Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.

NCT06084637 | Not Yet Recruiting Phase 3

• 1 other identifier: RCAPHM21_0431
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research protocol evaluate the efficacity of intra-articular injections of autologous microfat associated with a preparation of autologous PRP, in symptomatic, resistant to first-line medical treatment, degenerative or post-traumatic cartilage lesions of the knee. The primary objective of this study is to show the superiority of intra-articular injection of autologous microfat combined with autologous PRP preparation compared to injection of microfat or PRP used alone, on the KOOS score at 6 months.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• KOOS score at 6 months

  KOOS assesses the short- and long-term consequences of knee injuries, as well as the consequences of primary osteoarthritis. It is percentage from 0 to 100. 0 represents extreme problems and 100 represents no problem.

  6 months

Secondary Outcomes (8)

• Pain at 1 month

  1 month

• Pain at 3 months

  3 months

• Pain at 12 months

  12 months

• KOOS score at 1 month

  1 month

• KOOS score at 3 months

  3 months

Study Arms (3)

autologous microfat (MG)

EXPERIMENTAL

Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous MG will be injected intra-articularly by th same surgeon.

Biological: Intra-articular injection of autologous microfat

Platelet-rich plasma (PRP)

EXPERIMENTAL

Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed under local anesthesia during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and a preparation of autologous PRP will be injected intra-articularly by th same surgeon.

Biological: Intra-articular injection of autologous platelet-rich plasma

Microfat autologous-Platelet-rich plasma (MG-PRP)

EXPERIMENTAL

Patient will be hospitalized in outpatient surgery. A blood sample will be collected and a lipoaspiration will be performed for the preparation during the same operation by the nurses and the surgeon. Then, biological products will be immediately prepared, and autologous microfat associated with a preparation of autologous PRP will be injected intra-articularly by th same surgeon.

Biological: Intra-articular injection of autologous microfat and platelet-rich plasma

Interventions

Intra-articular injection of autologous microfat BIOLOGICAL

A preparation of autologous microfat (5mL) will be injected intra-articularly.

autologous microfat (MG)

Intra-articular injection of autologous platelet-rich plasma BIOLOGICAL

A preparation of autologous platelet-rich plasma (5mL) will be injected intra-articularly.

Platelet-rich plasma (PRP)

Intra-articular injection of autologous microfat and platelet-rich plasma BIOLOGICAL

A preparation of autologous platelet-rich plasma (5mL) and autologous microfat (5mL) will be injected intra-articularly.

Microfat autologous-Platelet-rich plasma (MG-PRP)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both gender, between 20 and 75 year-old.
• Symptomatics degenerativ or post traumatic chondropathy, on at least one of the 3 knee compartments ICRS grade 2, 3 or 4 with VAS\>4 and failure of well-conducted medical treatment for at least 1 year (palliative analgesics adapted to the pain, AINS, rehabilitation by a physiotherapist, injections intra-articulaires de corticoïdes et/ou d'acide hyaluronique)
• Varus or valgus less than or equal to 5°.
• BMI greater than 20 (in order to have sufficient fatty tissue)
• Informed consent signed by the patient
• HB \> 10g/dl
• Beneficiaries of or affiliated to a social security system

You may not qualify if:

• Contraindications to MRI : ocular foreign bodies, pacemaker, neurostimulator, cochlear implant, vascular clips, metallic heart valve
• Body mass index (BMI) of less than 20 kg/m2 not allowig to obtain a sufficient quantity of adipose tissue.
• Thrombocytopenia \< 150 G/L
• Thrombocytosis \> 450 G/L
• Known thrombopathy
• TP=\> PR \< 70%.
• TCA=\> APR \> 1.20s
• Anemia HB \< 10g/dl
• Positive markers for the following active infectious diseases: HIV 1 and HIV 2 human immunodeficiency virus infection; HTLV I and II virus infection; Hepatitis B virus infection; Hepatitis C virus infection; Syphilis causative agent infection.
• Use of antiplatelet agents, aspirin, anti-vitamin K drugs for less than 15 days.
• Recent fever or infection (bacterial or viral) less than one month old
• Autoimmune diseases
• Inflammatory arthritis
• Immune deficiency
• Ongoing or chronic infectious diseases (viral or bacterial)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Central Study Contacts

Alexandre ROCHWERGER, Pr

CONTACT

04 91 96 63 00; richardalexandre.rochwerger@ap-hm.fr

Alexandra GIULIANI

CONTACT

0491382870; alexandra.giuliani@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: February 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 27, 2023

Record last verified: 2023-10