Status:
COMPLETED
Use of Lipogems for Knee Osteoarthritis
Lead Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
45-75 years
Phase:
NA
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 p...
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 evaluatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04427657
Start Date
November 8 2018
End Date
December 1 2020
Last Update
July 6 2021
Active Locations (2)
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1
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy, 20161
2
Istituto Ortopedico Galeazzi
Milan, Italy, 20161