Evaluating return to play after ACL surgery with specific treatments
Return to Play After Anterior Cruciate Ligament Reconstruction With Bone Marrow Aspirate, Demineralized Bone Matrix, and an Internal Brace
This study is testing how different treatments after ACL surgery affect young athletes' chances of getting back to their sport.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 14 Years to 26 Years |
| Sex | All |
| Sponsor | Marshall University Academic / other |
| Locations | 1 site (Huntington, West Virginia) |
| Trial ID | NCT06294314 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of ACL reconstruction on athletes' ability to return to play by collecting various outcome measures and biomechanical data. Participants aged 14-26 who are undergoing ACL surgery will provide baseline information and undergo evaluations at multiple time points post-surgery. The study will assess factors such as graft type, surgical complications, and costs associated with the procedure. Additionally, MRI scans will be conducted at six months to evaluate bone healing.
Who should consider this trial
Good fit: Ideal candidates are skeletally mature individuals aged 14-26 with an ACL deficient knee seeking reconstructive surgery.
Not a fit: Patients requiring multi-ligament surgeries or those who have previously undergone ACL reconstruction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery protocols and improve return-to-play rates for young athletes after ACL reconstruction.
How similar studies have performed: While similar studies have explored ACL reconstruction outcomes, this specific approach with bone marrow aspirate and internal brace is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * INCLUSION CRITERIA: All patients must meet the following criteria: * Patients must be age 14-26 years old. * Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation. * Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity * Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, and such pathology and treatment will be recorded. * An understanding of the purpose of the study and providing written informed consent. Exclusion Criteria: * EXCLUSION CRITERIA: * Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction), * Patients who have undergone previous ACL reconstructive surgery. * Patients who are currently pregnant or nursing. * Patients who have a current infection at the operative site. * Any condition or personal issue that the surgeon deems ineffective to the outcome of the study.
Where this trial is running
Huntington, West Virginia
- Marshall University — Huntington, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: chad d lavender, md
- Email: doclav@gmail.com
- Phone: 304-552-6514
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.