Knee Osteoarthritis
Conditions
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.
Interventions
PROCEDUREautologous 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.
PROCEDUREarthroscopic debridment
patient in supine position. Under sedation is perform an arthroscopic debridement
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Italy
Outcome results
None listed