Comparing two types of grafts for ACL reconstruction
All Soft Tissue Quadriceps Tendon Autograft Versus Patellar Tendon Autograft in Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
This study is testing which type of graft, quadriceps tendon or bone-patellar tendon-bone, helps people recover better after ACL surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05461326 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of quadriceps tendon autografts versus bone-patellar tendon-bone autografts in patients undergoing ACL reconstruction. Patients will be recruited from the Highlands Sports Medicine Clinic and will be randomized into two groups to receive either graft type. The study will assess outcomes related to recovery and performance post-surgery, with a total of 100 participants expected. The trial will ensure blinding of the research personnel and participants to maintain objectivity in the results.
Who should consider this trial
Good fit: Ideal candidates for this study are skeletally mature patients under 65 years old who require ACL reconstruction and are suitable for autograft harvest.
Not a fit: Patients who are over 65, have poor tissue quality, or are not compliant with post-operative rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the optimal graft choice for ACL reconstruction, potentially improving recovery outcomes for patients.
How similar studies have performed: While there has been limited research comparing these specific graft types, previous studies have shown varying success with different autograft options in ACL reconstruction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Skeletally mature patients younger 65 * ACL insufficiency * Scheduled to undergo autograft ACL reconstruction * Appropriate candidate for autograft harvest Exclusion Criteria: * \<14 or 65\> * Poor autograft candidate (poor tissue quality) * Multi ligamentous reconstruction (PCL, MCL, or PLC) * Pregnant or nursing * High likelihood of remaining non-compliant with physical therapy regimen * Desire to return to sport prior to 6 months * Inability to read and write English
Where this trial is running
Birmingham, Alabama
- UAB Hospital Highlands — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Amit Momaya, MD — Department of Orthopaedic Surgery, University of Alabama at Birmingham
- Study coordinator: Amit Momaya, MD
- Email: amomaya@uabmc.edu
- Phone: 864-436-0621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.