Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis

NCT05378841 | Recruiting

• 2 other identifiers: APHP2114372022-A00794-39
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Hand

Keywords

Digital osteoarthritis; Surgical joint dernervation

Outcome Measures

Primary Outcomes (1)

• Success of the intervention at 3 months

  Success of the intervention at 3 months, defined by a reduction in pain of at least 2 points compared to the measurement at inclusion, with the numerical painscale (from 0 to 10) for the operate finger

  3 months

Secondary Outcomes (5)

• Pain at 6 months

  6 months

• Quality of life at 6 months : Score quick-DASH

  6 months

• Quality of life at 6 months : Score AUSCAN

  6 months

• Grip strength at 6 months

  6 months

• PGI-C Score at 6 months

  6 months

Study Arms (1)

Surgical denervation

EXPERIMENTAL

It consists of a section of the nerve branches destined for the PIPJ, coming from the digital collateral nerves as well as the dorsal sensory branches of the radial and ulnar nerves respectively for the index and fifth fingers.

Procedure: Surgical Denervation

Interventions

Surgical Denervation PROCEDURE

This is an outpatient procedure performed under local anesthesia (depending on the anesthesiologist's decision), which lasts about 30 minutes.

Surgical denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients with symptomatic digital osteoarthritis according to the criteria of the American College of Rheumatology
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Rheumatology department Saint-Antoine Hospital

Paris, 75012, France

RECRUITING

Study Officials

• Jérémie SELLAM

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeline CAMBON-BINDER, MD PhD

CONTACT

685573795; adeline.cambonbinder@aphp.fr

Jérémie SELLAM

CONTACT

+ 33 1 49 28 25 20; jeremie.sellam@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 18, 2022
• Study Start: June 5, 2023
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

FR (1)