Treatment of wrist osteoarthritis using fat and plasma injections

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 study is testing if injections of fat and plasma can help people with wrist osteoarthritis feel less pain compared to the usual surgery for this condition.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (Academic / other)
• Locations: 1 site (Marseille, Bouches-du-Rhône)
• Trial ID: NCT05501743 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates the efficacy of intra-articular injections of autologous microfat combined with platelet-enriched plasma (PRP) for patients with radiocarpal osteoarthritis. It is a randomized controlled non-inferiority trial comparing this treatment to total wrist denervation, which is the established standard. The primary outcome is pain reduction measured by the visual analog scale (VAS) at six months, while secondary outcomes include safety assessments, patient satisfaction, and MRI evaluations of cartilage health. The study aims to determine if the new treatment is as effective as the standard approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic wrist osteoarthritis and significant pain that has not responded to medical treatment.

Not a fit: Patients with non-symptomatic wrist osteoarthritis or those who have not experienced significant pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive alternative to total wrist denervation for patients suffering from wrist osteoarthritis.

How similar studies have performed: Other studies have shown promising results with similar approaches using autologous fat and PRP injections, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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
* Positive markers for the following active infectious diseases: HIV 1 and HIV 2 human immunodeficiency virus infection; HTLV I infection; Hepatitis B virus infection; Hepatitis C virus infection; Syphilis causative agent infection. (Order of November 4, 2014 on the screening of infectious diseases during autologous therapeutic samples provided for in Article R. 1211-22-1 of the Public Health Code and amending the order of May 14, 2010 setting the content of information allowing the use of human body elements and products for therapeutic purposes)
* Body mass index (BMI) less than 18kg/m2 not allowing to obtain a sufficient quantity of adipose tissue for the manufacturing of the experimental MTI-PP and exposing the patient to a significant discomfort during the liposuction procedure
* Coagulation disorders that may interfere with the quality or therapeutic effect of the investigational drug:
* Thrombocytopenia \< 150 G/L
* Thrombocytosis \> 450 G/L
* Known thrombopathy
* TP \< 70% o Patient/hematopoietic ratio
* Patient to Witness APTT ratio \> 1.20
* Anemia \< 10g/dl contraindicating peripheral venous blood sampling
* Pregnant or breastfeeding women
* Persons of legal age (under guardianship or trusteeship)
* Persons participating simultaneously in another research project involving the human person or in a period of exclusion from a previous research project
* Persons staying in a health or social institution
* Persons in an emergency situation
* Persons deprived of liberty
* Persons who are not beneficiaries of a social security system
* Absence or refusal to give informed consent to participate in the study

Where this trial is running

Marseille, Bouches-du-Rhône

• Assistance Publique Hôpitaux Marseille — Marseille, Bouches-du-Rhône, France (Recruiting)

Study contacts

• Principal investigator: Alice MAYOLY — Assistance Publique Hôpitaux Marseille
• Study coordinator: Alice MAYOLY

Conditions Arthrosis