Rush University Medical Center
Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.
The purpose of this study is to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50 per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incis…
Inclusion Criteria: * Patients between the ages of 18-70 * Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks * 7-day average pain score of at least 4 on VAS scale Exclusion Criteria: * Systemic diseases (Diabetes, malignancies, infections, etc.) * Post-traumatic arthritis * Patient had intra-articular injection on affected knee in last three months
Bone marrow aspirate concentrate BMAC is a biologically substance harvested from a patient for autologous use. Bone marrow aspirate concentrate (BMAC) has been determined by the FDA to be a minimally manipulated biologic prepared for autologous use and does not require premarket FDA approval for clinical use.
Current standard of treatment for OA of the knee is corticosteroid injection.
Subjects who participate in this study and who are randomized to receive the BMAC may experience decreased pain and increased functionality after the injection compared to those that receive a corticosteroid injection. As such, participants who continue to have pain after a corticosteroid injection will be allowed to crossover to a BMAC injection at 24 weeks or 6 months post-surgery.(ARM 3)
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