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

Abstract

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.

Keywords: Biologic treatment; Knee osteoarthritis; MSCs; Micro-fragmented adipose tissue; Pericyte; Randomized controlled trial; Stemcell.

Conflict of interest statement

Lipogems® has contributed significantly to the study. The equipment from Lipogems® is delivered free of charge by the company. The company also contributed to the training of the surgeons prior to the start. Lipogems® was not contacted until after the study had been designed and the first approval was granted by the National Ethics Committee. The company has had no influence on the study design or writing of the protocol. The research team has the rights to all data, analysis of the data and final publication. Lipogems® have no rights and/ or decisions in regard to the publication of the results.

None of the investigators have financial or other interests in relation to the study.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Patient flow diagram. Patients assessed for eligibility are registered according to the consort requirements and will be presented in the final study paper in a consort flow diagram like this
Fig. 2
Fig. 2
Participant time line showing the patient contacts in the study: randomization, intervention and follow-up
Fig. 3
Fig. 3
The study timeline. Inclusion of patients began in December 2018 and is expected to end November 2021

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Source: PubMed

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