Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial.
Neurology and Neuroscience, Surgery
Spine (Phila Pa 1976)
Adult, Arthroplasty, Cervical Vertebrae, Diskectomy, Humans, Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Pain, Postoperative, Prostheses and Implants, Treatment Outcome, Young Adult
STUDY DESIGN: A prospective, randomized multicenter IDE trial between May 2002 and October 2004.
OBJECTIVE: The aim of this study was to report on the 10-year safety and efficacy of BRYAN cervical disc arthroplasty (CDA).
SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty (CDA) is a potential alternative for anterior cervical decompression and fusion (ACDF) with the hope that maintenance of motion may decrease the likelihood of adjacent segment disease.
METHODS: This is an analysis of a US Food and Drug Administration (FDA) investigation comparing CDA with ACDF for single-level patients. Eligible patients were ≥ 21 years of age with symptomatic cervical disc disease who had failed conservative care. Patients were followed at regular intervals with the current data set at > 10 years. Protocol for overall success: ≥ 15-point improvement in NDI scores, maintenance or improvement in neurologic status, no serious adverse events related to implant or implant/surgical procedure, and no subsequent surgery or intervention classified as "failure."
RESULTS: At 10-year follow-up, 128 (CDA) and 104 (ACDF) patients were available for evaluation. Overall success rate was significantly higher for CDA group (81.3% vs. 66.3%; P = 0.005). The rate of second surgeries at adjacent levels was lower for CDA group (9.7% vs. 15.8%; P = 0.146). NDI scores improved significantly in CDA group (Δ38.3 vs. Δ31.1; P = 0.010). Visual Analog Scale (VAS) neck and arm improved in the CDA group (Δ54.3 vs. Δ49.2; P = 0.119), (Δ58.1 vs. Δ51.6; P = 0.0.60) respectively. About 4.1% of CDA patients and 4.9% of ACDF patients had serious adverse events related to study device. Mean angular motions at index level for BRYAN disc and ACDF were 8.69° and 0.60°, respectively.
CONCLUSION: CDA can preserve and maintain motion in the long term compared with ACDF. There was a trend toward fewer adjacent segment surgeries for BRYAN disc that did not reach significance. Significant improvement in CDA NDI scores may suggest better long-term success for CDA as compared to fusion.
LEVEL OF EVIDENCE: 2.
Lavelle, William F; Riew, K Daniel; Levi, Allan D; and Florman, Jeffrey E, "Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial." (2019). Maine Medical Center. 1454.