Treatment of knee osteoarthritis with a single injection of autologous micro-fragmented adipose tissue is not superior to a placebo saline injection: a blinded randomised controlled trial with 2-year follow-up

Objective To investigate if treatment with a single injection of autologous micro-fragmented adipose tissue improved patient-reported health compared with a placebo saline injection in patients suffering from pain and functional impairment due to knee osteoarthritis. Methods We conducted a randomised controlled trial with patients blinded to the treatment and allocated in a 1:1 ratio to one of two parallel groups. Patients aged 18–70 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 intra-articular injection of autologous micro-fragmented adipose tissue, and the placebo group with isotonic saline. The primary outcome was the Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Results 238 patients were assessed for eligibility and 120 (mean age 52.2, 58% female) 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 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 did not show superiority of micro-fragmented adipose tissue compared with a placebo saline injection for the treatment of knee osteoarthritis. Trial registration number [NCT03771989][1]. Data are available upon reasonable request. Individual deidentified participant data that underlie the results reported in this paper (text, tables, figures and appendices) and the study protocol will be shared if requested and approved by the Danish Data Regulation Authority. Data will be available beginning 1 month and ending 5 years after publication of this paper. Data will be available for researchers who provide a methodologically sound scientific proposal, which has been approved by an ethical committee. Proof of the latter should be provided. Analyses should achieve the aims reported in the approved proposal. Proposals for data should be directed to the corresponding author (Kristoffer.barfod@regionh.dk). [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03771989&atom=%2Fbjsports%2Fearly%2F2025%2F03%2F18%2Fbjsports-2024-108732.atom