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
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.
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
Parallel
Intra-articular injection of microfat and PRP
DrugThe treatment by intra-articular injection of autologous microfat and PRP will be performed during a half-day outpatient stay in the hand and limb repair surgery department at the Hôpital de la Timone. The total duration of the procedure is approximately 4 hours and includes 2 surgical times performed in the operating room and an intermediate waiting time for the patient in an outpatient room during the preparation of the experimental products.
Total denervation of the wrist
Procedure/SurgeryThe surgical treatment by total denervation of the wrist will be performed during a one-day outpatient stay in the hand and limb surgery department at the Hôpital de la Timone. It will be performed under loco-regional anesthesia by axillary plexus block.
Pain intensity measured on the visual analog scale (EVA)
The patient will indicate his or her pain using a cross on a 10 cm scale called the VAS score. The VAS is rated from 0 to 100 by the evaluator. The higher the patient's score, the greater the pain.
Pain intensity measured on the visual analog scale (EVA)
The patient will indicate his or her pain using a cross on a 10 cm scale called the VAS score. The VAS is rated from 0 to 100 by the evaluator. The higher the patient's score, the greater the pain.
Combined assessment of function and pain by the PRWE score
The PRWE (Patient-Rated Wrist Evaluation) is a specific wrist function and pain assessment score. The questionnaire consists of 15 items, 5 of which focus on pain (50 points) and 10 on wrist function (100 points). We will use the combined score in which the total points for wrist function are divided by 2 and added to the pain score to obtain a total score out of 100 points.
Assessment of upper limb function by the DASH score
The DASH (Disabilities of the Arm, Shoulder and Hand) is a subjective self-assessment questionnaire of the overall functional capacity of both upper limbs. The questionnaire consists of 30 questions covering difficulty with specific activities of daily living, social relationships, and specific symptoms: pain, strength, mobility and sleep. The overall score is presented as a score out of 100 by the following calculation method: \[(sum of n responses)-1\] x 25n. The score is only valid if 90% of the questions have been filled in by the patient (i.e. 3 missing values at most).
Assessment of wrist strength by dynamometry
Wrist grip strength will be assessed by the average score of 3 consecutive measurements on the Jamar hydraulic hand dynamometer.
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