with or without leg pain, and at least 6 months failure of nonoperative treatment. Results. All 25 patients were available for follow-up evaluation (mean, 17 months; range 12–27 months). The radiographic fusion rate was 40% (2/5) in the autograft/TSRH group and 100% (20/20) with rhBMP-2 group with or without TSRH internal fixation (P = 0.004). A statistically significant improvement in Oswestry score was seen at 6 weeks in the rhBMP-2 only group (−17.6;P = 0.009), and at 3 months in the rhBMP-2/TSRH group (−17.0;P = 0.003), but not until 6 months in the autograft/TSRH group (−17.3;P = 0.041). At the final follow-up assessment, Oswestry improvement was greatest in the rhBMP-2 only group (−28.7, P < 0.001). The SF-36 Pain Index and PCS subscales showed similar changes. Discussion. This pilot study is the first with at least 1 year of follow-up evaluation to demonstrate successful posterolateral spine fusion using a BMP-based bone graft substitute, with radiographs and CT scans as the determinant. Consistently, rhBMP-2 was able to induce bone in the posterolateral lumbar spine when delivered at a dose of 20 mg per side with or without the use of internal fixation. Patients with spondylolisthesis classified higher than Meyerding Grade 1 or with more than 5 mm of translational motion may still require internal fixation. Some patients did smoke during the postoperative period, and all in the rhBMP-2 groups still obtained solid fusions. Conclusions. Consistently, rhBMP-2 with the biphasic calcium phosphate granules induced radiographic posterolateral lumbar spine fusion with or without internal fixation in patients whose spondylolisthesis did not exceed Grade 1. Statistically greater and quicker improvement in patient-derived clinical outcome was measured in the rhBMP-2 groups.

In Brief Study Design. Randomized trial and concurrent observational cohort study. Objective. To compare 4 year outcomes of surgery to nonoperative care for spinal stenosis. Summary of Background Data. Surgery for spinal stenosis has been shown to be more effective compared to nonoperative treatment over 2 years, but longer-term data have not been analyzed. Methods. Surgical candidates from 13 centers in 11 US states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort (RC) or observational cohort (OC). Treatment was standard decompressive laminectomy or standard nonoperative care. Primary outcomes were SF-36 bodily pain (BP) and physical function scales and the modified Oswestry Disability index assessed at 6 weeks, 3 months, 6 months, and yearly up to 4 years. Results. A total of 289 patients enrolled in the RC and 365 patients enrolled in the OC. An as-treated analysis combining the RC and OC and adjusting for potential confounders found that the clinically significant advantages for surgery previously reported were maintained through 4 years, with treatment effects (defined as mean change in surgery group minus mean change in nonoperative group) for bodily pain 12.6 (95% confidence interval [CI], 8.5–16.7); physical function 8.6 (95% CI, 4.6–12.6); and Oswestry Disability index −9.4 (95% CI, −12.6 to −6.2). Early advantages for surgical treatment for secondary measures such as bothersomeness, satisfaction with symptoms, and self-rated progress were also maintained. Conclusion. Patients with symptomatic spinal stenosis treated surgically compared to those treated nonoperatively maintain substantially greater improvement in pain and function through 4 years. Four-year outcomes for the Spine Patient Outcomes Research Trial spinal stenosis surgical and nonoperative cohorts are reported. Overall, 419 patients received surgery at some point during the first 4 years; 235 remained nonoperative. The proportion of enrollees who supplied data at each follow-up visit interval ranged from 67% to 89% with losses due to dropouts, missed visits, or deaths. The as-treated analysis combining the randomized and observational cohorts and adjusting for potential confounders found that the clinically significant advantages for surgery previously reported were maintained through 4 years.

STUDY DESIGN: A prospective, randomized, multicenter study of surgical treatment of cervical disc disease. OBJECTIVE: To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up. SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success. METHODS: We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery. RESULTS: Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequent to the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015). CONCLUSION: Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease.

BACKGROUND: Cervical spondylotic myelopathy is the leading cause of spinal cord dysfunction worldwide. The objective of this study was to evaluate the impact of surgical decompression on functional, quality-of-life, and disability outcomes at one year after surgery in a large cohort of patients with this condition. METHODS: Adult patients with symptomatic cervical spondylotic myelopathy and magnetic resonance imaging evidence of spinal cord compression were enrolled at twelve North American centers from 2005 to 2007. At enrollment, the myelopathy was categorized as mild (modified Japanese Orthopaedic Association [mJOA] score ≥ 15), moderate (mJOA = 12 to 14), or severe (mJOA < 12). Patients were followed prospectively for one year, at which point the outcomes of interest included the mJOA score, Nurick grade, Neck Disability Index (NDI), and Short Form-36 version 2 (SF-36v2). All outcomes at one year were compared with the preoperative values with use of univariate paired statistics. Outcomes were also compared among the severity classes with use of one-way analysis of variance. Finally, a multivariate analysis that adjusted for baseline differences among the severity groups was performed. Treatment-related complication data were collected and the overall complication rate was calculated. RESULTS: Eighty-five (30.6%) of the 278 enrolled patients had mild cervical spondylotic myelopathy, 110 (39.6%) had moderate disease, and 83 (29.9%) had severe disease preoperatively. One-year follow-up data were available for 222 (85.4%) of 260 patients. There was a significant improvement from baseline to one year postoperatively (p < 0.05) in the mJOA score, Nurick grade, NDI score, and all SF-36v2 health dimensions (including the mental and physical health composite scores) except general health. With the exception of the change in the mJOA, the degree of improvement did not depend on the severity of the preoperative symptoms. These results remained unchanged after adjusting for relevant confounders in the multivariate analysis. Fifty-two patients experienced complications (prevalence, 18.7%), with no significant differences among the severity groups. CONCLUSIONS: Surgical decompression for the treatment of cervical spondylotic myelopathy was associated with improvement in functional, disability-related, and quality-of-life outcomes at one year of follow-up for all disease severity categories. Furthermore, complication rates observed in the study were commensurate with those in previously reported cervical spondylotic myelopathy series.

STUDY DESIGN: Biomechanical comparison of the pull-out strengths of lateral mass and pedicle screws in the human cervical spine. Measurements of pedicle dimensions and orientation were compiled. OBJECTIVES: To determine if transpedicular screws provide greater pull-out resistance than lateral mass screws and to investigate the anatomic feasibility of pedicle screw insertion. SUMMARY OF BACKGROUND DATA: Cervical pedicle screws have been reported in limited clinical and biomechanical studies, and some quantitative cervical pedicle anatomy has been reported. No direct biomechanical comparisons have been made between lateral mass and pedicle screws. METHODS: Fifty-six fresh disarticulated human vertebrae (C2-C7) were evaluated with computed tomography to determine morphometry and vertebral body bone density. Lateral mass and pedicle screws were randomized to left versus right. A 3.5-mm cortical screw was used for both techniques, unless a pedicle was narrower than 5.0 mm; then a 2.7-mm cortical screw was used instead. Pedicle wall violations were recorded. Screws were subjected to a uniaxial load to failure. Mean pedicle height, width, and angle with respect to the vertebral midline were tabulated for each level. RESULTS: The mean load-to-failure was 677 N for the cervical pedicle screws and 355 N for the lateral mass screws. No significant correlations for either screw type were found between pull-out strength and bone density, screw length, or vertebral level. Pedicle and lateral mass dimensions were highly variable and not predictive of pull-out strength. Seven (13%) minor pedicle wall violations were observed. CONCLUSIONS: Cervical pedicle screws demonstrated a significantly higher resistance to pull-out forces than did lateral mass screws. The variability in pedicle morphometry and orientation requires careful preoperative assessment to determine the suitability of pedicle screw insertion.

STUDY DESIGN: Prospective observational cohort study with matched and unmatched comparisons. Level II evidence. OBJECTIVE: The purpose of this study is to compare results of adult symptomatic lumbar scoliosis (ASLS) patients treated nonoperatively and operatively. This is an evidence-based prospective multicenter study to answer the question of whether nonoperative and operative treatment improves the quality of life (QOL) in these patients at 2-year follow-up. SUMMARY OF BACKGROUND DATA: Only 1 paper in the peer-reviewed published data directly addresses this question. That paper suggested that operative treatment was more beneficial than nonoperative care, but the limitations relate to historical context (all patients treated with Harrington implants) and the absence of validated patient-reported QOL (QOL) data. METHODS: This study assesses 160 consecutively enrolled patients (ages 40-80 years) with baseline and 2-year follow-up data from 5 centers. Lumbar scoliosis without prior surgical treatment was defined as a minimum Cobb angle of 30 degrees (mean: 54 degrees for patients in this study). All patients had either an Oswestry Disability Index (ODI) score of 20 or more (mean: 33) or Scoliosis Research Society (SRS) domain scores of 4 or less in pain, function, and self-image (mean: 3.2) at baseline. Pretreatment and 2-year follow-up data collected prospectively included basic radiographic parameters, complications and SRS QOL, ODI, and Numerical Rating Scale back and leg pain scores. RESULTS: At 2 years, follow-up on the operative patients was 95% and for the nonoperative patients it was 45%. The demographics for the nonoperative patients who were followed up for 2 years versus those who were lost to follow-up were identical. The operative cohort significantly improved in all QOL measures. The nonoperative cohort did not improve and nonsignificant decline in QOL scores was common. At minimum 2-year follow-up, operative patients outperformed nonoperative patients by all measures. CONCLUSION: It would appear from this study that common nonoperative treatments do not change the QOL in patients with ASLS at 2-year follow-up. However, operative treatment does significantly improve the QOL for this group of patients. Our conclusions are limited by the fact that we were only able to follow-up 45% of the nonoperative group to 2-year follow-up, in spite of extensive efforts on our part to accomplish such.

In Brief Study Design/Setting. Independent, retrospective clinical record review with a concurrent control. Objective. To identify whether rhBMP-2 is associated with an increased incidence of clinically relevant postoperative prevertebral swelling problems in patients undergoing anterior cervical fusions. Summary of Background Data. Bone Morphogenetic Protein-2 (rhBMP-2) is FDA approved as a bone graft substitute in anterior lumbar interbody fusions. rhBMP-2 has also been used “off-label” in anterior cervical fusions. We suspected that rhBMP-2 might increase the incidence of adverse swelling events. Methods. A total of 234 consecutive patients (ages 12–82 years) undergoing anterior cervical fusion with and without rhBMP-2 over a 2-year period at one institution comprised the study population. The incidence of clinically relevant prevertebral swelling was calculated. The populations were compared and statistical significance was determined. Results. A total of 234 patients met the study criteria, 69 of whom underwent anterior cervical spine fusions using rhBMP-2; 27.5% of those patients in the rhBMP-2 group had a clinically significant swelling event versus only 3.6% of patients in the non-rhBMP-2 group. This difference was statistically significant (P < 0.0001) and remained so after controlling for other significant predictors of swelling. Conclusions. Off-label use of rhBMP-2 in the anterior cervical spine is associated with an increased rate of clinically relevant swelling events. A total of 234 consecutive patients undergoing anterior cervical fusion with and without rhBMP-2 were studied. 27.5% of patients in the rhBMP-2 group had a clinically significant swelling event versus 3.6% in the control group with an odds ratio of 10.1 (P < 0.0001). The difference remained significant after controlling for other predictors of swelling.

OBJECTIVE: The purpose of this investigation was to develop, characterize, and validate an animal model for lumbar intertransverse process fusion. STUDY DESIGN: This study used a rabbit model to characterize the radiographic, histologic, and biomechanical properties of the intertransverse process spinal fusion healing process. METHODS: Sixty adult New Zealand white rabbits underwent bilateral posterolateral spinal fusion at L5-L6 using autogenous iliac bone graft. Four of the rabbits were used as negative controls: two received bone graft without decortication of the transverse process, and two underwent decortication without bone grafting. Rabbits were killed at 2, 3, 4, 5, 6, or 10 weeks and the spinal fusions were analyzed by radiography, manual palpation, and uniaxial tensile mechanical testing or light microscopy. RESULTS: Overall the nonunion rate was 33% in animals 4 or more weeks from surgery. Biomechanical strength and stiffness of the fusions became statistically different from the adjacent unfused control levels after the third week (P < 0.05). Tensile strength of the nonunions (1.4 times unfused control levels) was statistically less (P < 0.05) than that of the solidly fused levels (1.8 times unfused controls) in weeks 4, 5, 6, and 10. Fusion was not achieved in any of the control animals with omission of decortication or bone grafting. Light microscopic analysis showed three distinct and reproducible phases of spinal fusion healing. CONCLUSIONS: This animal model overcomes the limitations of previous models by more closely replicating the human procedure in surgical technique, graft healing environment, and outcome (i.e., a nonunion rate similar to that seen in humans). This model provides an opportunity to explore questions relevant to the biology of intertransverse process fusion and to investigate the coupling of the membranous and endochondral mechanisms of bone formation during spinal fusion.

STUDY DESIGN: A matched cohort clinical and radiographic retrospective analysis of laminoplasty and laminectomy with fusion for the treatment of multilevel cervical myelopathy. OBJECTIVES: To compare the clinical and radiographic outcomes of two procedures increasingly used to treat multilevel cervical myelopathy. SUMMARY OF BACKGROUND DATA: Traditional methods of treating multilevel cervical myelopathy (laminectomy and corpectomy) are reported to have a notable frequency of complications. Laminoplasty and laminectomy with fusion have been advocated as superior procedures. A comparative study of these two techniques has not been reported. METHODS: Medical records of all patients treated for multilevel cervical myelopathy with either laminoplasty or laminectomy with fusion between 1994 and 1999 at our institution were reviewed. Thirteen patients that underwent laminectomy with fusion were matched with 13 patients that underwent laminoplasty. All patients and radiographs were independently evaluated at latest follow-up by a single physician. RESULTS: Cohorts were well matched based on patient age, duration of symptoms, and severity of myelopathy (Nurick grade) before surgery. Mean independent follow-up was similar (25.5 and 26.2 months). Both objective improvement in patient function (Nurick score) and the number of patients reporting subjective improvement in strength, dexterity, sensation, pain, and gait tended to be greater in the laminoplasty cohort. Whereas no complications occurred in the laminoplasty cohort, there were 14 complications in 9 patients that underwent laminectomy with fusion patients. Complications included progression of myelopathy, nonunion, instrumentation failure, development of a significant kyphotic alignment, persistent bone graft harvest site pain, subjacent degeneration requiring reoperation, and deep infection. CONCLUSIONS: The marked difference in complications and functional improvement between these matched cohorts suggests that laminoplasty may be preferable to laminectomy with fusion as a posterior procedure for multilevel cervical myelopathy.

STUDY DESIGN: Lumbar intertransverse process arthrodesis using recombinant human bone morphogenetic protein-2 was performed in a previously established rabbit model for posterolateral spinal fusion and compared with fusions achieved using autogenous bone graft. OBJECTIVES: To qualitatively compare different recombinant human bone morphogenetic protein-2 dosages and carriers and to determine the efficacy of recombinant human bone morphogenetic protein-2 as a bone graft substitute to produce lumbar intertransverse process fusion in a validated rabbit model for posterolateral spinal fusion. SUMMARY OF BACKGROUND DATA: Autogenous bone was considered the most successful bone graft material used for spinal arthrodesis. Problems with its use may occur in 25-30% of patients and prompted the search for and investigation of bone graft substitutes and osteoinductive growth factors, such as bone morphogenetic proteins. Recombinant human bone morphogenetic protein-2 was used successfully in orthotopic sites to generate bone in animal mandibular and long bone defect models. METHODS: Posterolateral intertransverse process arthrodeses were performed at L5-L6 in 56 rabbits using recombinant human bone morphogenetic protein-2 or autogenous bone graft. Rabbits were killed either 5 weeks later to qualitatively compare fusions achieved using different recombinant human bone morphogenetic protein-2 dosages and carriers or 4 weeks later to compare the efficacy of recombinant human bone morphogenetic protein-2 in achieving spinal fusion compared with using autogenous bone graft. Inspection, manual palpation, radiography, histology, and biomechanic testing were used to assess the fusion. RESULTS: All rabbits implanted with recombinant human bone morphogenetic protein-2 achieved solid spinal fusion by manual palpation and were fused radiographically, whereas only 42% of the autograft control fusions were solid. More mature fusions with greater trabecular bone formation were shown radiographically and histologically in rabbits implanted with the high-dose recombinant human bone morphogenetic protein-2 than with the low-dose recombinant human bone morphogenetic protein-2. Fusions achieved using recombinant human bone morphogenetic protein-2 delivered in the collagen carrier were more remodeled and homogeneous compared with using recombinant human bone morphogenetic protein-2 delivered in autograft +/- collagen carrier. Fusions achieved with recombinant human bone morphogenetic protein-2 were biomechanically stronger and stiffer than fusions achieved using autogenous bone graft. CONCLUSIONS: Recombinant human bone morphogenetic protein-2 successfully and reliably achieved lumbar intertransverse process fusion in a validated rabbit model for posterolateral spinal fusion. Radiographically and histologically, greater and more rapid bone formation, consolidation, and remodeling were shown with recombinant human bone morphogenetic protein-2 compared with autogenous bone graft. Fusions achieved with recombinant human bone morphogenetic protein-2 were biomechanically stronger and stiffer than autograft fusions.

STUDY DESIGN: Scoliosis patients were prospectively x-rayed in three positions with independent analysis. OBJECTIVES: To determine if one positioning technique provides superior visualization of critical landmarks (C7, T2, T12, L5-S1) and to determine any position dependent variations in regional measures or sagittal balance. SUMMARY OF BACKGROUND DATA: Different techniques for positioning patient's arms are used for 36" lateral radiograph with no data on relative effects. METHODS: A total of 25 scoliosis patients were prospectively studied with 36" lateral radiographs in three positions varying arm location (straight out, partially flexed, and the "clavicle" position). Films were analyzed independently by three surgeons. Vertebral landmarks were scored for clarity; and lordosis, kyphosis, and global balance were analyzed. Statistical analysis was done with a General Estimating Equations model. RESULTS: The overall visualization score for the clavicle position was superior to either the 60 degrees or 90 degrees positions (clavicle vs. 60 degrees, P < 0.0001; clavicle vs. 90 degrees, P < 0.0003). Analysis of vertebral landmarks showed significantly better visualization of T2 with clavicle versus 90 degrees (P < 0.047), better visualization of T12 with clavicle versus either 60 degrees (P < 0.006) or 90 degrees (P < 0.049), and better visualization of L5-S1 with clavicle versus 90 degrees (P < 0.02). Regional measures showed no differences, but sagittal balance was significantly more positive in the 60 degrees position than either clavicle (P < 0.04) or 90 degrees (P < 0.015). CONCLUSIONS: The clavicle position for obtaining lateral 36" radiographs produces significantly better overall visualization of critical vertebral landmarks. Regional measures do not differ between the three positions, but global balance is more positive with the 60 degrees position. Clinically, the clavicle position may result in more accurate radiographic measures and may minimize repeated radiograph exposures.

STUDY DESIGN: Reviews were conducted. OBJECTIVES: To review the biology of spine fusion healing, and to outline several fundamental principles required for the selection of a bone graft substitute. SUMMARY OF BACKGROUND DATA: More than 200,000 spine fusions are performed each year in the United States. The success of this procedure is limited by morbidity from iliac crest bone graft harvest and a nonunion rate that ranges from 10% to 40%. In recent years, there has been an increased understanding of the biology of spine fusion healing. In addition, there has been a focus on finding suitable substitutes for autogenous iliac crest bone graft to promote spine fusion. The selection of a specific bone graft substitute can be a daunting task for the surgeon. METHODS: The available literature was reviewed and combined with the author's personal experience. RESULTS: A basic understanding of the biology of healing in different types of spine fusions and the differences between different categories of bone graft substitutes can help surgeons organize the graft selection process. CONCLUSIONS: In general, purely osteoconductive substitutes are less effective in adult posterolateral spine fusions, but may be suitable in the anterior spine when it is rigidly immobilized. Osteoinductive substitutes are more likely to be successful as extenders, enhancers, or substitutes for posterolateral spine fusion.

STUDY DESIGN: Matched patient cohorts using retrospective chart and radiographic review with independent clinical and radiographic follow-up were reviewed. OBJECTIVE: To compare the clinical and radiographic outcomes of multilevel corpectomy and laminoplasty using an independent matched-cohort analysis. SUMMARY OF BACKGROUND DATA: The treatment of choice for multilevel cervical myelopathy remains a matter of investigation. For the decompression of three or more motion segments, multilevel corpectomy and laminoplasty have proven effective while avoiding the pitfalls of laminectomy. Direct clinical comparisons of these two procedures are few in number and are limited by the heterogeneity in their patient groups. METHODS: Medical records of all patients treated for multilevel cervical myelopathy with either multilevel corpectomy or laminoplasty between 1994 and 1999 at the Emory Spine Center were reviewed. From a pool of 38 patients meeting stringent inclusion and exclusion criteria, 13 patients who underwent multilevel corpectomy were blindly matched with 13 patients who underwent laminoplasty based on known prognostic criteria. A single physician independently evaluated each patient and their radiographs at their latest follow-up appointment. RESULTS: The cohorts were well matched by age, duration of symptoms, severity of myelopathy (Nurick grade), and preoperative sagittal alignment (C2-C7). Mean operative time, blood loss, and hospital stay were nearly identical. The mean follow-up for multilevel corpectomy and laminoplasty were 49 and 40 months, respectively. Improvement in function averaged 1.6 Nurick grades after laminoplasty and 0.9 grades after multilevel corpectomy (P > 0.05). Subjective improvements in strength, dexterity, sensation, pain, and gait were similar for the two operations. The prevalence of axial discomfort at the latest follow-up was the same for each cohort, but the analgesic requirements tended to be greater for patients who underwent multilevel corpectomy. Sagittal motion from C2 to C7 decreased by 57% after multilevel corpectomy and by 38% after laminoplasty. One complication (C6-C7 herniated nucleus pulposus [HNP] requiring anterior discetomy with fusion) occurred in the laminoplasty group. Multilevel corpectomy complications included progression of myelopathy, nonunion, persistent dysphagia, persistent dysphonia, and subjacent motion segment ankylosis. CONCLUSIONS: Both multilevel corpectomy and laminoplasty reliably arrest myelopathic progression in multilevel cervical myelopathy and can lead to significant neurologic recovery and pain reduction in a majority of patients. Surprisingly, the laminoplasty cohort tended to require less pain medication at final follow-up than did the multilevel corpectomy cohort. Given this and the higher prevalence of complications among multilevel corpectomy patients, it is believed that laminoplasty may be the preferred method of treatment for multilevel cervical myelopathy in the absence of preoperative kyphosis.

OBJECTIVE: The purpose of this study was to assess whether back pain is improved with surgical treatment compared with nonoperative management in adults with scoliosis. METHODS: This is a retrospective review of a prospective, multicentered database of adults with spinal deformity. At the time of enrollment and follow-up, patients completed standardized questionnaires, including the Oswestry Disability Index (ODI) and Scoliosis Research Society 22 questionnaire (SRS-22), and assessment of back pain using a numeric rating scale (NRS) score, with 0 and 10 corresponding to no and maximal pain, respectively. The initial plan for surgical or nonoperative treatment was made at the time of enrollment. RESULTS: Of 317 patients with back pain, 147 (46%) were managed surgically. Compared with patients managed nonoperatively, operative patients had higher baseline mean NRS scores for back pain (6.3 versus 4.8; P < 0.001), higher mean ODI scores (35 versus 26; P < 0.001), and lower mean SRS-22 scores (3.1 versus 3.4; P < 0.001). At the time of the 2-year follow-up evaluation, nonoperatively managed patients did not have significant change in the NRS score for back pain (P = 0.9), ODI (P = 0.7), or SRS-22 (P = 0.9). In contrast, at the 2-year follow-up evaluation, surgically treated patients had significant improvement in the mean NRS score for back pain (6.3 to 2.6; P < 0.001), ODI score (35 to 20; P < 0.001), and SRS-22 score (3.1 to 3.8; P < 0.001). Compared with nonoperatively treated patients, at the time of the 2-year follow-up evaluation, operatively treated patients had a lower NRS score for back pain (P < 0.001) and ODI (P = 0.001), and higher SRS-22 (P < 0.001). CONCLUSIONS: Despite having started with significantly greater back pain and disability and worse health status, surgically treated patients had significantly less back pain and disability and improved health status compared with nonoperatively treated patients at the time of the 2-year follow-up evaluation. Compared with nonoperative treatment, surgery can offer significant improvement of back pain for adults with scoliosis.

In Brief Study Design. Retrospective analysis of the incidence and prevalence of dysphagia after anterior cervical decompression and fusion (ACDF). Objectives. To examine the incidence and prevalence of dysphagia after ACDF, determine possible associated patient and procedural characteristics, and examine dysphagia’s impact on long-term health status and function. Summary of Background Data. Dysphagia is a common early complaint after ACDF, but the risk factors associated with its development are not understood. Methods. Telephone surveys (Cervical Spine Outcomes Questionnaire) and clinical assessments (Oswestry Neck Disability Scale and SF-36) were used to evaluate 454 patients who had undergone ACDF at one of 23 nationwide sites for individual and procedure characteristics that might contribute to dysphagia. Results. Of the 454 patients, 30% reported dysphagia at the 3-month assessment (incident cases). The incidence of new complaints of dysphagia at each follow-up point was 29.8%, 6.9%, and 6.6% at 3, 6, and 24 months, respectively. Dysphagia persisted at 6 and 24 months in 21.5% and 21.3% of patients, respectively. The risk of dysphagia increased with number of surgical vertebral levels at 3 months: 1 level, 42 of 212 (19.8%); 2 levels, 50 of 150 (33.3%); 3+ levels, 36 of 92 (39.1%). Patients reporting dysphagia at 3 months had a significantly higher self-reported disability and lower physical health status at subsequent assessments. Conclusion. Duration of preexisting pain and the number of vertebral levels involved in the surgical procedure appear to influence the likelihood of dysphagia after ACDF. We examined the occurrence of dysphagia after anterior cervical decompression with fusion in a cohort of 454 patients enrolled in the CSRS Outcomes Study. Dysphagia was common, occurring in 30% of individuals 3 months after surgery and persisting in 21% of individuals at 24 months postoperatively. Dysphagia negatively affected overall health status.

STUDY DESIGN/SETTING: Prospective, randomized, 3-center, clinical trial. OBJECTIVE: To prospectively compare the outcomes of cervical arthroplasty with the BRYAN Cervical Disc Prosthesis (Medtronic Sofamor Danek, Inc, Memphis, TN) to anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Surgical treatment of cervical disc pathology commonly involves techniques that employ discectomy and fusion (ACDF). This "gold-standard" technique has demonstrated good clinical and radiographic outcomes. Common adverse effects of this procedure are associated with the adjacent level degeneration and bone-graft harvest. Several investigators have independently reported successful short-term outcomes with the BRYAN Cervical Disc Prosthesis. In addition, a significant body of knowledge has been collected regarding the wear patterns and adjacent level effects of this device in human and animal models. METHODS: As part of an FDA IDE trial, 3 centers collected prospective outcomes data on 115 patients randomized in a 1:1 ratio to ACDF (Control group) or arthroplasty with the BRYAN Cervical Disc Prosthesis (Investigational group). RESULTS: Demographic and surgical data were generally similar in the 2 populations. Outcomes data collected at routine postoperative intervals for 24 months demonstrated that the Investigational group had statistically significant (P<0.05) improvements as assessed by the Neck Disability Index, the Neck Pain Score, and SF-36 Physical component scores. The improvement in the Mental Component Subscore values for the BRYAN and control groups was equivalent at 24 months (P=0.055). Arm pain relief was similar in both groups (P=0.152). During the course of the 2-year follow-up, 4 patients in the Control group required surgical intervention and 3 patients in the Investigational group required ACDF for adjacent level disease. CONCLUSIONS: At 24 months, cervical arthroplasty with the BRYAN Cervical Disc Prosthesis compares favorably with ACDF as defined by standard outcomes scores.

STUDY DESIGN: Retrospective review of a prospective, multicenter study. OBJECTIVE: The purpose of this study was to assess the prevalence and severity of leg pain in adults with scoliosis and to assess whether surgery significantly improved leg pain compared with nonoperative management. SUMMARY OF BACKGROUND DATA: Patients with adult scoliosis characteristically present with pain. The presence of leg pain is an independent predictor of a patient's choice for operative over nonoperative care. METHODS: Data were extracted from a prospective, multicenter database for adult spinal deformity. At enrollment and follow-up, patients complete the Oswestry Disability Index (ODI) and assessment of leg pain using the numerical rating scale (NRS) score, with 0 and 10 representing no pain and unbearable pain, respectively. Plan for operative or nonoperative treatment was made at enrollment. The vast majority of adult scoliosis patients seen in our surgical clinics have received nonoperative therapies and are being seen for a surgical evaluation. Patients are counseled regarding operative and nonoperative management options and are in general encouraged to maximize nonoperative treatments. RESULTS: Two hundred eight (64%) of 326 adults with scoliosis had leg pain at presentation (mean NRS score = 4.7). Ninety-six patients with leg pain (46%) were managed operatively and 112 were treated nonoperatively. The operative group had higher baseline mean NRS score for leg pain (5.4 vs. 4.1, P < 0.001) and higher mean ODI (41 vs. 30, P < 0.001). At 2-year follow-up, nonoperative patients had no significant change in ODI or NRS score for leg pain (P = 0.2). In contrast, at 2-year follow-up surgically treated patients had significant improvement in mean NRS score for leg pain (5.4 vs. 2.2, P < 0.001) and ODI (41 vs. 24, P < 0.001). Compared with nonsurgically treated patients, at 2-year follow-up operative patients had lower mean NRS score for leg pain (2.2 vs. 3.8, P < 0.001) and mean ODI (24 vs. 31, P = 0.005). CONCLUSION: Despite having started with significantly greater leg pain and disability, surgically treated patients at 2-year follow-up had significantly less leg pain and disability than nonoperatively treated patients. Surgical treatment has the potential to provide significant improvement of leg pain in adults with scoliosis.

Autologous cell therapies including platelet-rich plasma (PRP) and bone marrow concentrate (BMC) are increasingly popular options for soft tissue and joint-related diseases. Despite increased clinical application, conflicting research has been published regarding the efficacy of PRP, and few clinical publications pertaining to BMC are available. Preparations of PRP (and BMC) can vary in many areas, including platelet concentration, number of white blood cells, presence or absence of red blood cells, and activation status of the preparation. The potential effect of PRP characteristics on PRP efficacy is often not well understood by the treating clinician, and PRP characteristics, as well as the volume of PRP delivered, are unfortunately not included in the methods of many published research articles. It is essential to establish a standard reporting system for PRP that facilitates communication and the interpretation and synthesis of scientific investigations. Herein, the authors propose a new PRP classification system reflecting important PRP characteristics based on contemporary literature and recommend adoption of minimal standards for PRP reporting in scientific investigations. Widespread adoption of these recommendations will facilitate interpretation and comparison of clinical studies and promote scientifically based progress in the field of regenerative medicine.