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Clinical Trials in the USA / NCT07046000
Starting soon Observational

MRI Evaluation of Graft Maturation Following ACL Reconstruction

NCT07046000 · tracked via the Priya Life Science USA tracker
Sponsor
Skye Biologics Holdings, LLC
Phase
Observational
Started
2026-08-01
Last updated
2026-04-24

Condition(s) studied

ACL Tears

Investigational drug(s) / intervention(s)

MRI

MRI: MRI to assess graft maturation

Study summary

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

Eligibility

Sex
ALL
Min age
14 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Houston Methodist Sugar Land Sugar Land Texas

More Skye Biologics Holdings, LLC trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07046000 on ClinicalTrials.gov ↗ ← All trials in the USA