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Clinical outcomes of BRYAN cervical disc arthroplasty: a prospective, randomized, controlled, multicenter trial with
Rick C Sasso1, Joseph D Smucker, Robert J Hacker
1Indiana Spine Group, Clinical Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, USA.
Study Design/Setting:
Prospective, randomized, 3-center, clinical trial.
Objective:
To prospectively compare the outcomes of cervical arthroplasty with the BRYAN Cervical Disc Prosthesis (Medtronic Sofamor Danek, Inc, Memphis, TN) to anterior cervical discectomy and fusion (ACDF).
Summary Of Background Data:
Surgical treatment of cervical disc pathology commonly involves techniques that employ discectomy and fusion (ACDF). This "gold-standard" technique has demonstrated good clinical and radiographic outcomes. Common adverse effects of this procedure are associated with the adjacent level degeneration and bone-graft harvest. Several investigators have independently reported successful short-term outcomes with the BRYAN Cervical Disc Prosthesis. In addition, a significant body of knowledge has been collected regarding the wear patterns and adjacent level effects of this device in human and animal models.
Methods:
As part of an FDA IDE trial, 3 centers collected prospective outcomes data on 115 patients randomized in a 1:1 ratio to ACDF (Control group) or arthroplasty with the BRYAN Cervical Disc Prosthesis (Investigational group).
Results:
Demographic and surgical data were generally similar in the 2 populations. Outcomes data collected at routine postoperative intervals for 24 months demonstrated that the Investigational group had statistically significant (P<0.05) improvements as assessed by the Neck Disability Index, the Neck Pain Score, and SF-36 Physical component scores. The improvement in the Mental Component Subscore values for the BRYAN and control groups was equivalent at 24 months (P=0.055). Arm pain relief was similar in both groups (P=0.152). During the course of the 2-year follow-up, 4 patients in the Control group required surgical intervention and 3 patients in the Investigational group required ACDF for adjacent level disease.
Conclusions:
At 24 months, cervical arthroplasty with the BRYAN Cervical Disc Prosthesis compares favorably with ACDF as defined by standard outcomes scores.
