Citations

Study Design: A national prospective cervical spine surgery registry was developed to archive radiographic studies, patient-reported outcome measures (PROMs), and surgical implant data to assess long-term safety. Objective: To describe the design, development, funding, and implementation of a cervical spine data registry for 1000 patients with myelopathy and radiculopathy. Summary of Background Data: While surgery for cervical radiculopathy and myelopathy is safe and effective, there is significant practice variation among spine surgeons. While randomized clinical trials (RCTs) can provide high-quality comparative effectiveness data, RCTs lack the ability to evaluate the safety and effectiveness of various surgical procedures and implants among heterogenous real-world patient populations. The CSRS Registry was designed to collect patient demographics, outcomes, radiographic imaging, surgical approach, and implant data for the purpose of conducting high-quality research. Methods: Patients with cervical myelopathy or radiculopathy were enrolled in the CSRS National Registry. De-identified patient data, validated PROMs, radiographic data, and implant data were collected from multiple clinical sites across the United States. Results: One thousand patients [mean age, 58 y; 456 (46%) women] were enrolled, with 31% follow-up at 1 year. Five hundred ninety-two patients were diagnosed with radiculopathy, 252 with myelopathy, and 156 with radiculopathy and myelopathy. Patients had significant improvements in their PROMs after surgery. At 1 year, the mean NDI score improved from 37.2 to 20.9 ( P <0.001). The mean self-reported P-mJOA score at baseline was 14.2 and improved to 15.2 by 1 year ( P <0.001). Baseline CSDI score was 23.6 and improved with a 1-year decrease to an average score of 13.6 ( P <0.001). There was significant improvement in PROMIS-10 Physical Health score from 41.0 to 45.9 (n=311; P <0.001) at 1-year follow-up. Conclusions: The CSRS Registry has successfully collected clinical outcomes data that is being leveraged for comparative effectiveness research and evaluations of the long-term safety and effectiveness of spinal implants.

Importance The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery. Objective To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM. Design, Setting, and Participants This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023. Intervention Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery. Main Outcomes and Measures The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE). Results Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, −0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007). Conclusions and Relevance In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.

Study Design. Retrospective cohort study of prospectively accrued data. Objective. To evaluate a large, prospective, multicentre dataset of surgically treated degenerative cervical myelopathy (DCM) cases on the contemporary risk of C5 palsy with surgical approach. Summary of Background Data. The influence of surgical technique on postoperative C5 palsy after decompression for DCM is intensely debated. Comprehensive, covariate-adjusted analyses are needed using contemporary data. Methods. Patients with moderate to severe DCM were prospectively enrolled in the multicenter, randomized, Phase III CSM-Protect clinical trial and underwent either anterior or posterior decompression between Jan 31, 2012 and May 16, 2017. The primary outcome was the incidence of postoperative C5 palsy, defined as the onset of muscle weakness by at least one grade in manual muscle test at the C5 myotome with slight or absent sensory disruption after cervical surgery. Two comparative cohorts were made based on the anterior or posterior surgical approach. Multivariate hierarchical mixed-effects logistic regression was used to estimate odds ratios (OR) with 95% confidence intervals (CI) for C5 palsy. Results. A total of 283 patients were included, and 53.4% underwent posterior decompression. The total incidence of postoperative C5 palsy was 7.4% and was significantly higher in patients who underwent posterior decompression compared with anterior decompression (11.26% vs. 3.03%, P=0.008). After multivariable regression, the posterior approach was independently associated with greater than four times the likelihood of postoperative C5 palsy (P=0.017). Rates of C5 palsy recovery were comparable between the two surgical approaches. Conclusion. The odds of postoperative C5 palsy are significantly higher after posterior decompression compared to anterior decompression for DCM. This may influence surgical decision-making when there is equipoise in deciding between anterior and posterior treatment options for DCM. Level of Evidence. Therapeutic Level—II

BACKGROUND: Anterior approaches to the cervical spine are among the most common exposures by which neurosurgeons and orthopedic surgeons access the prevertebral space and ultimately the cervical disk and vertebral bodies. There is a paucity of literature describing the microanatomic fascial planes of the neck with respect to anterior cervical approaches. OBJECTIVE: To delineate the microanatomic connections of the cervical fascial planes pertinent to anterior cervical exposure. METHODS: Using a cadaveric model, original illustrations, the Visible Human Project, and an original surgical video, we demonstrate a stepwise method for identifying the correct planes for anterior cervical exposure. RESULTS: A step-by-step method for identifying the anterior cervical fascial planes intraoperatively is demonstrated. CONCLUSION: A comprehensive understanding of anterior cervical microsurgical anatomy is vital for performing a methodical yet efficient approach to the prevertebral space while minimizing retraction and iatrogenic injury to the surrounding neurovascular structures.

Study Design: Literature review. Objectives: Surgical site infection (SSI) following spine surgery leads to significant patient morbidity, mortality, and increased health care costs. The purpose of this article is to identify risk factors and strategies to prevent SSIs following spine surgery, with particular focus on avoiding infections in posterior cervical surgery. Methods: We performed a literature review and synthesis to identify methods that can be used to prevent the development of SSI following spine surgery. Specific pearls for preventing infection in posterior cervical spine surgery are also presented. Results: SSI prevention can be divided into patient and surgeon factors. Preoperative patient factors include smoking cessation, tight glycemic control, weight loss, and nutrition optimization. Surgeon factors include screening and treatment for pathologic microorganisms, skin preparation using chlorhexidine and alcohol, antimicrobial prophylaxis, hand hygiene, meticulous surgical technique, frequent irrigation, intrawound vancomycin powder, meticulous multilayered closure, and use of closed suction drains. Conclusion: Prevention of SSI following spine surgery is multifactorial and begins with careful patient selection, preoperative optimization, and meticulous attention to numerous surgical factors. With careful attention to various patient and surgeon factors, it is possible to significantly reduce SSI rates following spine surgery.

Study Design: Retrospective multicenter case series. Objective: To assess the rate of perioperative vision loss following cervical spinal surgery. Methods: Medical records for 17 625 patients from 21 high-volume surgical centers from the AOSpine North America Clinical Research Network who received cervical spine surgery (levels from C2 to C7) between January 1, 2005, and December 31, 2011, inclusive, were reviewed to identify occurrences of vision loss following surgery. Results: Of the 17 625 patients in the registry, there were 13 946 patients assessed for the complication of blindness. There were 9591 cases that involved only anterior surgical approaches; the remaining 4355 cases were posterior and/or circumferential fusions. There were no cases of blindness or vision loss in the postoperative period reported during the sampling period. Conclusions: Perioperative vision loss following cervical spinal surgery is exceedingly rare.

Study Design: Systematic review and meta-analysis. Objectives: The safety of new technology such as cervical total disc replacement (TDR) is of paramount importance and is best evaluated in randomized clinical trials (RCT). We compared complication risks of TDR to fusion using data from Investigational Device Exemptions. Methods: A systematic review of FDA Summary of Safety and Effectiveness reports of the 8 approved cervical TDRs was performed. These were all randomized controlled trials comparing anterior cervical discectomy and fusion (ACDF) to TDR. Important outcome variables were dysphagia, wound infection, neurologic injuries, heterotopic ossification, death, and secondary surgeries. A random effects model was selected a priori. Data on adverse events was abstracted and analyzed by calculating relative risk of ACDF to TDR by meta-analysis techniques. Results: The study included 3027 patients with 1377 randomized to ACDF and 1652 to TDR. No statistical differences were present between the 2 groups in dysphagia/dysphonia, hardware related, heterotopic ossification, death, and overall neurologic adverse events and incidence of neurologic deterioration. The relative risk of wound-related problems ACDF to TDR was 0.76 (95% confidence interval [CI] = 0.59, 0.98) favoring ACDF, which was statistically significant, but these were minor and never required a second surgical procedure for deep wound infection. The relative risk of ACDF to TDR in surgical-related neurologic events and secondary surgeries was 1.62 (95% CI = 1.04, 2.53) and 1.79 (95% CI = 1.17, 2.74), both favoring TDR. Conclusions: Cervical TDR appears to be as safe as or safer than ACDF at 2-year follow-up.

Study Design: Multicenter retrospective case series. Objective: To determine the rate of thoracic duct injury during cervical spine operations. Methods: A retrospective case series study was conducted among 21 high-volume surgical centers to identify instances of thoracic duct injury during anterior cervical spine surgery. Staff at each center abstracted data for each identified case into case report forms. All case report forms were collected by the AOSpine North America Clinical Research Network Methodological Core for data processing, cleaning, and analysis. Results: Of a total of 9591 patients reviewed that underwent cervical spine surgery, 2 (0.02%) incurred iatrogenic injury to the thoracic duct. Both patients underwent a left-sided anterior cervical discectomy and fusion. The interruption of the thoracic duct was addressed intraoperatively in one patient with no residual postoperative effects. The second individual developed a chylous fluid collection approximately 2 months after the operation that required drainage via needle aspiration. Conclusions: Damage to the thoracic duct during cervical spine surgery is a relatively rare occurrence. Rapid identification of the disruption of this lymphatic vessel is critical to minimize deleterious effects of this complication.

Study Design: A multicenter, retrospective review of C5 palsy after cervical spine surgery. Objective: Postoperative C5 palsy is a known complication of cervical decompressive spinal surgery. The goal of this study was to review the incidence, patient characteristics, and outcome of C5 palsy in patients undergoing cervical spine surgery. Methods: We conducted a multicenter, retrospective review of 13 946 patients across 21 centers who received cervical spine surgery (levels C2 to C7) between January 1, 2005, and December 31, 2011, inclusive. P values were calculated using 2-sample t test for continuous variables and χ 2 tests or Fisher exact tests for categorical variables. Results: Of the 13 946 cases reviewed, 59 patients experienced a postoperative C5 palsy. The incidence rate across the 21 sites ranged from 0% to 2.5%. At most recent follow-up, 32 patients reported complete resolution of symptoms (54.2%), 15 had symptoms resolve with residual effects (25.4%), 10 patients did not recover (17.0%), and 2 were lost to follow-up (3.4%). Conclusion: C5 palsy occurred in all surgical approaches and across a variety of diagnoses. The majority of patients had full recovery or recovery with residual effects. This study represents the largest series of North American patients reviewed to date.