Status:
COMPLETED
Intra Articular Injection of Microfat and PRP in Knee Osteoarthritis
Lead Sponsor:
Clinique Juge
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical tr...
Detailed Description
Osteoarthritis is the most common joint disease in the world and one of the most common causes of pain and functional disability. The incidence of cartilage pathology has grown due to the ageing popul...
Eligibility Criteria
Inclusion
- Males and females between 20 to 65 years of age
- Symptomatic knee osteoarthritis , ICRS grade 2, 3 ou 4 with VAS \> 4 and failure of medical treatment for at least one year
- BMI between 20 to 30
- Written informed consent, signed by patient or legal representative
- HB \> 10g/dl
- Negative pregnancy test
- Social security affiliated
Exclusion
- IRM contre-indications: ocular loose bodies, pace maker, neurostimulateur, cochlear implant, vascular clips, mettalic cardiac valve
- BMI \< 20
- Thrombocytopenia \< 150 G/L
- Thrombocytosis \> 450 G/L
- Thrombopathy
- TP \< 70%
- TCA patient / witness rapport \> 1,20
- Anaemia: HB \< 10g/dl
- Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
- Treatment by platelet inhibiting agent, aspirin, anti vitamin K completed more than 2 weeks before inclusion
- Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
- Intra articular knee injection of corticosteroid more than 8 weeks before inclusion
- Intra articular knee injection of hyaluronic acid more than 8 weeks before inclusion
- NSAI treatment completed more than 2 weeks before inclusion
- Fever or recent disease
- Auto immune disease
- Inflammatory Arthritis
- Immune deficit
- Infectious disease
- Malignant tumor being treated or history of malignant tumor
Key Trial Info
Start Date :
November 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04352075
Start Date
November 15 2018
End Date
March 1 2020
Last Update
April 20 2020
Active Locations (1)
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1
Louis
Marseille, France, 13008