2025 ISAKOS Biennial Congress Paper
Treatment of Knee Osteoarthritis With a Single Injection of Autologous Micro-Fragmented Adipose Tissue Is No Better Than Placebo. A Blinded Randomized Controlled Trial With 2-Year Follow-Up
Kristoffer W. Barfod, MD, PhD, Prof., Virum DENMARK
Lars Blønd, MD, Copenhagen DENMARK
Rasmus Kramer Mikkelsen, MD, København S, Copenhagen DENMARK
Jasmin Bagge, DVM, PhD, PhD, Hvidovre DENMARK
Thomas Kallemose, MSc, Copenhagen DENMARK
Anders Troelsen, MD, PhD, DMSc, Prof., Copenhagen DENMARK
Per Hölmich, DMSc, Prof., Copenhagen DENMARK
Copehagen University Hospital Hvidovre, Copenhagen, DENMARK
FDA Status Not Applicable
Summary
Our study suggests that point-of-care treatment of knee osteoarthritis with micro-fragmented adipose tissue is no better than placebo.
Abstract
Objective
To investigate if in patients suffering from pain and functional impairment due to knee osteoarthritis treatment with a single injection of autologous micro-fragmented adipose tissue improved the patient-reported health compared to a placebo saline injection.
Methods
A blinded randomized controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18 to 70 years with Kellgren-Lawrence grades 2–3 in the tibiofemoral joint and suffering from pain and functional impairment of the knee were eligible for inclusion. Abdominal adipose tissue was harvested by liposuction in all patients. The active treatment group was treated with an intraarticular injection of autologous micro-fragmented adipose tissue. The placebo group received an intraarticular injection of isotonic saline. The primary outcome was the Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes were amongst others KOOS at 3, 12, and 24 months, the Tegner activity score, and treatment failure.
Results
238 patients were assessed for eligibility and 120 included from January 2019 to February 2022. There were no statistically significant differences between the active treatment and the placebo group at any time point. Both groups showed statistically significant and clinically relevant improvements in all outcomes from baseline to 6, 12, and 24 months. Mean KOOS4 at 6 months was 55.5 (95% CI 51.4 to 59.6) for the active treatment group and 51.5 (95% CI 47.4 to 55.6) for the placebo group.
Conclusion
This study shows no superiority of micro-fragmented adipose tissue compared to a placebo saline injection for the treatment of knee osteoarthritis.
Trial registration: Clinical trials NCT03771989.