Status:
COMPLETED
Cervical I/F Cage for Anterior Cervical Fusion
Lead Sponsor:
DePuy Spine
Conditions:
Cervical Intervertebral Disc Degeneration
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with stan...
Detailed Description
This is a prospective randomized multi-center clinical trial to assess the safety and efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent levels of the cervical...
Eligibility Criteria
Inclusion
- Persistent recurrent neck and/or shoulder and arm pain refractory to 6 weeks of non-surgical therapy.
- Radiographic evidence of significant disc degeneration at one or two adjacent cervical levels (C4-7)
Exclusion
- Significant degeneration at more than two cervical levels,
- Prior surgical treatment of the cervical spine; laminotomy or foraminotomy allowed,
- Gross instability due to trauma,
- Disability in the lumbar spine,
- Infection in the disc or spine, past or present,
- Any active infection at time of surgery,
- Tumor in the spine,
- Significant osteoporosis or metabolic bone disease,
- Pregnant, lactating or wishes to become pregnant within duration of the study,
- Refusal to accept the use of autograft tissue.
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00215293
Start Date
August 1 2000
End Date
October 1 2007
Last Update
May 23 2014
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