Status:
UNKNOWN
Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.
Lead Sponsor:
Peking University People's Hospital
Conditions:
Cervical Disc Disease
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
The objective of this study is to investigate the clinical and radiological results of two-level cervical ProDisc-C vivo versus hybrid construct.
Detailed Description
This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing two level ProDisc-C vivo artificial cervical disc replacement and hybrid construct, i.e., combining ACDF (Anterio...
Eligibility Criteria
Inclusion
- A diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from C-3 to C-7.
- The symptom is unresponsive to nonoperative treatment for at least 6 weeks.
- The patient demonstrates progressive symptoms calling for immediate surgery.
Exclusion
- Any prior cervical spine surgery.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
542 Patients enrolled
Trial Details
Trial ID
NCT03367052
Start Date
January 1 2018
End Date
December 1 2025
Last Update
December 8 2017
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