Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT00432159
Brief 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.
Study:
NCT00432159
Study Brief:
Protocol Section:
NCT00432159