Kristoffer Weisskirchner Barfod (1)
Lars Blønd (2)
Rasmus Kramer Mikkelsen (1)
Libeth Rosenkrans Hölmich (3)
- Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Copenhagen, Denmark
- Department of Orthopedic Surgery, Zealand University Hospital Køge, Denmark
- Department of Plastic Surgery, Copenhagen University Hospital, Herlev-Gentofte, Copenhagen, Denmark
About the study/project
This is a multicentre, parallel-group, randomized, controlled, double blinded trial. 120 patients aged 18–70 years with osteoarthritis of the knee Kellgren-Lawrence grade 2 – 3 in the tibiofemoral joint will be randomly allocated to one of two groups (1:1 ratio). Participants randomized to active treatment will have an intra-articular injection with autologous, microfragmented adipose tissue prepared using the Lipogems system, while participants allocated to the control group will have an injection with saline.
The primary outcome will be the change from baseline to 6 months in the mean score on four Knee Injury and Osteoarthritis Outcome Score subscales, covering pain, symptoms, function in sports and recreation and quality of life (Knee Injury and Osteoarthritis Outcome Score (KOOS4)) supported by the individual subscale scores allowing clinical interpretation.
The Trial period is from the 1st of May 2018 to the 31st of October 2021.
Purpose of the study/project
The prupose of the study is to investigate if an 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.