Status:
ACTIVE_NOT_RECRUITING
Bio ACL Reconstruction Amnion Collagen Matrix Wrap and Stem Cells
Lead Sponsor:
Andrews Research & Education Foundation
Collaborating Sponsors:
Arthrex, Inc.
Conditions:
ACL - Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Collagen based -membrane derived from amniotic tissue can be used to help reestablish the natural synovial lining of the reconstructed ACL, in effect acting as both a barrier from the synovial fluid a...
Detailed Description
Histologic studies have determined that graft ligamentization following anterior cruciate ligament (ACL) reconstruction may take from 6 to 18 months. (1) It has been reported that incomplete graft mat...
Eligibility Criteria
Inclusion
- Patients between the ages of 18 and 45 who are scheduled to have anterior cruciate ligament reconstruction with autologous grafts by one of the investigating physicians will be screened for participation in this study.
- Patients must be willing to undergo MRI scans post -operatively at 3, 6, 9 months and 1 year
Exclusion
- Patients with prior procedures or significant prior injuries to the same knee are excluded. - - Any patient who will have difficulty obtaining internet access, does not have an active e-mail address, or is unable to comprehend study documents or give informed consent will be excluded.
- Patient who are unable to complete MRI examinations due to claustrophobia or anxiety will be excluded.
Key Trial Info
Start Date :
September 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03294759
Start Date
September 6 2017
End Date
December 6 2024
Last Update
February 21 2024
Active Locations (1)
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1
Andrews Institute
Gulf Breeze, Florida, United States, 32561