Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT06311513
Phase
PHASE4
Status
Recruiting
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Conditions

  • ACL Injury
  • Anterior Cruciate Ligament Injuries
  • Bone Marrow Aspirate Concentrate
  • Post-Traumatic Osteoarthritis of Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Concentrated Bone Marrow Aspirate Injection — BIOLOGICAL
    Intraoperatively, bone marrow will be harvested from the iliac crest with a commercial kit, it will then be prepared via centrifugation and an injection of the resulting concentrated product (cBMA) will be administered in the operative knee. cBMA is an autologous biologic product.
  • Sham Incision — PROCEDURE
    A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.
  • Revision Anterior Cruciate Ligament Reconstruction — PROCEDURE
    This is the standard-of-care surgical procedure.

Study Details

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.

Key Dates

Start date
Jan 22, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Investigational Arm
    Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).
  • Sham Comparator: Control Arm
    Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.

Primary Outcome Measure

Change from baseline in patient reported knee pain [ Time Frame: Baseline, 6 weeks, 6 months, 12 months and 24 months post-operative ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory Orthopaedics & Spine CenterAtlantaGeorgia30097-
Hospital for Special SurgeryNew YorkNew York10021
Daniel de la Huerta, MD
[email protected]
212-606-1000
Miguel Otero, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Emory Orthopaedics & Spine Center· Atlanta, GAHospital for Special Surgery· New York, NY

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