NCT00700739

Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease

A Multi-Centre, Prospective, Randomized, Post Marketing Surveillance Study Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Cervical Degenerative Disc Disease

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.

Detailed description

The protocol underwent 3 amendments, the last of which (02APR2009) changed the study design from a randomized to a non-randomized and non-comparative clinical trial. All of the subjects were enrolled under the randomized design with the exception of the last subject. This study is not applicable per FDAA Title VIII, Section 801 due to the final trial design. However, results are submitted to clinicaltrials.gov due to the majority of study data being collected under a randomized (FDAA Title VIII, Section 801 applicable) trial design

Conditions

• Cervical Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	DISCOVER™ Artificial Cervical Disc	DISCOVER™ Artificial Cervical Disc
DEVICE	ACDF	Cervical CFRP I/F CAGE® and SLIM LOC(R) Anterior Cervical Plate System with allograft

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-06-19
• Last updated: 2015-09-21
• Results posted: 2015-08-10

Locations

8 sites across 7 countries: Australia, Germany, Italy, Malaysia, Netherlands, Spain, United Kingdom