NCT05378841 Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis
| NCT ID | NCT05378841 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Osteoarthritis Hand |
| Study Type | INTERVENTIONAL |
| Enrollment | 19 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2026-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 19 participants in total. It began in 2023-06-05 with a primary completion date of 2026-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Digital osteoarthritis is the second localization of symptomatic osteoarthritis, after the knee. Its cardinal symptoms are particularly intense pain and functional impairment in the case of the erosive form. There is currently no etiological treatment for osteoarthritis. Symptomatic treatments have a modest efficacy, which justifies the search for new treatments. The surgical options are arthrodesis or prosthesis, invasive techniques potentially sources of complications, and finally proposed infrequently given the prevalence of digital osteoarthritis. DECAD is a prospective phase II trial aimed at evaluating the efficacy of surgical joint denervation in painful digital osteoarthritis.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Patients with symptomatic digital osteoarthritis according to the criteria of the American College of Rheumatology * 1 painful PIP joint (Analog digital scale ≥ 4/10) for more than 3 months * having failed the usual medical treatment for a minimum of 3 months (level 1 analgesics, NSAIDs, infiltrations) * Signature of informed consent * patient affiliated to a social security scheme * knowing how to read French (for the questionnaires) Exclusion Criteria: * digital osteoarthritis secondary to other known causes (eg gout, reactive arthritis, RA, psoriatic arthritis, spondyloarthropathies, septic arthritis) * anesthetic contraindications to surgery or to performing an MRI * Existence of a pain syndrome in the upper limbs, which would interfere with the assessment of AD. * Fibromyalgia * Use of oral, intramuscular or intra-articular or intravenous corticosteroids, immunosuppressants (methotrexate, sulfasalazine, leflunomide, biomedicines), hyaluronic acid infiltration in the finger joints in the previous month * Introduction of a new treatment for osteoarthritis of the hand in the previous month, including physiotherapy and fitting of a new finger orthosis. * History of denervation of the proximal interphalangeal joint (PIP) * Patient under legal protection (guardianship or curatorship) and patient deprived of liberty * Patient under AME * Participation in another interventional research involving the human person or period of exclusion at the end of a previous research involving the human person.
Contact & Investigator
Jérémie SELLAM
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05378841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis Hand. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05378841 currently recruiting?
Yes, NCT05378841 is actively recruiting participants. Contact the research team at adeline.cambonbinder@aphp.fr for enrollment information.
Where is the NCT05378841 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05378841 clinical trial?
NCT05378841 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Jérémie SELLAM at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 19 participants.