Wednesday, September 26, 2018 3:35 PM – 5:05 PM Preserving Spinal Motion: 84. Ten-year adverse events after randomization to BRYAN cervical disc arthroplasty versus anterior cervical discectomy and fusion

Abstract

BACKGROUND CONTEXT Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential benefit of an early return toward unrestricted activities. However, the long-term adverse of arthroplasty are yet to be fully reported. A 10-year experience with the BRYAN disc arthroplasty trial provides the opportunity to report adverse events. PURPOSE To investigate the adverse rates between BRYAN CDA and ACDF. STUDY DESIGN/SETTING Prospective, randomized multicenter IDE trial with surgeries performed between May 2002 and October 2004. PATIENT SAMPLE A total of 242 patients received BRYAN CDA (110=male, and 132=female) with a mean age 44.4 years; 221 patients received ACDF (113=male, and 108=female) with a mean age of 44.7 years. OUTCOME MEASURES Adverse that occurred up to 10 years after the initial surgery. METHODS A 10-year analysis of outcomes following FDA investigation of patients randomized to the BRYAN cervical disc arthroplasty versus fusion at a single level was performed. Patients were followed at regular intervals and adverse associated with CDA and ACDF were recorded. Adverse included: cancer, cardiovascular, carpal tunnel syndrome, death, dysphagia or dysphonia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, non-union, spinal events, other events, other pain and intraoperative vascular injury. Other events consisted of various that did not fit into another category, such as rash, depression, or hypertension. Each adverse event was compared between groups for the cumulative rate up to 10 years. Time to event analysis with a log-rank test was used for analysis. RESULTS At up to 10 years of follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event (p=0.166). The cumulative rates of the following adverse were not different between the two groups for cancer (p=.860), cardiovascular (p=.653), death (p=.507), dysphonia/dysphagia (p=.341), gastrointestinal (p=.389), infection (p=.669), urogenital (p=.873), respiratory (p=.984), implant displacement/loosening (p=.200), implant malposition (p=0.179), neck and arm pain (p=.411), neurological (p=.888), other pain (p=.147), spinal (p=.792), urogenital (p=0.873) and intraoperative vascular injury (p=.583). However, the cumulative rates were different between the CDA and ACDF groups for non-union (p=.019), other (p=0.015) and trauma (p=0.012). CONCLUSIONS The cumulative rates of patients who had any adverse were not different between BRYAN artificial cervical disc and the anterior cervical arthrodesis group. In addition, the cumulative rates were not different between the two groups for the majority of categories as well. FDA DEVICE/DRUG STATUS BRYAN cervical disc (Approved for this indication).