Status:
UNKNOWN
A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo
Lead Sponsor:
Peking University People's Hospital
Conditions:
Disk Degeneration
Cervical Disc Disease
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
The object of this study is to assess the long-term safety and efficacy of cervical disc replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center trial with 7 years...
Detailed Description
This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing ProDisc-C vivo artificial cervical disc replacement and ACDF (Anterior cervical discectomy fusion) to treat degen...
Eligibility Criteria
Inclusion
- Single-level cervical disc disease.
- At least one additional confirmatory neuroradiographic study, such as MRI or CT- enhanced myelography that showed findings consistent with clinical findings and complaints.
Exclusion
- Patients have cervical spinal conditions other than single-level symptomatic degenerative disc disease or evidence of instability.
- Symptomatic disc disease at level C2 -3 or C7-T1.
- A history of discitis.
- A medical condition that required medication,such as steroids or nonsteroidal antiinflammatory medications that could interfere with fusion.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT03367039
Start Date
March 1 2018
End Date
March 1 2025
Last Update
December 8 2017
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