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

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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.

OriginalsprogEngelsk
Artikelnummer748
TidsskriftTrials
Vol/bind22
Udgave nummer1
ISSN1745-6215
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
The study is facilitated by the department of Orthopaedic Surgery at Copenhagen University Hospital Hvidovre and Zealand University Hospital. The authors would like to thank the respective heads of the departments Thue ?rsn?s and Thomas Michael Nissen-Juul S?rensen. The authors would like to thank Lipogems? company for delivering equipment and helping in training before the study started. The authors thank all participants for their involvement in the study. KWB and LB had the idea for the study and prepared the protocol. They are responsible for study design, analysis of data, writing of the report and publication. RKM, KWB and LB are responsible for establishing the database, recruitment of patients, data collection and storage of data according to the guidelines of the Danish Data Protection Agency. RKM, KWB and LB are performing the surgeries. CM is responsible for recruitment of patients, data collection and storage of data. AT, PH and LRH have taken part in designing the study. LRH has been responsible for teaching the liposuction technique to RKM, KWB and LB prior to study start and supervision of the liposuctions performed in the study. All authors read and approved the final manuscript. The study?s main sponsors are the Department of Orthopaedic Surgery at Copenhagen University Hospital Hvidovre and Zealand University Hospital. Lipogems? are delivering the equipment free of charge for the study. The authors have independently initiated the study. Funders have no and will not have any role in regard to the study design; data collection; management, analysis and interpretation of data; writing the report; and the decision to submit the report for publication. Patients do not receive any fees for participation. KWB, RM and LB have access to the full dataset. Access to a de-identified dataset is given to the study nurse at the two centres.

Publisher Copyright:
© 2021, The Author(s).

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