Actively Recruiting
Evaluation of an Injection of Autologous Microfat With Platelet-rich Plasma Versus Total Wrist Denervation for Radiocarpal Osteoarthritis: A Randomized Non-inferiority Trial
Led by Assistance Publique Hopitaux De Marseille · Updated on 2023-03-10
36
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment for people with radiocarpal osteoarthritis, a condition causing wrist pain and reduced function. This phase II trial compares the effectiveness of an injection combining a patient's own microfat and platelet-rich plasma (PRP) against the standard surgical treatment of total wrist denervation. The goal is to see if the injection is not less effective than surgery in reducing pain and improving wrist function. The study involves two groups: one receiving the intra-articular injection of autologous microfat and PRP during a half-day outpatient procedure that includes two surgical steps and preparation time; the other undergoing total wrist denervation surgery as a one-day outpatient procedure with loco-regional anesthesia. Both treatments aim to relieve pain and improve wrist function in patients resistant to medical treatments. Participants will be followed and evaluated with pain assessments using a visual analog scale at 7 days, 3 months, 6 months, and 1 year. Additional measures include wrist function scores, strength tests, joint movement, patient satisfaction, and MRI scans to assess cartilage improvements. Safety and adverse events will be monitored throughout. The main outcome is pain reduction at 6 months, with total participation lasting up to one year.
CONDITIONS
Brief 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
- Diagnosed wrist osteoarthritis confirmed by radiographs or arthroscanner
- Symptomatic with pain of at least 40 mm on a 0-100 mm visual analog scale
- Reduced wrist strength or mobility causing daily discomfort and impaired quality of life
- Medical treatment for wrist osteoarthritis attempted for at least one year without sufficient relief
- Signed informed consent form
- Women of childbearing age must have a negative pregnancy test and use reliable contraception
- 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
- Current or recent oral corticosteroid treatment or injections within 2 months
- NSAIDs taken within 15 days before inclusion
- Recent fever or infection within one month
- Current or chronic infectious diseases or autoimmune diseases
- Inflammatory or microcrystalline arthritis
- Previous surgery for wrist osteoarthritis including total denervation or arthrodesis
- Immune deficiency or malignant tumors under treatment or within the past 5 years
- Contraindications to MRI or local anesthesia
- Positive tests for active infections such as HIV, hepatitis, or syphilis
- Body mass index less than 18 kg/m2
- Coagulation disorders or anemia contraindicating treatment
- Pregnant or breastfeeding women
- Persons under guardianship or trusteeship
- Participation in another clinical trial or exclusion period
- Persons in emergency situations, deprived of liberty, or not covered by social security
- Refusal or inability to give informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of treatment
Participants receive either an intra-articular injection of autologous microfat combined with platelet-rich plasma during a half-day outpatient procedure or total wrist denervation surgery during a one-day outpatient stay. Both treatments aim to reduce pain and improve wrist function.
1 treatment visit (in-person)
Duration - Up to 12 months
Participants are monitored to assess safety, pain, wrist function, and satisfaction following their treatment.
Visits at Day 7, 3 months, 6 months, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Assistance Publique Hôpitaux Marseille
Marseille, Bouches-du-Rhône, France, 13354
Actively Recruiting
Research Team
A
Alice MAYOLY
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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