MRI Evaluation of Graft Maturation Following ACL Reconstruction

NCT ID: NCT07046000

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-07-31

Brief Summary

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

Conditions

ACL Tears

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ACL Reconstruction with Allograft

Subjects who have undergone ACL reconstruction with allograft

MRI

Intervention Type: DIAGNOSTIC_TEST

MRI to assess graft maturation

Interventions

MRI

MRI to assess graft maturation

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Skye Biologics Holdings, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Houston Methodist Sugar Land

Sugar Land, Texas, United States

Countries

United States

Central Contacts

Kyle Borque, MD

Role: CONTACT

kaborque@houstonmethodist.org

281-690-4678

Facility Contacts

Kyle Borque, MD

Role: primary

kaborque@houstonmethodist.org

281-690-4678

Other Identifiers

SKY-MRI-ACL-01

Identifier Type: -

Identifier Source: org_study_id