Randomized Double-Blind Study Comparing Injections of Autologous Microfragmented Adipose Tissue with Hyaluronic Acid versus Microfragmented Adipose Tissue Alone for Symptomatic Bilateral Knee Osteoarthritis

What this Trial Is About

Researchers are evaluating treatments for adults aged 18 to 75 with symptomatic bilateral knee osteoarthritis (OA). This randomized controlled double-blind trial compares two injections: autologous microfragmented adipose tissue combined with high-molecular-weight hyaluronic acid versus autologous microfragmented adipose tissue with saline. The study aims to assess clinical outcomes and safety of these treatments in patients who have persistent knee pain despite at least six months of conservative therapies. Each participant will receive both treatments, one in each knee, with one knee injected with 6 cc of microfragmented adipose tissue plus 4 cc of hyaluronic acid, and the other knee injected with the same tissue plus 4 cc of saline. The adipose tissue is obtained from the abdominal area via liposuction and microfragmentation. Participants and researchers remain blinded to which knee receives which treatment. Follow-up visits occur at 0, 2, 6, 12, and 24 months to monitor progress. Participants will undergo assessments including questionnaires, clinical evaluations, and imaging at baseline and follow-up visits. The main outcome measured is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes include pain and function scores, patient satisfaction, range of motion, and safety monitoring. The study will document any adverse events and patient opinions on treatment effectiveness over two years.

Treatment of Symptomatic Bilateral Knee Osteoarthritis: Intra-articular Injection of Autologous Microfragmented Adipose Tissue and Hyaluronic Acid vs Intra Articular Injection of Autologous Microfragmented Adipose Tissue