Clinical outcomes of Bryan cervical disc arthroplasty a prospective, randomized, controlled, single site trial with 48-month follow-up.

STUDY DESIGN

Prospective, randomized, controlled. Level 1 evidence.

OBJECTIVE

To report functional outcomes at 48 months follow-up on prospectively randomized patients to either the Bryan cervical disc prosthesis or anterior cervical discectomy and fusion (ACDF) at a single site.

SUMMARY OF BACKGROUND DATA

Surgical treatment of cervical disc pathology can involve discectomy and fusion (ACDF), the gold standard technique. The safety and effectiveness of this procedure has been established and demonstrated in the literature, however, limitations have evolved and alternatives such as disc replacement are being investigated. Intervertebral disc replacement is designed to preserve motion, both at affected and adjacent levels avoiding limitations of fusion such as adjacent level degeneration. New onset degenerative changes and possible recurring neurologic symptoms may be deferred or eliminated with cervical disc replacement. A recent multicenter trial with 24 months follow-up has shown the Bryan disc to compare favorably with ACDF. Continued follow-up is needed to further evaluate and compare functional outcomes in both these cohorts.

METHODS

A total of 47 patients were enrolled at our site as part of an ongoing multicenter prospectively randomized study investigating ACDF versus Bryan cervical disc prosthesis. Functional outcomes are now reported at 48 months follow-up for our cohort of participants. Neck disability index score (NDI), VAS neck and arm and SF-36 both physical and mental as well as complications and reoperations will be reported.

RESULTS

Functional outcome data collected at routine follow-up for 48-months has favorably demonstrated improved functional outcomes for NDI, neck/arm pain VAS scores, and the SF-36 physical/mental health component scores for the Bryan arthroplasty and ACDF cohorts. The NDI scores for the Bryan arthroplasty preoperatively was 51 and at 48 months 10. For ACDF preoperative NDI score was also 51 and at 48 months 16.7. At 48 months NDI success, measured by >or=15 points NDI improvement demonstrated a 93.3% success for Bryan arthroplasty and an 82.4% success for ACDF. VAS neck pain scores for the Bryan arthroplasty preoperatively was 76.2 and at 48 months was 13.6. VAS neck pain scores for ACDF preoperatively was 80.6 and at 48 months was 28.1. Arm Pain scores were also measured and for the Bryan arthroplasty preoperatively measured 78.8 and at 48 months 10.8. For ACDF arm pain scores preoperatively measured 77.1 and at 48 months 21.7. These outcomes have not been associated with any degradation of outcome measures from 2 to 4 years. During the 48 months of follow-up at our institution we also report 6 secondary surgeries in our control group (ACDF) and only 1 in our investigational group (Bryan). Of the 6 surgeries in the control group performed, 3 or 12% to date were for adjacent level degenerative disease and 1 or 4% for remote level degenerative disc disease. The remaining 2 surgeries were performed on the same patient for a pseudarthrosis. In the investigational group there was only 1 secondary surgery performed to date for adjacent level disease 5%.

CONCLUSIONS

At 48 months, cervical arthroplasty with the Bryan cervical disc prosthesis continues to compare favorably to ACDF at our institution. There has been no degradation of functional outcomes from 24 to 48 months for NDI, VAS of neck and arm, and SF-36. There has been a lower incidence of secondary surgeries for the Bryan arthroplasty cohort to date.