ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study.

Abstract

BACKGROUND:

In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7.

METHODS:

Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106). Patients were assessed preoperatively; at six weeks and three, six, twelve, eighteen, and twenty-four months postoperatively; and then annually until seven years postoperatively. Outcome measures included the Neck Disability Index (NDI), the Short Form-36 (SF-36), postoperative neurologic parameters, secondary surgical procedures, adverse events, neck and arm pain, and satisfaction scores.

RESULTS:

At seven years, the overall follow-up rate was 92% (152 of 165). There were no significant differences in demographic factors, follow-up rate, or patient-reported outcomes between groups. Both procedures were effective in reducing neck and arm pain and improving and maintaining function and health-related quality of life. Neurologic status was improved or maintained in 88% and 89% of the patients in the ProDisc-C and ACDF groups, respectively. After seven years of follow-up, thirty secondary surgical procedures had been performed in nineteen (18%) of 106 patients in the ACDF group compared with seven secondary surgical procedures in seven (7%) of 103 patients in the ProDisc-C group (p = 0.0099). There were no significant differences in the rates of any device-related adverse events between the groups.

CONCLUSIONS:

Total disc arthroplasty with ProDisc-C is a safe and effective surgical treatment of single-level symptomatic cervical degenerative disc disease. Clinical outcomes after total disc arthroplasty with ProDisc-C were similar to those after ACDF. Patients treated with ProDisc-C had a lower probability of subsequent surgery, suggesting that total disc arthroplasty provides durable results and has the potential to slow the rate of adjacent-level disease.

LEVEL OF EVIDENCE:

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

• Authors: Michael E Janssen, Jack E Zigler, Jeffrey M Spivak, Rick B Delamarter, Bruce V Darden 2nd, Branko Kopjar
• Journal: The Journal of bone and joint surgery. American volume (J Bone Joint Surg Am) Vol. 97 Issue 21 Pg. 1738-47 (Nov 04 2015) ISSN: 1535-1386 [Electronic] United States
• PMID: 26537161 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

Topics

• Adult
• Cervical Vertebrae
• Device Approval
• Diskectomy
• Female
• Follow-Up Studies
• Humans
• Intervertebral Disc Degeneration (surgery)
• Male
• Middle Aged
• Product Surveillance, Postmarketing
• Prospective Studies
• Prostheses and Implants
• Spinal Fusion
• Time Factors
• Total Disc Replacement
• Treatment Outcome
• United States