MRI Evaluation of Graft Maturation Following ACL Reconstruction

Skye Biologics Holdings, LLC

Status

Not yet enrolling

Conditions

ACL Tears

Treatments

Diagnostic Test: MRI

Study type

Observational

Funder types

Industry

Identifiers

NCT07046000

SKY-MRI-ACL-01

Details and patient eligibility

About

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

Enrollment

10 estimated patients

Sex

All

Ages

14 to 50 years old

Volunteers

No Healthy Volunteers

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.