NCT06294314 · Marshall University
Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace
What this study is about
The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.
View original scientific description
The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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:
- 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
- Huntington, West Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2024 · Source of record for eligibility and locations