Clinical trial NCT05378841: Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis
Official title: Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Hand
Keywords: Digital osteoarthritis
Surgical joint dernervation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Success of the intervention at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Pain at 6 months
timeFrame: 6 months
measure: Quality of life at 6 months : Score quick-DASH
timeFrame: 6 months
measure: Quality of life at 6 months : Score AUSCAN
timeFrame: 6 months
measure: Grip strength at 6 months
timeFrame: 6 months
measure: PGI-C Score at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Rheumatology department Saint-Antoine Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jérémie SELLAM
role: PRINCIPAL_INVESTIGATOR
References: