Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis

NCT ID: NCT05378841

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2026-06-15

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.

Detailed Description

Osteoarthritis is the most common joint pathology of the musculoskeletal system. It affects 6 million French people and constitutes a public health problem. Osteoarthritis of the hands or digitalis is the second localization of symptomatic osteoarthritis, after the knee. Its main risk factors are female sex, age, genetic factors, and obesity.

Osteoarthritis combines articular cartilage degradation, synovial inflammation, subchondral bone remodeling and osteophyte development. Its cardinal symptoms are pain and functional impairment (at a level sometimes close to inflammatory rheumatism such as rheumatoid arthritis), particularly intense in the case of the erosive form. There is also local joint inflammation associated with pain. Pain in osteoarthritis is a complex phenomenon involving joint tissues other than cartilage, a tissue that is not innervated (subchondral bone, joint capsule, synovial membrane).

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.

The only current conservative surgical solution that can be proposed for intractable painful proximal interphalangeal joint (PIPJ) osteoarthritis is denervation. This technique consists of cutting the nerve branches intended for the PIPJ in order to directly interrupt the pain pathways. It reduces pain by 80% after 5 years, without loss of mobility. There are only 4 published series reporting the results of this technique (2-3). These were retrospective case series with a low level of evidence. The patient satisfaction rate reached 90%, with transient paresthesias as the only reported complication. The mechanism of action for the effectiveness of this intervention has never been studied.

Our hypothesis is that denervation of the PIP has clinical efficacy in painful digital osteoarthritis refractory to usual treatments, and that it would have a structural effect that can be objectified on MRI.

The results of this pilot study will make it possible to construct a prospective randomized study.

Conditions

Osteoarthritis Hand

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Surgical denervation

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.

Group Type: EXPERIMENTAL

Surgical Denervation

Intervention Type: PROCEDURE

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

Interventions

Surgical Denervation

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérémie SELLAM

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Rheumatology department Saint-Antoine Hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Adeline CAMBON-BINDER, MD PhD

Role: CONTACT

adeline.cambonbinder@aphp.fr

685573795 ext. +33

Jérémie SELLAM

Role: CONTACT

jeremie.sellam@aphp.fr

+ 33 1 49 28 25 20

Facility Contacts

Jérémie Sellam, Md PhD PU-PH

Role: primary

jeremie.sellam@aphp.fr

+ 33 1 49 28 25 20

Other Identifiers

2022-A00794-39

Identifier Type: OTHER

Identifier Source: secondary_id

APHP211437

Identifier Type: -

Identifier Source: org_study_id