Use of Lipogems for Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

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.
    

Intervention name(s): autologous microfragmented lipoaspirate tissue (Lipogems®).; arthroscopic debridment
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; patient in supine position. Under sedation is perform an arthroscopic debridement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment