Use of Lipogems for Knee Osteoarthritis

NCT ID: NCT04427657

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-08
• Study Completion Date: 2020-12-01

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Controls

39 patients with knee osteoarthritis undergoing arthroscopic debridement

Group Type: ACTIVE_COMPARATOR

arthroscopic debridment

Intervention Type: PROCEDURE

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

Cases

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

Group Type: EXPERIMENTAL

autologous microfragmented lipoaspirate tissue (Lipogems®).

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

arthroscopic debridment

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

michele ulivi

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico GaleazziMilano

Locations

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Istituto Ortopedico Galeazzi

Milan, , Italy

Countries

Italy

Other Identifiers

LipoOA

Identifier Type: -

Identifier Source: org_study_id