A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol.

Early human evidence such as case series or small samples is exploring possible benefits.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background Osteoarthritis (OA) is a highly debilitating joint disease that causes progressive, irreversible damage to articular cartilage. OA takes a massive toll on society that has grown in recent decades, but no therapy has been shown to halt or reverse the progression of the disease. The critical need for better treatments and increased interest cellular therapies has spawned a new generation of "minimally manipulated" cell treatments. Autologous adipose tissue injections are among the most controversial of these new treatments. Despite a lack of clinical evidence, adipose tissue injections are often marketed as "stem cell" injections with wide-ranging regenerative benefits. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA. Methods This is a prospective, single-center, parallel-group, randomized, controlled trial. Participants (n = 54) will receive either a single intra-articular, ultrasound-guided injection of autologous adipose tissue or a single intra-articular, ultrasound-guided injection of HA (1:1 ratio). Outcome data will be obtained at baseline, week-6 and month-6. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain domain (WOMAC-A) will be used as the

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

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