Neurosurgery Resident UC Davis Sacramento, California, United States
Introduction: Headache relief after anterior cervical spine surgery has been reported. No study, however, has followed the patients out to ten years to assess the durability of headache improvement. We analyzed a select group of patients with a 10-year follow-up after single and two-level cervical disc arthroplasty (CDA) from a Food and Drug Administration (FDA) investigational device exemption (IDE) study.
Methods: We performed a post hoc analysis of patients (n=189) treated with CDA from the nine highest enrolling sites in a prospective multicenter randomized US FDA IDE clinical trial. Patients had single level (n=69) or two-level (n=120) CDA at contiguous levels from C3-C7 using Mobi-C (ZimVie, Westminster, CO). We evaluated headache scores from Neck Disability Index (NDI) headache section, along with associated demographic variables (age, gender, race, ethnicity, and body mass index). Pre-operative and 10-year post-operative headache scores were analyzed. Primary analysis was conducted via Wilcoxon rank sum testing, followed by univariate and multivariable logistic regression.
Results: After accounting for age, body mass index, race, ethnicity, and gender, there was sustained headache improvement 10-years after CDA (p=0.04). Preoperatively, median NDI was 3.00 (IQR: 1.00-4.00) and after 10-years 1.00 (IQR: 0.00-2.00), with a decrease in NDI by 1.00 (95% CI: 0.00-2.00; p=0.04). For one-level CDA, NDI was 3.00 (IQR: 1.00-4.00) preoperatively and 1.00 (IQR: 0.00-2.00) at 10-years, with an estimated 1.00 reduction in NDI (95% CI: 1.00-2.00; p< 0.0001). Two-level CDA preoperative NDI was 3.00 (IQR: 1.75-4.00) and 1.00 (IQR: 0.00-2.00) at 10-years, with an estimated 2.00 NDI reduction (95% CI: 1.00-2.00; p< 0.0001). There was no difference in headache resolution between one- and two-level CDA (p=0.90).
Conclusion : Headache relief provided by lower cervical CDA was sustained at 10-years post-operatively. There was no difference in headache improvement between one- and two-level CDA groups, or amongst BMI, gender, race, and ethnicity strata.
