Comparing Bone Marrow Aspirate Concentrate and Corticosteroid Injections for Knee Osteoarthritis Randomized Trial Evaluating Pain and Function Outcomes

What this Trial Is About

Researchers are evaluating the effects of bone marrow aspirate concentrate BMAC compared to corticosteroid injections on patient-reported outcomes in adults with primary osteoarthritis of the knee. This randomized controlled trial aims to understand how these treatments influence pain and function over a six-month period, with extended follow-up for some patients. The study plans to enroll 100 patients with knee osteoarthritis who have not found relief from conventional therapies. Participants will be randomly assigned to receive either an injection of their own concentrated bone marrow cells BMAC or a corticosteroid injection. Those receiving corticosteroid injections will experience a sham incision to maintain study masking. Patients who do not improve after 24 weeks on corticosteroids may switch to the BMAC treatment with follow-up continuing up to 12 months. The BMAC is prepared using an FDA-approved device to concentrate cells from the patients bone marrow. During the study, researchers will monitor pain and knee function using several validated scales, including the Visual Analogue Scale VAS for pain, the Intermittent and Constant Osteoarthritis Pain ICOAP questionnaire, and the Knee Injury and Osteoarthritis Outcome Score KOOS. Assessments will occur from enrollment through six months, or 12 months for those who switch treatments. The study includes careful follow-up to track changes in symptoms and overall knee health throughout the participation period.

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection