Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace
Marshall University · with Arthrex, Inc. · NCT06294314
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 14–26 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 450
- US sites recruiting
- 1
- Study start
- February 26, 2024
- Record last updated
- March 5, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.
Being studied: Fertilized ACL
Conditions: Anterior Cruciate Ligament Rupture
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Marshall University
Huntington, WV 25755
Site contact: chad d lavender, md · 304-552-6514 · doclav@gmail.com
Study contacts (from the official record)
- chad d lavender, md · 304-552-6514 · doclav@gmail.com
- Kara Cipriani, NP · 304-541-5316 · cipriani6@marshall.edu
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