Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis (DECAD)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Osteoarthritis Hand

Treatments: Procedure: Surgical Denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT05378841

APHP211437

2022-A00794-39 (Other Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Surgical denervation

Experimental group

Description:

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.

Treatment:

Procedure: Surgical Denervation