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.
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.
• Men and women aged ≥ 18 years
• Patients with wrist osteoarthritis:
• Symptomatic: pain ≥ 40 mm on the visual analog scale (VAS 0-100 mm) more or less associated with a loss of strength objectified by the Jamar dynamometer and/or wrist mobility leading to discomfort in activities of daily living and impaired quality of life.
• Objectivated on radiographs and arthroscanner: stylo-scaphoid and/or global radiocarpal and/or scapho-capital and/or luno-capital joint pinch, more or less associated with osteophytic and subchondral changes equivalent to a grade 3 of the Kellgren and Lawrence classification (see chapter I). Depending on the etiology of the wrist osteoarthritis, the following may be associated: an adaptive carpal defect (DISI), a rupture of the scapholunate or pisotiquetral ligaments, a pseudarthrosis of the scaphoid, a necrosis of the proximal pole of the scaphoid, a vicious callus of the radius, or an avascular necrosis of one of the carpal bones.
• In case of failure of medical treatment for at least one year: analgesics of the appropriate level for the pain, NSAIDs, wearing of an analgesic orthosis, rehabilitation by a physiotherapist +/- intra-articular injections of corticoids or hyaluronic acid.
• Informed consent form signed by the patient
• Women of childbearing age must have a negative pregnancy test (serum or urine) (detection threshold (sensitivity): 25 mIU hCG/ml). Patients of both sexes must use reliable contraception.
• Beneficiaries or members of a social security system