117. Ten-year BRYAN cervical disc arthroplasty: does change in angular motion have an effect on changes in patient-reported outcomes?

Abstract

BACKGROUND CONTEXT Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion with the added potential benefit of maintaining angular motion. The BRYAN cervical disc has been studied with over 10 years of data currently reported. PURPOSE The purpose of the study was to report the correlation between change in range of motion (ROM) and change in patient-reported outcomes. STUDY DESIGN/SETTING This was a prospective, randomized multicenter Investigational Device Exemption (IDE) trial with surgeries performed between May 2002 and October 2004. A 10-year analyses of patient-reported outcomes, using BRYAN cervical disc arthroplasty at a single level, was performed. PATIENT SAMPLE A total of 242 patients received BRYAN CDA (110=male, and 132=female). OUTCOME MEASURES Using Neck Disability Index (NDI), neck pain and arm pain scores and ROM to determine the correlation between change in ROM and change in patient-reported clinical outcomes. METHODS Eligible patients were ≥21 years of age with symptomatic cervical disc disease who had failed conservative care for at least 6 weeks. We documented patients preoperative and postoperative follow-ups completed at regular intervals; clinical outcomes (NDI, neck pain and arm pain); and ROM were used for analysis. A correlation analysis was done, between change in ROM from preoperative to postoperative (regular follow-ups) and change in clinical outcomes from preoperative to postoperative. The analysis was performed using the Pearson correlation coefficient. RESULTS A total of 242 patients received BRYAN CDA (110=male, and 132=female) with a mean age of 44.4 years. There was no significant difference in the mean of ROM from preoperative (6.54°) to 3-month postoperative (6.3°). However, the mean change of ROM, from preoperative to all visits after 3 months, was statistically significant throughout the follow-up at 10 years with the mean change of ROM at the 10-year follow-up being 2.1° and the mean of ROM being 8.69°. NDI, neck pain and arm pain scores improved significantly by 38.3, 54.3 and 58.1 (p CONCLUSIONS The ROM did not change significantly; however, NDI, neck and arm pain scores improved significantly after 3 months postoperatively. ROM was maintained and clinical outcomes were further improved in the follow-ups. The change in range of motion had no effect on change in clinical outcomes. With 10 years of data, there was no meaningful correlation between change in range of motion and change in patient reported clinical outcomes with BRYAN cervical disc arthroplasty. FDA DEVICE/DRUG STATUS BRYAN cervical disc (Approved for this indication).