Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis
Recruiting · NCT05378841 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Rheumatology department Saint-Antoine Hospital - Paris, France