Actively Recruiting
Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation (Established Standard Treatment).
Led by Assistance Publique Hopitaux De Marseille · Updated on 2023-03-10
36
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, prospective, comparative, randomized, single-center, open-label, parallel-group therapeutic trial. It is a non-inferiority trial to establish the efficacy of intra-articular injection of autologous microfat and PRP at the wrist in patients suffering from radiocarpal osteoarthritis in reference to wrist denervation.
CONDITIONS
Official Title
Evaluation of the Efficacy of an Intra-articular Injection of Autologous Microfat Combined With Autologous Platelet-enriched Plasma in the Treatment of Radiocarpal Osteoarthritis: a Randomized Controlled Non-inferiority Trial Versus Total Wrist Denervation (Established Standard Treatment).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Wrist osteoarthritis confirmed by radiographs or arthroscanner involving specific joints and possible associated conditions
- Symptomatic wrist osteoarthritis with pain of at least 40 mm on the visual analog scale and possible loss of strength or mobility affecting daily activities
- Failure of medical treatment for at least one year including analgesics, NSAIDs, orthosis, rehabilitation, or prior intra-articular injections
- Signed informed consent
- Negative pregnancy test for women of childbearing age and use of reliable contraception for all participants
- Beneficiary or member of a social security system
You will not qualify if you...
- Use of antiplatelet drugs, aspirin, or anti-vitamin K drugs within 15 days before inclusion
- Chronic or recent oral corticosteroid treatment
- Intra-articular corticoid or hyaluronic acid injections less than 2 months old
- NSAIDs taken within 15 days before inclusion
- Fever or infection less than one month old
- Current or chronic infections or autoimmune diseases that may affect treatment
- Inflammatory or microcrystalline arthritis
- Previous surgery for wrist osteoarthritis including denervation, resection, arthrodesis, or arthroplasty
- Immune deficiency or malignant tumors under treatment or within 5 years
- Contraindications to MRI, local anesthesia, or surgery
- Positive tests for active infectious diseases including HIV, HTLV I, hepatitis B or C, syphilis
- Body mass index under 18 kg/m2
- Coagulation disorders or anemia contraindicating blood sampling
- Pregnant or breastfeeding women
- Legal incapacity or guardianship
- Participation in another research project or exclusion period
- Residency in health or social institution, emergency situation, or deprived of liberty
- Not a beneficiary of a social security system
- Refusal or absence of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Assistance Publique Hôpitaux Marseille
Marseille, Bouches-du-Rhône, France, 13354
Actively Recruiting
Research Team
A
Alice MAYOLY
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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