Abstract
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 events 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.
To investigate the adverse events rates between BRYAN CDA and ACDF.
Prospective, randomized multicenter IDE trial with surgeries performed between May 2002 and October 2004.
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.
Adverse events that occurred up to 10 years after the initial surgery.
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 events associated with CDA and ACDF were recorded. Adverse events 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 events 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.
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 events 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 events (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 events (p=0.015) and trauma (p=0.012).
The cumulative rates of patients who had any adverse events 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.
BRYAN cervical disc (Approved for this indication).