Status:
WITHDRAWN
The Long-term Degradation Outcome of Bilok Screws Used for ACL Reconstruction
Lead Sponsor:
ArthroCare Corporation
Conditions:
Anterior Cruciate Ligament
Eligibility:
All Genders
18-55 years
Brief Summary
The purpose of the study is to evaluate the long term outcome of a poly L-lactic acid / β-tricalcium phosphate (BILOK) biodegradable interference fixation screw used for arthroscopic bone-patellar ten...
Detailed Description
BILOK screws have been used for ACL interference fixation in the US since the late 1990s. As yet, there are no long-term studies to demonstrate the eventual biologic outcome of these devices. Animal s...
Eligibility Criteria
Inclusion
- Prior patellar tendon autograft ACL reconstruction that used poly L-lactic acid (BILOK) interference fixation screws.
- Minimum follow-up of 3 years after the index surgery.
- Subject must be able to understand the verbiage of the consent form.
- The subject must be willing to undergo a physical examination of the previously operated knee.
- The subject must be willing to undergo a radiographic examination of the previously operated knee.
- The subject must be willing to undergo a CT scan examination of the previously operated knee.
- The subject signs the IRB-approved informed consent form.
- The subject is willing and able to complete required follow-up.
Exclusion
- Subsequent ACL surgery or bone procedures in the area of the ACL graft attachments.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00374491
Start Date
September 1 2006
Last Update
January 5 2016
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