Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Multi-Center Pilot Study to Evaluate Concentrated Bone Marrow Aspirate (cBMA) as a Treatment to Modify Post-Traumatic Osteoarthritis (PTOA) Following Revision Anterior Cruciate Ligament Reconstruction (ACLR)

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Condition
Anterior Cruciate Ligament Injuries
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory Orthopaedics & Spine Center, Atlanta, Georgia, United States, 30097

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hospital for Special Surgery, New York,

Miguel Otero, Ph.D., PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

Study Record Dates

2028-12