radiocarpal osteoarthritis
Conditions
Interventions
Product Name: melange de Plasma Autologue riche en plaquette et de micrograisse autologue
Product Code: PRP et micrograisse
Pharmaceutical Form: Solution for injection
Sponsors
ASSITANCE PUBLIQUE HOPITAUX DE MARSEILLE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients of both gender, minimum age 18-year-old 2 Patient suffering from wrist osteoarthritis that must be: -Symptomatic: pain = 40 mm on the VAS (0 to 100 mm), associated or not with a loss of strength measured by the Jamar dynamometer and/or a loss of wrist mobility leading to discomfort in daily life activities and an impaired quality of life. -Shown on radiographs and arthroscan: stylo-scaphoid and/or global radiocarpal and/or scapho-capital and/or luno-capital joint pinch, associated or not with osteophytic and subchondral changes equivalent to a grade 3 of the Kellgren and Lawrence classification. Depending on the aetiology of the wrist osteoarthritis, the following findings may be identified: an adaptive carpal defect (DISI: Dorsal intercalated segmental instability), 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 another carpal bone. -Not responding to medical treatment for at least 1 year: painkillers of the appropriate level, non-steroidal anti-inflammatory drugs, wearing of an analgesic brace, rehabilitation by a physiotherapist +/- intra-articular injections of corticoids or hyaluronic acid. 3 Informed consent form must be signed by the patient 4 Women of childbearing age must have a negative pregnancy test (serum or urine) (detection threshold (sensitivity): 25 mIU hCG/ml). Patients of both genders must use reliable contraception. 5 Beneficiaries or members of the French social security scheme Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 1. Use of antiplatelet agents, aspirin, or anti-vitamin K drugs less than 15 days prior to inclusion that may interfere with the quality or therapeutic effect of the treatment under study 2. Chronic treatment with oral corticosteroids or the use of such treatment less than 2 weeks prior to inclusion 3. Intra-articular corticosteroid injection less than 2 months prior to inclusion 4. Intra-articular injection of hyaluronic acid less than 2 months prior to inclusion 5. Non-steroidal anti-inflammatory drugs less than 15 days prior to inclusion 6. Fever or recent infection (bacterial or viral) less than one month prior to inclusion 7. Current or chronic infectious diseases (viral or bacterial) identified by clinical and/or biological evidence (inflammatory marker: ESR, CRP, Fibrinogen) 8. Autoimmune diseases attested by clinical and/or biological evidence (inflammatory marker: ESV, CRP, fibrinogen) that may interfere with the quality or therapeutic effect of the drug under study 9. Inflammatory arthritis 10. Microcrystalline arthritis 11. History of surgery for treatment of wrist osteoarthritis: total wrist denervation, first row carpal resection, arthrodesis, arthroplasty 12. Congenital or acquired immune deficiency 13. Malignant tumours or history of malignant tumours less than 5 years prior to inclusion 14. 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), orthopaedic medical prosthetics. 15. Contraindications to local anaesthetics drugs 16. Contraindications to local anaesthesia or surgery 17. Positive markers for the following active infectious diseases: HIV 1 and HIV 2 human immunodeficiency virus infection; HTLV I virus infection; Hepatitis B virus infection; Hepatitis C virus infection; Syphilis causative agent infection. (Order of November 4, 2014 on screening for infectious diseases during autologous therapeutic samples provided for in Article R. 1211-22-1 of the French 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) 18. Body mass index (BMI) of less than 18 kg/m2 not allowing to obtain a sufficient quantity of adipose tissue for the manufacturing of the experimental “hospital exemption” and exposing the patient to a significant discomfort during the liposuction procedure 19. Coagulation disorders that may interfere with the quality or therapeutic effect of the drug under study: Thrombocytopenia 450 G/L, known thrombopathy, PT 1.20, anaemia < 10g/dl contraindicating peripheral venous blood sampling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority in terms of efficiency of intra-articular injection of autologous microfat and PRP in patients suffering from radiocarpal osteoarthritis resistant to medical treatment on pain evaluated by the visual analog scale (VAS) at 6 months in comparison with total wrist denervation (established standard treatment);Secondary Objective: -Assess the safety of the treatment under study at D7, M3, M6, M12, compared to the established standard treatment group by monitoring adverse events and post-operative follow-up data. -To assess the non-inferiority of the treatment under study compared to the established standard treatment on the secondary efficacy endpoints: At M3, M6 and M12: ?PRWE functional score (non-inferiority limit: 11.5 points) ?DASH functional score (non-inferiority limit: 10.83 points), ?Strength measured by the Jamar dynamometer (non-inferiority limit: 6.5kg). At M3 and M12 ?Intensity of pain measured by the VAS (limit: 14mm). -To evaluate the efficiency of the treatment under study at M3, M6 and M12: ?Wrist joint ranges, ?Patients' Global Impression of Change (PGIC) -Evaluate patient satisfaction at D7 and M3. ;Primary end point(s): pain intensity measured on the VAS;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of upper limb function by the DASH score Assessment of wrist strength by dynamometry;Timepoint(s) of evaluation of this end point: 3 months, 6months and 12 months | — |
Countries
France
Contacts
Public ContactALEXANDRA GIULIANI
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Outcome results
None listed