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Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

RecruitingPhase 4Ages 18 Years - 55 YearsAllHospital for Special Surgery, New York
NCT06311513 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Males and Females * Age 18 to 55 * Previous unilateral ACLR (Anterior Cruciate Ligament Reconstruction) within the last 5 years, and identified as having experienced failure of the primary ACLR * Scheduled to have a revision ACLR surgery, with any graft type (including patellar tendon, hamstring, quad or allograft) * Able to complete all study procedures and participate in a standardized physical therapy program Exclusion Criteria: * History of inflammatory arthritis or joint sepsis * Prior or concurrent total or sub-total meniscectomy * Prior or present avascular necrosis of the index knee * Oral or intra-articular corticosteroid injection within 3 months * Hyaluronic acid or PRP (Platelet-Rich Plasma) injection within 6 months * Use of duloxetine, doxycycline, indomethacin, glucosamine and/or chondroitin (ongoing or within 2 months) * Any clinical or laboratory abnormality greater than grade 3 CTCAE, which in the view of the investigator, will compromise the participant's safety. * Planned arthroplasty in the index knee
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What it tests

  • Concentrated Bone Marrow Aspirate Injection
  • Sham Incision
  • Revision Anterior Cruciate Ligament Reconstruction
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Where

2 sites
Emory Orthopaedics & Spine Center
Atlanta, United States
Hospital for Special Surgery
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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