MRI Evaluation of ACL Graft Maturation

This observational study is looking at how the new tissue (graft) used in ACL (anterior cruciate ligament) reconstruction surgery matures over time. Researchers will use MRI (magnetic resonance imaging) scans to assess graft maturation. You may be able to join if you are between 14 and 50 years old, have had a first-time ACL tear and reconstruction in the past 12 months, and have no other knee ligament injuries. The main goal is to understand graft maturation through MRI from 4.5 to 12 months after surgery. The current recruitment status is unclear, and the study plans to enroll 10 participants.

Study design
This is an observational study, meaning participants will be monitored without receiving a specific intervention from the study. It plans to enroll 10 participants.
What's involved
You would have MRI scans at 4.5, 6, 7.5, 9, 10.5, and 12 months after your ACL surgery.
Compensation
Not stated in the trial record.
Follow-up
Your graft maturation will be assessed from 4.5 months post-surgery until 12 months or until graft maturation is observed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07046000

MRI Evaluation of Graft Maturation Following ACL Reconstruction

Not Yet Recruiting
Not specifiedAges 14–50Observational
Skye Biologics Holdings, LLC
~10 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:MRI

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Graft Maturation via MRI
Measured over From 4.5 months post surgery until 12 months or graft maturation.
ACL Tears

NCT07046000

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Houston Methodist Sugar Land

    Sugar Land, Texasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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
Have current imaging studies (plain radiographs and MRI exams within the past 12 months) of the knee to rule out other etiologic diagnoses
Patient underwent ACL reconstruction with a Bone-Patellar Tendon-Bone (BTB) graft harvested from the same knee (ipsilateral autograft) with the Active Matrix tissue
Able and willing to comply with the post-operative study follow-up schedule

Exclusion

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
Patient underwent ACL reconstruction with a hamstring tendon, Achilles tendon or quadriceps tendon graft (any graft other than a patellar tendon BTB)
Contraindication to MRI (eg, implanted devices incompatible with MRI).
Chrondral lesion of the knee that requires treatment during ACL reconstruction surgery
History of advanced osteoarthritis of the knee or patella-femoral joint; KL grade III or higher
History of malignant tumor and osseous metastatic disease,
History of chronic pain disorders (i.e., fibromyalgia),
Current substance abuse (drug or alcohol), by the investigator's judgment,
Females who are pregnant, nursing or breastfeeding, or who intend to become pregnant during participation in the study.
Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
Currently involved in any injury litigation or workers compensation claims,
Has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.
  • Graft Maturation via MRIFrom 4.5 months post surgery until 12 months or graft maturation.

    The signal to noise ratio will be calculated at the proximal, mid-substance, and distal positions of the graft