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Use of Lipogems for Knee Osteoarthritis

NCT04427657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-07-06

No results posted yet for this study

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

Conditions

Interventions

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.

PROCEDURE

arthroscopic debridment

patient in supine position. Under sedation is perform an arthroscopic debridement

Sponsors & Collaborators

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    lead OTHER

Principal Investigators

  • michele ulivi · IRCCS Istituto Ortopedico GaleazziMilano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2019-12-31
Completion
2020-12-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04427657 on ClinicalTrials.gov