Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.
Key facts
- Who runs it
- Assistance Publique Hopitaux De Marseille
- Where
- Marseille and MARSEILLE, FranceSee the 4 sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 180 people, planned
- Started
- 2 Feb 2024
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional, 3 groups
- Treatments tested
- Intra-articular injection of autologous microfat
- Intra-articular injection of autologous platelet-rich plasma
- Intra-articular injection of autologous microfat and platelet-rich plasma
- Record updated
- 27 October 2023
Who can take part
- Age
- 20 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 39 criteriaShow less
Who can take part
- 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
- Negative beta-HCG at inclusion and effective contraception for patients of childbearing age, for 1 month
- Beneficiaries of or affiliated to a social security system
Who cannot take part
- Use of antiplatelet agents, aspirin, anti-vitamin K drugs for less than 15 days
- Chronic treatment with oral corticosteroids or the use of such treatment less than 2 weeks prior to inclusion
- Intra-articular corticosteroid injection less than 2 months prior to inclusion
- Intra-articular injection of hyaluronic acid less than 2 months prior to inclusion
- Non-steroidal anti-inflammatory drugs less than 15 days prior to inclusion
- Contraindication to local anesthesia and/or surgery
- Contraindications to MRI : ocular foreign bodies, pacemaker, neurostimulator, cochlear implant, vascular clips, metallic heart valve
- 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
- Recent fever or infection (bacterial or viral) less than one month old
- Autoimmune diseases
- Ongoing or chronic infectious diseases (viral or bacterial)
- T Malignant tumours or history of malignant tumours less than 5 years prior to inclusion
- Allergy to local anesthetics
- Thrombocytopenia < 150 G/L
- Thrombocytosis > 450 G/L
- Body mass index (BMI) of less than 20 kg/m2 not allowig to obtain a sufficient quantity of adipose tissue
- Known thrombopathy
- TP=> PR < 70%
- TCA=> APR > 1.20s
- Anemia HB < 10g/dl
- Inflammatory arthritis
- Immune deficiency
- Pregnant or lactating women
- Adults protected by law (guardianship or curatorship)
- Patient participating simultaneously in another research project involving the human person
- Minors
- Persons residing in a health or social institution
- Persons in emergency situations
- Persons deprived of liberty
- Persons not covered by the French social security scheme
- Inmates
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 75 years old?
Where in France
- Assistance Publique Hôpitaux de MarseilleMarseille, FranceTaking people
- Clinique JugeMarseille, FranceTaking people
- Hôpital Saint JosephMarseille, FranceTaking people
- clinique CHANTECLERMARSEILLE, FranceTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- autologous microfat (MG)Treatment being tested
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.
Treatment: Intra-articular injection of autologous microfat
- Platelet-rich plasma (PRP)Treatment being tested
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.
Treatment: Intra-articular injection of autologous platelet-rich plasma
- Microfat autologous-Platelet-rich plasma (MG-PRP)Treatment being tested
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.
Treatment: Intra-articular injection of autologous microfat and platelet-rich plasma
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Randomized Control Trial Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.
- Fit questions
- Built from NCT06084637, who can take part
- Record updated
- 27 October 2023