MRI Evaluation of Graft Maturation Following ACL Reconstruction

Starting soon

Conditions studied: ACL Tears

In brief

Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.

Key facts

Study ID

NCT07046000

Run by

Skye Biologics Holdings, LLC

People needed

10

Starts

2026-08-01

Expected to finish

2028-02-01

Last updated by the study team

2026-04-24

Who can join

Age: 14 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Houston Methodist Sugar Land — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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