Status:
COMPLETED
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
Lead Sponsor:
DePuy Spine
Conditions:
Cervical Degenerative Disc Disease
Eligibility:
All Genders
21-70 years
Phase:
NA
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 ...
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....
Eligibility Criteria
Inclusion
- Key
- Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
- Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
- Moderate Neck Disability Index (NDI) score
- Able to give informed consent for study participation
- Able and willing to return for all follow-up visits
- Key
Exclusion
- Significant cervical degenerative disc disease
- Prior fusion procedure at any level(s) (C1-T1)
- Marked cervical instability on lateral or flexion/extension radiographs
- Presence of systemic infection or infection at the surgical site
- Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- History of alcohol and/or drug abuse
- Any known allergy to a metal alloy or polyethylene
- Morbid obesity
- Any significant general illness (e.g., metastatic cancer, HIV)
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00432159
Start Date
July 1 2006
End Date
May 1 2016
Last Update
October 20 2017
Active Locations (32)
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1
Olympia Medical Center
Beverly Hills, California, United States, 90211
2
Sutter Medical Center
Sacramento, California, United States, 95816
3
Rocky Mountain Associates in Orthopedic Medicine, PC
Loveland, Colorado, United States, 80538
4
Yale University
New Haven, Connecticut, United States, 06520