Use of Lipogems for Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adipose Microfragmented Autologous Tissue for the Treatment of Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: autologous microfragmented lipoaspirate tissue (Lipogems®).
* Procedure: arthroscopic debridment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Controls<br>39 patients with knee osteoarthritis undergoing arthroscopic debridement | Procedure: arthroscopic debridment<br>* patient in supine position. Under sedation is perform an arthroscopic debridement<br>|
| Experimental: Cases<br>39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®). | Procedure: autologous microfragmented lipoaspirate tissue (Lipogems®).<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups | 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®). | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological changes at 6 month recorded between the two groups | Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImaging analysis. | 6 month | 
| Functional changes at 6 month recorded between the two groups | Symptomatic and functional evaluation at 6±1 months by means of Proms that inclued questionnaire about quality of life (SF-12, WOMAC) | 6 month | 
| Serum changes at 6 month recorded between the two groups | 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). | 6 month |