P159 - Clinical outcome of a single injection with micro-fragmented autologous adipose tissue for knee osteoarthritis: 12 month follow-up study.
This study aims to evaluate the clinical progression and response rate of patients with knee osteoarthritis after a single injection with autologous micro-fragmented adipose tissue. Second, this trial wants to establish proper patient criteria to improve treatment selection in future clinical studies/practice.
Methods and Materials
Fifty-eight patients with knee osteoarthritis grade 1-4 were enrolled in this study. After lipo-aspiration, adipose tissue was processed in the Lipogem® device which eventually produced 8-10 ml of micro-fragmented adipose tissue. Patients were clinically assessed by the KOOS pain and NRS at baseline and 1, 3, 6 and 12 months after injection. Treatment responders were defined as ≥ 10 points improvement on KOOS pain relative to baseline. All patients received a pre-injection MRI which was scored according to the MOAKS criteria.
Therapy prognosticators were patients age (p<0.001), patellar synovitis (p=0.013) and bone marrow lesions (BML) (p=0.047). While the overall response rate at 12 months was 49%, response rates in patients with limited synovitis was 64% and with limited BML 75%. Clinical assessment for the overall responding group revealed an improvement in KOOS pain with 23.5 points (p<0.001), with 16.5 points (p=0.003) in case of limited synovitis and with 17.4 points (p=0.03) in patients with limited BML at 12 months. Overall NRS declined from 5.3 ± 2.2 to 2.7 ± 1.7 for responders at final follow-up (p<0.001).
This study confirms an overall response rate of 49% at 12 months with an expected clinical benefit of 23.5 points on KOOS pain and 2.6 points on VAS pain after single injection with micro-fragmented adipose tissue. A subgroup analysis of patients with limited patellar synovitis and limited bone marrow lesions revealed a response rate of 64%, clinical benefit of 16.5 points KOOS pain and 2.2 points NRS and 75% with 17.4 points KOOS and 2.6 points NRS, respectively.