MRI Evaluation of Graft Maturation Following ACL Reconstruction

Launched by SKYE BIOLOGICS HOLDINGS, LLC · Jun 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well a repaired ACL (an important ligament in the knee) heals over time after surgery. Researchers will use MRI scans—special imaging tests—to look at the new ligament (called a graft) at several points after surgery, from about 4.5 months up to 12 months. This helps doctors understand how the graft matures and strengthens during recovery.

To join the study, participants must have had a first-time ACL tear in one knee that was repaired using a specific type of graft taken from their own knee (called a bone-patellar tendon-bone graft). The injury should have happened less than a year before surgery, and the person needs to have recent knee images to make sure no other problems are present. People with other knee ligament injuries, previous knee surgeries, or certain health conditions won’t be eligible. If accepted, participants will have several MRI scans scheduled after their surgery to track healing. This study is not yet recruiting, but it aims to help improve understanding of ACL recovery to better guide future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.