74. Cervical disc arthroplasty for axial neck pain: outcomes up to seven years

Abstract BACKGROUND Short- and mid-term studies have shown the effectiveness of cervical disc arthroplasty (CDA) to treat cervical disc degeneration. OBJECTIVE To report the 10-yr outcomes of a multicenter experience with cervical arthroplasty for 1- and 2-level pathology. METHODS This was a prospective study of patients treated with CDA at 1 or 2 contiguous levels using the Mobi-C® Cervical Disc (Zimmer Biomet). Following completion of the 7-yr Food and Drug Administration postapproval study, follow-up continued to 10 yr for consenting patients at 9 high-enrolling centers. Clinical and radiographic endpoints were collected out to 10 yr. RESULTS At 10 yr, patients continued to have significant improvement over baseline Neck Disability Index (NDI), neck and arm pain, neurologic function, and segmental range of motion (ROM). NDI and pain outcomes at 10 yr were significantly improved from 7 yr. Segmental and global ROM and sagittal alignment also were maintained from 7 to 10 yr. Clinically relevant adjacent segment pathology was not significantly different between 7 and 10 yr. The incidence of motion restricting heterotopic ossification at 10 yr was not significantly different from 7 yr for 1-level (30.7% vs 29.6%) or 2-level (41.7% vs 39.2%) patients. Only 2 subsequent surgeries were reported after 7 yr. CONCLUSION Our results through 10 yr were comparable to 7-yr outcomes, demonstrating that CDA with Mobi-C continues to be a safe and effective surgical treatment for patients with 1- or 2-level cervical degenerative disc disease.

Download Full-text

174 Comparison of 7-Year Results of One-Level versus Two-Level Cervical Disc Arthroplasty and Fusion

Neurosurgery ◽

10.1093/neuros/nyx417.174 ◽

2017 ◽

Vol 64 (CN_suppl_1) ◽

pp. 245-245

Author(s):

Todd H Lanman

Keyword(s):

Clinical Trials ◽

Neck Pain ◽

Cervical Disc ◽

Cervical Disc Arthroplasty ◽

Propensity Score Method ◽

Disc Disease ◽

Disc Arthroplasty ◽

Arm Pain ◽

Sf 36 ◽

Level Versus

Abstract INTRODUCTION Two independent clinical trials concluded that cervical disc arthroplasty (CDA) is as safe and effective as anterior cervical discectomy and fusion (ACDF) for treating cervical disc disease (CDD) at one and two levels. This study compared the safety and effectiveness at 7-year follow-up for subjects treated with CDA versus ACDF at 1 and 2-levels. METHODS Retrospective analysis of combined data from 1 and 2-level FDA IDE clinical trials. Outcomes were compared between 1-level and 2-level CDA and ACDF subjects. Propensity score method was used for an adjusted means analysis. RESULTS >There were no preoperative differences between 1 and 2-level CDA and ACDF patients for NDI, neck/arm pain, and SF-36 PCS. Comparing 1 vs 2-level CDA: there were no differences between 1 and 2-level CDA for NDI improvement (38.2 vs 39.0, P = 0.768), neck pain (11.7 vs 12.3, P = 0.374), arm pain (11.3 vs 11.0, P = 0.736), SF-36 PCS (12.6 vs 14.5, P = 0.220), or rates of neurological success (92.8% vs 91.6%, P = 0.867). Secondary surgeries were numerically higher for 1-than 2-level CDA at index and adjacent levels (7.3% vs 4.2%, P = 0.566) and (11.6% vs 6.5%, P = 0.056) respectively. Rates of serious AEs were significantly higher for 1 than 2-level CDA (67.8% vs 56.7%, P = 0.004). Comparison of 1 vs 2-level ACDF: there were no differences between 1 and 2-level ACDF for NDI improvement (31.1 vs 31.6, P = 0.859), neck pain (9.7 vs 9.9, P = 0.796), arm pain (9.9 vs 10.1, P = 0.848), SF-36 PCS (10.8 vs 12.1, P = 0.424), rates of neurological success (79.7% vs 82.1%, P = 0.421), or rates of secondary surgeries at index levels (13.6% vs 14.7%, P = 0.631) or adjacent levels (10.9% vs 12.5%, P = 0.366). Rates of serious AEs were similar for 1 and 2-level ACDF (61.8% vs 68.2%, P = 0.200) but rates of all AEs (94.5% vs 98.2%, P < 0.001) and device-related AEs (18.9% vs. 27.7%, P = 0.036) were significantly lower for 1 versus 2-level ACDF. CONCLUSION One and 2-level CDA appear to be equally safe and effective in the treatment of CDD at 7-years. Two-level ACDF was equally effective as 1-level, but 2-level ACDF had a higher rate of device-related AEs.

Download Full-text