Not yet recruiting NCT07046000
MRI Evaluation of Graft Maturation Following ACL Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: ACL Tears. Basic parameters: 14 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Magnetic Resonance Imaging (MRI) Evaluation of Graft Maturation Following Anterior Cruciate Ligament (ACL) Reconstruction With a Connective Tissue Allograft
Overview
Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.
Interventions
- Diagnostic test MRI
MRI to assess graft maturation
Primary outcome measures
- Graft Maturation via MRI [Time frame: From 4.5 months post surgery until 12 months or graft maturation.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Houston Methodist Sugar Land — Sugar Land
Identifiers
NCT: NCT07046000 · SKY-MRI-ACL-01