NCT00432159

Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: DePuy Spine · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.

Detailed description

This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.

Conditions

• Cervical Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	Cervical TDR	Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
DEVICE	ACDF with plate	Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.

Timeline

• Start date: 2006-07-01
• Primary completion: 2013-05-01
• Completion: 2016-05-01
• First posted: 2007-02-07
• Last updated: 2017-10-20
• Results posted: 2014-08-07

Locations

32 sites across 3 countries: United States, Australia, Netherlands

Regulatory

• FDA-regulated device study