Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00432159

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

Cervical Degenerative Disc Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00432159
Study type Interventional
Source DePuy Spine
Contact
Status Completed
Phase N/A
Start date July 1, 2006
Completion date May 1, 2016
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06383962 - Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®
Not yet recruiting NCT06413225 - Post-Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc®
Active, not recruiting NCT04469231 - The Synergy Disc To Anterior Cervical Discectomy and Fusion N/A
Completed NCT02417272 - Total Disc Replacement Versus Anterior Cervical Decompression and Fusion N/A
Completed NCT02667067 - Investigation of the Simplify® Cervical Artificial Disc N/A
Withdrawn NCT01616719 - Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease N/A
Terminated NCT00700739 - Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease Phase 4
Terminated NCT00637312 - Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study) N/A
Terminated NCT03062657 - An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine N/A
Completed NCT01106417 - Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion Phase 1/Phase 2
Completed NCT01097486 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy Phase 2
Completed NCT00637156 - Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels N/A
Completed NCT00437190 - Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF N/A
Recruiting NCT05740176 - The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery N/A
Completed NCT00667459 - Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD Phase 3
Recruiting NCT05880823 - Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc
Recruiting NCT06383949 - Real World Data Collection on the Synergy Disc
Terminated NCT01291134 - PureGen: Radiographic Analysis of Fusion for ACDF
Terminated NCT00640029 - Evaluation of the Prosthetic Disc Replacement N/A
Not yet recruiting NCT05522010 - Dynamic Cervical Implant (DCI) Versus Anterior Cervical Discectomy And Fusion(ACDF) For The Treatment Of Single-Level Cervical Degenerative Disc Disease (DDD): An RCT N/A