The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.
Recent studies have demonstrated both the safety of BMAC intra-articular injection and improvements in subjective, patient reported outcomes in patients with existing knee OA. Unfortunately these studies were largely uncontrolled, underpowered, and/or retrospective in nature. Additionally, a recent prospective, randomized clinical study of allograft mesenchymal stem cells (MSCs) injected at a separate time point post surgical intervention has highlighted the ability of MSCs to increase meniscal volume and improve knee pain following injection. This will be the first study to examine the effects of autograft BMAC intra-articular injection in a single-stage procedure and in a prospective, randomized, double-blind fashion. The results of this study, if the null hypothesis is rejected, will have far-reaching implications for the standard of care in meniscal treatment and on OA progression in the knee. Additionally, if the results of this study are favorable in reduction of OA progression this study will change the surgical approach to all axial, synovial joints including the shoulder, elbow, wrist, hip, and ankle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.
All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.
Rush University Medical Center
Chicago, Illinois, United States
International Knee Documentation Committee (IKDC) Score
The primary outcome measure will be the IKDC score at one year follow-up
Time frame: One Year
Patient reported outcomes throughout follow-up period
Patient reported outcomes will include change in scores from preoperative to Postoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Synovial fluid analysis
To investigate any changes in synovial fluid markers of osteoarthritis.
Time frame: 2 weeks, 6 weeks
Radiographic analysis
The degree of OA will be examined in all patients preoperatively and at subsequent follow-up visits at 1 and 2 years.
Time frame: 1 year, 2 years
Patient reported outcomes throughout follow-up period (VAS)
Visual Analog Score (VAS)
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (IKDC)
International Knee Documentation Committee form (IKDC)
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (KOOS)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (SF-12)
(Short Form Health Survey) SF-12
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
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