Use of Lipogems for Knee Osteoarthritis

NCT04427657 | Completed

• 1 other identifier: LipoOA
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups

  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®).

  6 month

Secondary Outcomes (3)

• Radiological changes at 6 month recorded between the two groups

  6 month

• Functional changes at 6 month recorded between the two groups

  6 month

• Serum changes at 6 month recorded between the two groups

  6 month

Study Arms (2)

Controls

ACTIVE COMPARATOR

39 patients with knee osteoarthritis undergoing arthroscopic debridement

Procedure: arthroscopic debridment

Cases

EXPERIMENTAL

39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®).

Procedure: autologous microfragmented lipoaspirate tissue (Lipogems®).

Interventions

autologous microfragmented lipoaspirate tissue (Lipogems®). PROCEDURE

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.

Cases

arthroscopic debridment PROCEDURE

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

Controls

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• michele ulivi

  IRCCS Istituto Ortopedico GaleazziMilano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: June 11, 2020
• Study Start: November 8, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 1, 2020
• Last Updated: July 6, 2021

Record last verified: 2020-12

Locations

IT (2)