MRI Evaluation of Graft Maturation Following ACL Reconstruction

NCT07046000 | Not Yet Recruiting

• 1 other identifier: SKY-MRI-ACL-01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  From 4.5 months post surgery until 12 months or graft maturation.

Study Arms (1)

ACL Reconstruction with Allograft

Subjects who have undergone ACL reconstruction with allograft

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

MRI to assess graft maturation

ACL Reconstruction with Allograft

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subject who received primary ACL surgery at Houston Methodist Sugar Land.

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.

Sponsors & Collaborators

• Skye Biologics Holdings, LLC: lead

Study Sites (1)

Houston Methodist Sugar Land

Sugar Land, Texas, 77479, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Kyle Borque, MD

CONTACT

281-690-4678; kaborque@houstonmethodist.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 1, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)