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).

NCT05501743 | Recruiting Phase 2

• 1 other identifier: 2021-006817-12
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (8)

• Pain intensity measured on the visual analog scale (EVA)

  Day 7, 3 Months and 1 Year

• Combined assessment of function and pain by the PRWE score

  3 Months, 6 Months and 1 Year

• Assessment of upper limb function by the DASH score

  3 Months, 6 Months and 1 Year

• Assessment of wrist strength by dynamometry

  3 Months, 6 Months and 1 Year

• Measurement of wrist joint amplitudes

  3 Months, 6 Months and 1 Year

Study Arms (2)

Study treatment group (T)

EXPERIMENTAL

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.

Drug: Intra-articular injection of microfat and PRP

Reference treatment group (R)

ACTIVE COMPARATOR

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.

Procedure: Total denervation of the wrist

Interventions

Intra-articular injection of microfat and PRP DRUG

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.

Study treatment group (T)

Total denervation of the wrist PROCEDURE

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.

Reference treatment group (R)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• NSAIDs taken less than 15 days ago
• Recent fever or infection (bacterial or viral) less than one month old
• Current or chronic infectious diseases (viral or bacterial) as evidenced by clinical and/or biological elements (inflammatory work-up: VS, CRP, Fibrinogen)
• Autoimmune diseases attested to by questioning, or clinical and/or biological elements (inflammatory workup: VS, CRP, fibrinogen) and which may interfere with the quality or therapeutic effect of the investigational drug
• Inflammatory arthritis
• Microcrystalline arthritis
• History of surgery for the treatment of osteoarthritis of the tested wrist: total denervation of the wrist, resection of the first row of the carpus, arthrodesis, arthroplasty
• Congenital or acquired immune deficiency
• Malignant tumors under treatment or history of malignant tumors less than 5 years old
• Contraindications to MRI: metallic foreign bodies (ferromagnetic material) and metallic implants (pacemakers, heart valves, vascular clips, surgical clips or staples, cochlear implants, any implanted electronic medical material or device (e.g. insulin pump), orthopedic medical prostheses.
• Contraindications to local anesthetics.
• Contraindications to local anesthesia or surgery

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux Marseille

Marseille, Bouches-du-Rhône, 13354, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• François CREMIEUX

  Assistance Publique Hôpitaux Marseille

  STUDY DIRECTOR

• Alice MAYOLY

  Assistance Publique Hôpitaux Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice MAYOLY

CONTACT

0413429283; alice.mayoly@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will be balanced in 2 parallel groups : * Patients in the "study treatment" group (T) will receive an intra-articular injection of microfat and PRP. * Patients in the "reference treatment" group (R) will undergo total wrist denervation surgery.

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 15, 2022
• Study Start: February 17, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

FR (1)