Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

NCT06311513 | Recruiting Phase 4 DMC FDA Device

• 2 other identifiers: 2023-10171177535
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

Regenerative Medicine; Orthobiologics; Concentrated Bone Marrow Aspirate; Revision ACLR

Outcome Measures

Primary Outcomes (1)

• Change from baseline in patient reported knee pain

  The primary outcome measured for this study will be postoperative knee pain. This will be achieved using the Knee Injury and Osteoarthritis Outcome Score (KOOS) standardized questionnaire, which will be electronically delivered to participants at baseline and at 6-weeks, 6-months, 12-months and 24-months postoperatively. This questionnaire measures 42 items in a Likert scale for 5 different dimensions: pain, other symptoms, activities of daily living, function in sports and recreation and knee-related quality of life. The questionnaire is scored as a percentage from 0 to 100, with 0 representing extreme knee problems and 100 indicating no knee related symptoms, and therefore better outcomes.

  Baseline, 6 weeks, 6 months, 12 months and 24 months post-operative

Secondary Outcomes (4)

• Expression of local inflammatory biomarkers

  Baseline and 6 weeks post-operative

• Concentration of circulating inflammatory biomarkers

  Baseline, 6 weeks and 12 months post-operative

• Change from baseline in cartilage morphology

  Baseline, 12 months post-operative

• Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization

  Baseline, 12 months postoperative

Study Arms (2)

Investigational Arm

EXPERIMENTAL

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).

Biological: Concentrated Bone Marrow Aspirate Injection; Procedure: Revision Anterior Cruciate Ligament Reconstruction

Control Arm

SHAM COMPARATOR

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.

Procedure: Sham Incision; Procedure: Revision Anterior Cruciate Ligament Reconstruction

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.

Also known as: cBMA, BMAC, Bone Marrow Aspirate Concentrate

Investigational Arm

Sham Incision PROCEDURE

A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.

Control Arm

Revision Anterior Cruciate Ligament Reconstruction PROCEDURE

This is the standard-of-care surgical procedure.

Also known as: Revision ACLR

Control Arm; Investigational Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Emory University: collaborator
• Arthritis Foundation: collaborator

Study Sites (2)

Emory Orthopaedics & Spine Center

Atlanta, Georgia, 30097, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Miguel Otero, Ph.D.

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel de la Huerta, MD

CONTACT

917-260-3159; delahuertamezad@hss.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-blinded randomized controlled trial. Participants will be allocated to either: 1. Investigational arm (Revision ACLR + cBMA) 2. Control arm (Revision ACLR + Sham Incision)

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: January 22, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)