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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Page 1 of 1 (2 locations)

1

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy, 20161

2

Istituto Ortopedico Galeazzi

Milan, Italy, 20161