Status:
COMPLETED
BioACL Reconstruction With Amnion Collagen Matrix Wrap and Stem Cells Case Series
Lead Sponsor:
Andrews Research & Education Foundation
Collaborating Sponsors:
Arthrex, Inc.
Conditions:
ACL - Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief Summary
The objective of this study is to evaluate the use of wrapping an ACL graft with a collagen matrix tissue wrap and injecting autologous bone marrow aspirate concentrate under the wrapping and into the...
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 35 who are scheduled to have anterior cruciate ligament reconstruction with autologous grafts by the principal investigator 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 :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03294720
Start Date
January 8 2018
End Date
December 31 2022
Last Update
February 1 2023
Active Locations (1)
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1
Andrews Institute
Gulf Breeze, Florida, United States, 32561