Clinical trial NCT04427657: Use of Lipogems for Knee Osteoarthritis
Official title: Adipose Microfragmented Autologous Tissue for the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 78
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups
timeFrame: 6 month
Secondary outcomes:
measure: Radiological changes at 6 month recorded between the two groups
timeFrame: 6 month
measure: Functional changes at 6 month recorded between the two groups
timeFrame: 6 month
measure: Serum changes at 6 month recorded between the two groups
timeFrame: 6 month
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Ortopedico Galeazzi
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico GaleazziMilano
name: michele ulivi
role: PRINCIPAL_INVESTIGATOR
References: