Seven-Year Reoperation Rates: Results of a Prospective Randomized Clinical Trial: Cervical Total Disc Replacement Versus Fusion

OBJECTIVE Cervical total disc replacement (TDR) has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative disc disease. In addition to preserving motion, evidence suggests that cervical TDR may result in a lower incidence of subsequent surgical intervention than treatment with fusion. The goal of this study was to evaluate subsequent surgery rates up to 5 years in patients treated with TDR or ACDF at 1 or 2 contiguous levels between C-3 and C-7. METHODS This was a prospective, multicenter, randomized, unblinded clinical trial. Patients with symptomatic degenerative disc disease were enrolled to receive 1- or 2-level treatment with either TDR as the investigational device or ACDF as the control treatment. There were 260 patients in the 1-level study (179 TDR and 81 ACDF patients) and 339 patients in the 2-level study (234 TDR and 105 ACDF patients). RESULTS At 5 years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for 1-level (TDR, 4.5% [8/179]; ACDF, 17.3% [14/81]; p = 0.0012) and 2-level (TDR, 7.3% [17/234]; ACDF, 21.0% [22/105], p = 0.0007) treatment. The TDR group demonstrated significantly fewer index- and adjacent-level subsequent surgeries in both the 1- and 2-level cohorts. CONCLUSIONS Five-year results showed treatment with cervical TDR to result in a significantly lower rate of subsequent surgical intervention than treatment with ACDF for both 1 and 2 levels of treatment. Clinical trial registration no.: NCT00389597 (clinicaltrials.gov)

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Influence of Adverse Events on Clinical Outcomes of Patients in an FDA IDE Clinical Trial of Cervical Total Disc Replacement versus Anterior Cervical Discectomy and Fusion

The Spine Journal ◽

10.1016/j.spinee.2015.07.261 ◽

2015 ◽

Vol 15 (10) ◽

pp. S195-S196

Author(s):

Donna D. Ohnmeiss ◽

Hyun W. Bae

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Clinical Outcomes ◽

Total Disc Replacement ◽

Anterior Cervical Discectomy ◽

Disc Replacement ◽

Cervical Total Disc Replacement ◽

Cervical Discectomy

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Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

Journal of Neurosurgery Spine ◽

10.3171/2015.12.spine15824 ◽

2016 ◽

Vol 25 (2) ◽

pp. 213-224 ◽

Cited By ~ 57

Author(s):

Kris Radcliff ◽

Domagoj Coric ◽

Todd Albert

Keyword(s):

Clinical Trial ◽

Outcome Measures ◽

Total Disc Replacement ◽

Disc Replacement ◽

Adverse Event Rate ◽

Cervical Disc ◽

Long Term Outcome ◽

Cervical Total Disc Replacement ◽

Investigational Device Exemption ◽

Disease Specific

OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor. RESULTS A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups. CONCLUSIONS Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 (clinicaltrials.gov)

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