Use of Lipogems for Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Procedure: autologous microfragmented lipoaspirate tissue (Lipogems®).Procedure: arthroscopic debridment
- Registration Number
- NCT04427657
- Lead Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- patients with knee osteoarthritis grade III e IV Kellgren-Lawrence,
- age between 45 and 75,
- pain ≥ 6 VAS scale,
- no ligamentous instability,axial deviation less than 10°
- BMI between 18 and 30,
- International Normalized Ratio (INR) < 1.5
- previous traumatic lesion (tibial fracture, osteothomy) of the knee
- osteonecrosis
- meniscal surgery in the previous 6 weeks
- chemiotherapy, radioteherapy
- diabetes
- alchoolism, psichiatric disease,drug addiction
- coagulation disorders
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cases autologous microfragmented lipoaspirate tissue (Lipogems®). 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®). Controls arthroscopic debridment 39 patients with knee osteoarthritis undergoing arthroscopic debridement
- Primary Outcome Measures
Name Time Method Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups 6 month Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
- Secondary Outcome Measures
Name Time Method Radiological changes at 6 month recorded between the two groups 6 month Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImaging analysis.
Functional changes at 6 month recorded between the two groups 6 month Symptomatic and functional evaluation at 6±1 months by means of Proms that inclued questionnaire about quality of life (SF-12, WOMAC)
Serum changes at 6 month recorded between the two groups 6 month Changes in serum levels of biomarkers related to Osteoarthritis (collagen type II C-telopeptide(CTx-II),collagen type III N-propeptide( PIIINP)) will be evaluated (pre-intervention vs 6±1 months).
Trial Locations
- Locations (2)
Istituto Ortopedico Galeazzi
🇮🇹Milano, Italy
IRCCS Istituto Ortopedico Galeazzi
🇮🇹Milan, Italy