Surgical joint denervation for painful digital osteoarthritis

Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis

This study tests if a surgery that cuts nerves in the hands can help people with painful osteoarthritis feel less pain and move better when other treatments haven't worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Paris)
• Trial ID: NCT05378841 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of surgical joint denervation as a treatment for painful digital osteoarthritis, a condition characterized by severe pain and functional impairment in the hands. The study focuses on patients with symptomatic osteoarthritis who have not responded to conventional medical treatments. By cutting the nerve branches supplying the affected joints, the trial aims to alleviate pain and improve function. The study is prospective and aims to gather data on the outcomes of this surgical intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic digital osteoarthritis who have experienced pain in a proximal interphalangeal joint for over three months and have not found relief from standard treatments.

Not a fit: Patients with digital osteoarthritis caused by other conditions or those with contraindications to surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide significant pain relief and improved function for patients suffering from digital osteoarthritis.

How similar studies have performed: While surgical denervation is a less common approach, similar studies exploring nerve-related interventions for pain management have shown promise, suggesting potential for success in this novel application.

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.

Where this trial is running

Paris

• Rheumatology department Saint-Antoine Hospital — Paris, France (Recruiting)

Study contacts

• Principal investigator: Jérémie SELLAM — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Adeline CAMBON-BINDER, MD PhD

Conditions Osteoarthritis Hand; Digital osteoarthritis; Surgical joint dernervation