Status:
NOT_YET_RECRUITING
Comparison Between Intra-articular Infiltrations of PRP, MFAT, and PRP-MFAT in the Treatment of Symptomatic Knee Osteoarthritis.
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
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 tre...
Detailed Description
Osteoarthritis is the most widespread joint disease in the world, and one of the most frequent causes of pain and functional disability in Western countries. The incidence of cartilage lesions is cons...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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
- 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)
- T Malignant tumours or history of malignant tumours less than 5 years prior to inclusion
- 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
- Contraindication to local anesthesia and/or surgery
- Allergy to local anesthetics
- Inmates
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06084637
Start Date
February 2 2024
End Date
March 1 2028
Last Update
October 27 2023
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