Thursday, September 27, 2018 3:35 PM–5:05 PM Section on Motion Technology Abstract Presentations: 133. Cervical disc arthroplasty: 10-year results

Abstract

BACKGROUND CONTEXT Level I evidence from FDA IDE studies of multiple devices supports cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion for appropriately selected patients. Long-term outcomes following CDA continue to be assessed. PURPOSE This reports the 10-year postoperative outcomes of CDA. STUDY DESIGN/SETTING Single-arm follow-up of the investigational group from a prospective, multicenter FDA IDE trial (postapproval study of clinicaltrials.gov: NCT00667459). PATIENT SAMPLE A total of 280 patients with single-level cervical disc disease with radiculopathy and/or myelopathy treated with CDA. OUTCOME MEASURES The primary endpoint was overall success, a composite variable that included five criteria: 1) Neck Disability Index (NDI) score improvement of ≥15 points; 2) maintenance or improvement in neurological status; 3) anterior nor posterior disc height declined by no more than 2 mm compared to 6-week postoperative; 4) no serious adverse event caused by the implant or by both the implant and surgical procedure; and 5) no additional surgery classified as failure. Additional safety and effectiveness endpoints included NDI, neck pain and arm pain numerical rating scales, SF-36, patient satisfaction, range of motion (ROM) and adverse events (AE). METHODS Clinical and radiographic assessments were performed preoperatively, intraoperatively, and postoperatively out to 10 years. RESULTS Follow up was 90.6% at 10 years; overall success rates (without disc height) remained stable at 74.3%. Preoperative, 7-year, and 10-year postoperative scores were as follows: NDI: 55.5±14.7, 15.1±19.8, 15.0±17.8; neck pain: 67.0±20.8, 12.0±22.1, 11.2±19.6; arm pain: 59.6±26.3, 8.8±18.0, 8.5±17.2; SF-36 PCS: 32.2±7.4, 45.6±11.7, 44.5±12.3, SF-36 MCS: 44.5±11.5, 52.9±9.7, 52.4±9.7. All improvements from preoperative to 7 and 10 years postoperative were statistically significant (p CONCLUSIONS CDA remained safe and effective out to 10 years postoperatively. Significant long-term patient-reported and neurological outcomes improvements from baseline were consistent with previous reports, with few additional serious AEs or secondary surgeries. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.