Headache relief 10 years after cervical disc arthroplasty: multicenter randomized clinical trial post hoc analysis

OBJECTIVE Headache relief after anterior cervical spine surgery has been reported. No study, however, has followed patients out to 10 years to assess the durability of headache improvement. The authors analyzed a group of patients with a 10-year follow-up after one- or two-level cervical disc arthroplasty (CDA) from an FDA investigational device exemption (IDE) study. METHODS The authors performed a post hoc analysis of 189 patients treated with CDA from the 9 highest enrolling sites in a prospective multicenter randomized US FDA IDE clinical trial. Patients had one- or two-level CDA at contiguous levels from C3 to C7 using the Mobi-C device. The authors evaluated headache scores from the headache section of the Neck Disability Index (NDI), along with associated demographic variables (age, sex, race, ethnicity, and BMI). Preoperative and 10-year postoperative headache scores were analyzed. Primary analysis was conducted via the Wilcoxon rank-sum test, followed by univariate and multivariable logistic regression. RESULTS After accounting for age, BMI, race, ethnicity, and sex, there was sustained headache improvement 10 years after CDA (p = 0.04). Preoperatively, the median NDI score was 3.00 (IQR 1.00–4.00) and after 10 years it was 1.00 (IQR 0.00–2.00), with a decrease in the NDI score by 1.00 point (95% CI 0.00–2.00, p = 0.04). For one-level CDA, the median NDI score was 3.00 (IQR 1.00–4.00) preoperatively but 1.00 (IQR 0.00–2.00) at 10 years, with an estimated reduction in the NDI score of 1 point (95% CI 1.00–2.00, p < 0.0001). For two-level CDA, the median NDI score was 3.00 (IQR 1.75–4.00) preoperatively and 1.00 (IQR 0.00–2.00) at 10 years, with an estimated reduction in the NDI score of 1 point (95% CI 1.00–2.00, p < 0.0001). CONCLUSIONS Headache relief provided by cervical CDA, for symptomatic C3–7 cervical spondylosis, was sustained even 10 years after surgery. There was no difference in headache improvement between the one- and two-level CDA groups, or among BMI, sex, race, and ethnicity strata.