NCT04427657

Use of Lipogems for Knee Osteoarthritis

Adipose Microfragmented Autologous Tissue for the Treatment of Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Lipogems system consist in the use of a monouse kit for liposuction, processing and administration of adipose tissue. The use of the final product (microfragmented adipose tissue,not expanded) shoud promote the natural joint homeostasis, associated with a clinical improvement

Detailed description

The Objectiveof the study is to analyse the therapeutic role of microfragmented autologous tissue for the treatment of the knee osteoarthritis (OA). Main purpose: Symptomatic and functional evaluation at 6 months by comparison of the Knee Injury and Osteoarthritis Outcome Score(KOOS) recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®). Secondary Purposes: Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImage analysis. Symptomatic and functional evaluation at 6±1 months by means of VisualAnalogueScale, KneeSocietyScore, Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Reduction of anti-inflammatory drugs (pre-intervention versus 6±1 months). Evaluation "quality-adjusted life years" (QUALY) in relation to the questionnaire SatisfactioForm-12 (pre-intervention vs 6±1 months). Check for any adverse effects directly related to the use of micro-fragmented adipose tissue. Changes in serum levels of biomarkers related to OA (CollagenType II C-Telopeptide (CTX-II), collagen type III N-propeptide (PIIINP)) will be evaluated (pre-intervention vs 6±1 months). The study is an interventional, prospective, randomized, controlled trial. Controls: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement. Cases: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®). Surgical technique: patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	autologous microfragmented lipoaspirate tissue (Lipogems®).	patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.
PROCEDURE	arthroscopic debridment	patient in supine position. Under sedation is perform an arthroscopic debridement

Timeline

• Start date: 2018-11-08
• Primary completion: 2019-12-31
• Completion: 2020-12-01
• First posted: 2020-06-11
• Last updated: 2021-07-06

Locations

2 sites across 1 country: Italy