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).

ConditionArthrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

Qualifiers

Men and women aged ≥ 18 years

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.

Disqualifiers

Use of antiplatelet drugs, aspirin, anti vitamin K drugs less than 15 days prior to inclusion that may interfere with the quality or therapeutic effect of the investigational drug

Chronic treatment with oral corticosteroids or less than 2 weeks old

Intra-articular corticoid injection less than 2 months old

Intra-articular injection of hyaluronic acid less than 2 months old

Trial design

Treatments tested in this trial

  • Intra-articular injection of microfat and PRP
  • Total denervation of the wrist

Treatment groups

36 Participants
are divided into 2 treatment groups