Treatment of Osteoarthritis With Autologous, Microfragmented Adipose Tissue.

Summary

The study is a blinded, multicenter, randomized, controlled trial with participants individually randomized to one of two parallel groups: 1. The intervention group: Participants receive one intra articular injection with autologous, microfragmented adipose tissue. 2. The control group: Participants receive one intra articular injection with Saline (placebo). The objective of the study is to investigate if intra-articular injection with autologous, microfragmented adipose tissue prepared using the Lipogems system affects the patient reported outcome in patients with osteoarthritis of the knee. The primary endpoint is KOOS4 evaluated at 6 months after the intervention. Secondary endpoints are the KOOS including all five subscales evaluated after 6months, 1 and 2 years.

Timeline

Start

2019-01-01

Primary completion

2022-02-28

Completion

2024-03-30

Publications

• Barfod KW, Blond L, Mikkelsen RK, Bagge J, Holmich LR, Kallemose T, Troelsen A, Holmich P. 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. Br J Sports Med. 2025 Aug 26;59(17):1219-1227. doi: 10.1136/bjsports-2024-108732.

Drugs

Indications