MRI Evaluation of Graft Maturation Following ACL Reconstruction
ConditionACL Tears
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-50
SponsorSkye Biologics Holdings, LLC
About this trial
Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ACL tear and reconstruction; no other knee ligaments needing reconstruction
Primary (first-time) ACL tear in the affected knee
ACL injury occurred less than 12 months before ACL reconstruction
Have no contraindications or allergies to the treatment administered
Disqualifiers
Prior surgery on the index knee within 12 months of enrollment
Steroid injection into the index knee within 6 weeks of enrollment
Chronic ACL tear whereas the injury occurred more than 12 months ago
Multiligamentous injuries whereas any ligament (MCL, PCL, or PLC) in addition to the ACL needs to be reconstructed
Trial population
Subject who received primary ACL surgery at Houston Methodist Sugar Land.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI
Diagnostic testMRI to assess graft maturation
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: ACL Reconstruction with Allograft1 intervention
Trial outcomes
Primary outcomes
1
Graft Maturation via MRI
The signal to noise ratio will be calculated at the proximal, mid-substance, and distal positions of the graft
Time frame
From 4.5 months post surgery until 12 months or graft maturation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: