Overview

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 Dene

Status:
Not yet recruiting
Trial end date:
2026-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
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