Lindsay Tetreault, Jefferson R. Wilson, Mark R. N. Kotter, Aria Nouri, Pierre Côté, Branko Kopjar, Paul M. Arnold and Michael G. Fehlings
The minimum clinically important difference (MCID) is defined as the minimum change in a measurement that a patient would identify as beneficial. Before undergoing surgery, patients are likely to inquire about the ultimate goals of the operation and of their chances of experiencing meaningful improvements. The objective of this study was to define significant predictors of achieving an MCID on the modified Japanese Orthopaedic Association (mJOA) scale at 2 years following surgery for the treatment of degenerative cervical myelopathy (DCM).
Seven hundred fifty-seven patients were prospectively enrolled in either the AOSpine North America or International study at 26 global sites. Fourteen patients had a perfect preoperative mJOA score of 18 and were excluded from this analysis (n = 743). Data were collected for each participating subject, including demographic information, symptomatology, medical history, causative pathology, and functional impairment. Univariate log-binominal regression analyses were conducted to evaluate the association between preoperative clinical factors and achieving an MCID on the mJOA scale. Modified Poisson regression using robust error variances was used to create the final multivariate model and compute the relative risk for each predictor.
The sample consisted of 463 men (62.31%) and 280 women (37.69%), with an average age of 56.48 ± 11.85 years. At 2 years following surgery, patients exhibited a mean change in functional status of 2.71 ± 2.89 points on the mJOA scale. Of the 687 patients with available follow-up data, 481 (70.01%) exhibited meaningful gains on the mJOA scale, whereas 206 (29.98%) failed to achieve an MCID. Based on univariate analysis, significant predictors of achieving the MCID on the mJOA scale were younger age; female sex; shorter duration of symptoms; nonsmoking status; a lower comorbidity score and absence of cardiovascular disease; and absence of upgoing plantar responses, lower-limb spasticity, and broad-based unstable gait. The final model included age (relative risk [RR] 0.924, p < 0.0001), smoking status (RR 0.837, p = 0.0043), broad-based unstable gait (RR 0.869, p = 0.0036), and duration of symptoms (RR 0.943, p = 0.0003).
In this large multinational prospective cohort, 70% of patients treated surgically for DCM exhibited a meaningful functional gain on the mJOA scale. The key predictors of achieving an MCID on the mJOA scale were younger age, shorter duration of symptoms, nonsmoking status, and lack of significant gait impairment.
Abstracts of the 2013 Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves
Phoenix, Arizona • March 6–9, 2013
Michael G. Fehlings, Neilank K. Jha, Stephanie M. Hewson, Eric M. Massicotte, Branko Kopjar and Sukhvinder Kalsi-Ryan
Surgical intervention for appropriately selected patients with cervical spondylotic myelopathy (CSM) has demonstrated favorable outcomes. This study evaluates the cost-effectiveness of this type of surgery in terms of cost per quality-adjusted life year (QALY) gained.
As part of a larger prospective multicenter study, the direct costs of medical treatment for 70 patients undergoing surgery for CSM at a single institution in Canada were retrospectively obtained from the hospital expenses database and physician reimbursement data. Utilities were estimated on the entire sample of 278 subjects enrolled in the multicenter study using SF-6D–derived utilities from 12- and 24-month SF-36v2 follow-up information. Costs were analyzed from the payer perspective. A 10-year horizon with 3% discounting was applied to health-utilities estimates. Sensitivity analysis was performed by varying utility gain by 20%.
The SF-6D utility gain was 0.0734 (95% CI 0.0557–0.0912, p < 0.01) at 12 months and remained unchanged at 24 months. The 10-year discounted QALY gain was 0.64. Direct costs of medical treatment were estimated at an average of CaD $21,066. The estimated cost-utility ratio was CaD $32,916 per QALY gained. The sensitivity analysis showed a range of CaD $27,326–$40,988 per QALY gained. These estimates are within the limits for medical procedures that have an acceptable cost-utility ratio.
Surgical treatment for CSM is associated with significant improvement in health utilities as measured by the SF-6D. The direct cost of medical treatment per QALY gained places this form of treatment within the category deemed by payers to be cost-effective.
Michael G. Fehlings, Justin S. Smith, Branko Kopjar, Paul M. Arnold, S. Tim Yoon, Alexander R. Vaccaro, Darrel S. Brodke, Michael E. Janssen, Jens R. Chapman, Rick C. Sasso, Eric J. Woodard, Robert J. Banco, Eric M. Massicotte, Mark B. Dekutoski, Ziya L. Gokaslan, Christopher M. Bono and Christopher I. Shaffrey
Rates of complications associated with the surgical treatment of cervical spondylotic myelopathy (CSM) are not clear. Appreciating these risks is important for patient counseling and quality improvement. The authors sought to assess the rates of and risk factors associated with perioperative and delayed complications associated with the surgical treatment of CSM.
Data from the AOSpine North America Cervical Spondylotic Myelopathy Study, a prospective, multicenter study, were analyzed. Outcomes data, including adverse events, were collected in a standardized manner and externally monitored. Rates of perioperative complications (within 30 days of surgery) and delayed complications (31 days to 2 years following surgery) were tabulated and stratified based on clinical factors.
The study enrolled 302 patients (mean age 57 years, range 29–86) years. Of 332 reported adverse events, 73 were classified as perioperative complications (25 major and 48 minor) in 47 patients (overall perioperative complication rate of 15.6%). The most common perioperative complications included minor cardiopulmonary events (3.0%), dysphagia (3.0%), and superficial wound infection (2.3%). Perioperative worsening of myelopathy was reported in 4 patients (1.3%). Based on 275 patients who completed 2 years of follow-up, there were 14 delayed complications (8 minor, 6 major) in 12 patients, for an overall delayed complication rate of 4.4%. Of patients treated with anterior-only (n = 176), posterior-only (n = 107), and combined anterior-posterior (n = 19) procedures, 11%, 19%, and 37%, respectively, had 1 or more perioperative complications. Compared with anterior-only approaches, posterior-only approaches had a higher rate of wound infection (0.6% vs 4.7%, p = 0.030). Dysphagia was more common with combined anterior-posterior procedures (21.1%) compared with anterior-only procedures (2.3%) or posterior-only procedures (0.9%) (p < 0.001). The incidence of C-5 radiculopathy was not associated with the surgical approach (p = 0.8). The occurrence of perioperative complications was associated with increased age (p = 0.006), combined anterior-posterior procedures (p = 0.016), increased operative time (p = 0.009), and increased operative blood loss (p = 0.005), but it was not associated with comorbidity score, body mass index, modified Japanese Orthopaedic Association score, smoking status, anterior-only versus posterior-only approach, or specific procedures. Multivariate analysis of factors associated with minor or major complications identified age (OR 1.029, 95% CI 1.002–1.057, p = 0.035) and operative time (OR 1.005, 95% CI 1.002–1.008, p = 0.001). Multivariate analysis of factors associated with major complications identified age (OR 1.054, 95% CI 1.015–1.094, p = 0.006) and combined anterior-posterior procedures (OR 5.297, 95% CI 1.626–17.256, p = 0.006).
For the surgical treatment of CSM, the vast majority of complications were treatable and without long-term impact. Multivariate factors associated with an increased risk of complications include greater age, increased operative time, and use of combined anterior-posterior procedures.