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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Assistance Publique Hôpitaux Marseille
RECRUITING
Marseille
Contact Information
Primary
Alice MAYOLY
alice.mayoly@ap-hm.fr
0413429283
Time Frame
Start Date: 2023-02-17
Estimated Completion Date: 2026-06
Participants
Target number of participants: 36
Treatments
Experimental: Study treatment group (T)
The 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.
Active_comparator: Reference treatment group (R)
The 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.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov