Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Rasmus Kramer Mikkelsen*, Lars Blønd, Lisbeth Rosenkrantz Hölmich, Cecilie Mølgaard, Anders Troelsen, Per Hölmich, Kristoffer Weisskirchner Barfod

*Corresponding author for this work


BACKGROUND: Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms.

METHODS/DESIGN: The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2-3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis.

DISCUSSION: This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient's opinion about their knee and associated problems when suffering from osteoarthritis.

Original languageEnglish
Article number748
Issue number1
Pages (from-to)1-11
Number of pages11
Publication statusPublished - 27 Oct 2021


  • Adipose Tissue
  • Humans
  • Injections, Intra-Articular
  • Knee Joint/diagnostic imaging
  • Osteoarthritis, Knee/diagnostic imaging
  • Randomized Controlled Trials as Topic
  • Treatment Outcome


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