|Title||Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial.|
|Publication Type||Journal Article|
|Year of Publication||2019|
|Authors||Lavelle WF, K Riew D, Levi AD, Florman JE|
|Journal||Spine (Phila Pa 1976)|
|Date Published||2019 May 01|
|Keywords||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.
|Alternate Journal||Spine (Phila Pa 1976)|