Use of Lipogems for Knee Osteoarthritis
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Controls 39 patients with knee osteoarthritis undergoing arthroscopic debridement |
Procedure: arthroscopic debridment
patient in supine position. Under sedation is perform an arthroscopic debridement
|
| Experimental: Cases 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®). |
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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients with knee osteoarthritis grade III e IV Kellgren-Lawrence,
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age between 45 and 75,
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pain ≥ 6 VAS scale,
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no ligamentous instability,axial deviation less than 10°
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BMI between 18 and 30,
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International Normalized Ratio (INR) < 1.5
Exclusion Criteria:
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previous traumatic lesion (tibial fracture, osteothomy) of the knee
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osteonecrosis
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meniscal surgery in the previous 6 weeks
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chemiotherapy, radioteherapy
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diabetes
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alchoolism, psichiatric disease,drug addiction
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coagulation disorders
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pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Ortopedico Galeazzi | Milano | Italy | 20161 | |
| 2 | IRCCS Istituto Ortopedico Galeazzi | Milan | Italy | 20161 |
Sponsors and Collaborators
- Istituto Ortopedico Galeazzi
Investigators
- Principal Investigator: michele ulivi, IRCCS Istituto Ortopedico GaleazziMilano
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LipoOA