ProDisc-C total disc arthroplasty vs ACDF in single-level cervical disc disease at 7 years .
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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
J Bone Joint Surg Am. 2015 Nov 4;97(21):1738-47209 patients with single-level cervical degenerative disc disease were randomized to undergo either anterior cervical discectomy and fusion (ACDF) or total disc arthroplasty (with ProDisc-C). The purpose of this randomized controlled trial was to report the 7-year efficacy and safety outcomes of an FDA Investigational Device Exemption randomized controlled trial. The results at both 2 and 7 years postoperatively demonstrated that both procedures were effective in reducing neck and arm pain, and in improving and maintaining function and health related quality of life, with no significant differences between groups. Patient satisfaction, the rate of neurologic success, medication usage, and adverse events were similar between groups. Significantly more secondary surgical procedures were performed in the ACDF group.
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