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| ID | Type | Description | Link |
|---|---|---|---|
| 1177535 | Other Grant/Funding Number | Arthritis Foundation |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| Arthritis Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Arm | Experimental | Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA). |
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| Control Arm | Sham Comparator | Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of local inflammatory biomarkers | Synovial fluid collected before and 6 weeks after surgery will be analyzed using ELISA panels, looking for expression and concentration of markers of inflammation (e.g. IL-1β, TNFα) and matrix remodeling (COMP, CTXII) | Baseline and 6 weeks post-operative |
| Concentration of circulating inflammatory biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel de la Huerta, MD | Contact | 917-260-3159 | delahuertamezad@hss.edu |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Otero, Ph.D. | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Orthopaedics & Spine Center | Recruiting | Atlanta | Georgia | 30097 | United States | |
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This is a single-blinded randomized controlled trial. Participants will be allocated to either:
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| Sham Incision | Procedure | A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested. |
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| Revision Anterior Cruciate Ligament Reconstruction | Procedure | This is the standard-of-care surgical procedure. |
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Biological samples (urine and blood) will be collected intraoperatively, and at 6-weeks and 12-months post-operatively. Samples will be processed and analyzed using ELISA panels, looking for the circulating concentration of markers of inflammation (e.g. IL-1β, TNFα) and matrix remodeling (COMP, CTXII). |
| Baseline, 6 weeks and 12 months post-operative |
| Change from baseline in cartilage morphology | Proton density weighted fast-spin-echo images will be acquired to assess cartilage morphology preoperatively and at 12 months post-operatively. Findings will be scored using the MRI Osteoarthritis Knee Score (MOAKS), which establishes criteria for assessing lesion grade (from 0 - best to 3 - worst) in fourteen distinct subregions. | Baseline, 12 months post-operative |
| Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization | Combined T1ρ-T2 quantitative MRI image acquisition protocol will help determine the changes in relative proteoglycan content and collagen fibril organization within the knee articular cartilage. | Baseline, 12 months postoperative |
| Hospital for Special Surgery |
| Recruiting |
| New York |
| New York |
| 10021 |
| United States |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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