Observational Study on Return to Play After ACL Reconstruction

This study is looking at how quickly people can return to sports after a specific type of ACL (Anterior Cruciate Ligament) reconstruction surgery. This surgery, called "Fertilized ACL," uses bone marrow aspirate, demineralized bone matrix (DBM), and an internal brace to help repair the ligament. Researchers want to understand how well this procedure works by tracking your ability to return to play and by performing biomechanics testing (measuring how your body moves). They are also interested in a specific biological process called RAF. The study is open to individuals aged 14 to 26 who need ACL reconstruction and are skeletally mature. The goal is to see what success looks like for patients returning to their activities.

Study design
This is an observational study planning to enroll 450 participants. It is not a randomized trial, meaning you would not be assigned to different treatment groups.
What's involved
You would provide baseline information through surveys and physical exams before surgery. After surgery, you would have return-to-sport evaluations at 3, 4, 5, 6, 9, and 12 months, and an MRI at 6 months.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for return to play from 6 months after surgery until the study concludes, and for biomechanics testing at 4.5 and 6 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06294314

Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace

Recruiting
Not specifiedAges 14–26Observational
Marshall University
~450 participants
Updated 2024-03-05 on ClinicalTrials.gov
What's tested:Fertilized ACL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Return to play
Measured over 6 months after surgery until study conclusion
+1 more outcome measured
Anterior Cruciate Ligament Rupture

NCT06294314

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Marshall University

    Huntington, West Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

Exclusion

An understanding of the purpose of the study and providing written informed consent.
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.
  • Return to play6 months after surgery until study conclusion

    Patient will be monitored for return to play at their sport

  • Biomechanics testing4.5 months after surgery and 6 months after surgery

    Patient will undergo hop testing for limb symmetry