Headache relief 10 years after cervical disc arthroplasty: multicenter randomized clinical trial post hoc analysis.
J Neurosurg Spine
; 40(1): 54-61, 2024 Jan 01.
Article
in En
| MEDLINE
| ID: mdl-37856387
ABSTRACT
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Spinal Fusion
/
Intervertebral Disc Degeneration
/
Total Disc Replacement
Limits:
Humans
Language:
En
Journal:
J Neurosurg Spine
Journal subject:
NEUROCIRURGIA
Year:
2024
Type:
Article