Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc

Abstract

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

Midterm osteolysis-induced aseptic failure of the M6-C™ cervical total disc replacement secondary to polyethylene wear debris

“…According to these meta-analyses, CTDR seems to be superior to ACDF with regard to most clinical parameters [14,15]. Given the short-term clinical success of CTDR around the world, criticisms in the literature regarding long-term durability of these prostheses resulted in publications of midterm results [16][17][18].…”

Financial Aspects of Cervical Disc Arthroplasty: A Narrative Review of Recent Literature

“…5,6,9,[11][12][13][14][15] Additionally, long-term follow-up studies have demonstrated favorable results of arthroplasty, particularly in terms of pain, disability, neurological status and patient satisfaction. [16][17][18][19][20][21][22] Moreover, past studies have also reported decreased rates of radiographic adjacent segment degeneration and symptomatic adjacent segment disease after CDA compared to ACDF. [11][12][13]17,[23][24][25][26][27] Although these studies have described encouraging results, some reports have noted limitations with generalizability, and elevated risks of selection bias due to the initial industrysponsored trials' strict inclusion and exclusion criteria.…”

“…10,28 In terms of revision and readmission rates, CDA appears to perform similarly, if not better, than ACDF. 17,[21][22][23][24]26,29,30 While some studies have demonstrated decreased rates of reoperation at the adjacent level after CDA, Kelly and colleagues noted no significant difference in secondary surgery when comparing arthroplasty to ACDF up to 5-year follow-up. [21][22][23]29 Similarly, Bhashyam et al reported no significant differences with reoperation rates between ACDF and CDA.…”

Comparison of the Safety of Outpatient Cervical Disc Replacement With Inpatient Cervical Disc Replacement: A Systematic Review and Meta-Analysis

“…[2][3][4] Randomized controlled studies (RCTs) also demonstrated that CDR could prevent adjacent segment degeneration (ASD) compared with ACDF. [5][6][7] Therefore, CDR has become an important option for the treatment of CDDD.…”