Comparative analysis of Bone Marrow Aspirate versus Bone Marrow Aspirate Concentrate in Primary Knee Osteoarthritis - An Unicentric, double blinded, randomized controlled trial

This study protocol outlines a double-blinded, unicentric randomized controlled trial comparing Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC) in treating primary knee osteoarthritis. Conducted at Sri Lalithambigai Medical College and Hospital, it aims to evaluate pain relief (VAS), functional outcomes (WOMAC, KOOS), and cartilage healing (MOCART via MRI) over a 2-year follow-up. Two hundred patients aged 40–60 with Grade II–III OA will be randomized into four groups receiving either subchondral or intraarticular BMA/BMAC injections. The study fills a gap in literature, as BMA has not been previously studied for knee OA. Data will be collected using validated scoring tools and analyzed using SPSS/R. Ethical safeguards include anonymized data, informed consent, and minimal risk. The study is expected to provide insights into the comparative efficacy of BMA and BMAC, potentially influencing clinical practice and future research. A detailed timeline spans literature review, data collection, model development, and dissemination over 30 months. Supporting documents include participant information sheets, consent forms, and investigator declarations. The protocol adheres to ICMR and GCP guidelines, with institutional approvals in place. Ultimately, the research aims to expand therapeutic options for OA knee and contribute to evidence-based regenerative orthopaedic care.