Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-22

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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Anterior cruciate ligament reconstruction (ACLR) surgery is considered a relatively safe and effective procedure, however, up to 18% of grafts will fail and require revision surgery. Some studies have shown that these patients may be at increased risk of worse clinical outcomes, including fast progression toward post-traumatic osteoarthritis (PTOA). This is likely in part due to the inflammatory environment created within the joint. Concentrated bone marrow aspirate (cBMA) is a regenerative medicine therapy that contains soluble factors and connective tissue progenitor cells which may have immunomodulatory and pro-regenerative potential. The use of this therapy in conjunction with standard of care surgical treatment may help reduce the inflammatory microenvironment inside the joint, therefore modifying the conditions that might lead to developing long term complications such as PTOA.

The investigators hypothesize that cBMA treatment at the time of revision ACLR may improve clinical outcomes at 1 year after surgery and reduce the risk of developing PTOA-associated symptoms.

Participants will be randomized to either get a cBMA injection (investigational arm) at the time of surgery or a placebo incision (control arm). Biological specimens (blood, urine, synovial fluid), imaging data, functional tests and patient reported clinical outcomes will be measured at different time points during the study, for up to two years after the surgery. This will allow the investigators to evaluate the effect of cBMA in clinical outcomes. Biological specimens will be analyzed using molecular biology techniques to determine their composition, including the concentration of cells and other inflammatory markers.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Investigational Arm

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

Group Type EXPERIMENTAL

Concentrated Bone Marrow Aspirate Injection

Intervention Type 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.

Revision Anterior Cruciate Ligament Reconstruction

Intervention Type PROCEDURE

This is the standard-of-care surgical procedure.

Control Arm

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

Group Type SHAM_COMPARATOR

Sham Incision

Intervention Type PROCEDURE

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

Revision Anterior Cruciate Ligament Reconstruction

Intervention Type PROCEDURE

This is the standard-of-care surgical procedure.

Interventions

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Concentrated Bone Marrow Aspirate Injection

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.

Intervention Type BIOLOGICAL

Sham Incision

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

Intervention Type PROCEDURE

Revision Anterior Cruciate Ligament Reconstruction

This is the standard-of-care surgical procedure.

Intervention Type PROCEDURE

Other Intervention Names

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cBMA BMAC Bone Marrow Aspirate Concentrate Revision ACLR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No