Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis

Osteoarthritis Hand Clinical Trial

— DECAD  

Official title:

Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378841
• Other study ID #: APHP211437
• Secondary ID: 2022-A00794-39
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Adeline CAMBON-BINDER, MD PhD
• Phone: 685573795
• Email: adeline.cambonbinder[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 and radiographically osteoarthritic (Kellgren-Lawrence radiographic score = 2

• without mobility arc deficit greater than 40°

• 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.

• Several painful joints requiring simultaneous intervention on several rays

• 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 3 months

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Hand

Intervention

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

Locations

Country	Name	City	State
France	Rheumatology department Saint-Antoine Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain at 6 months	Assessement with Numerical pain scale of the operated finger and the operated hand (from 0 to 10)	6 months
Secondary	Quality of life at 6 months : Score quick-DASH	Calculation of score by quick-DASH questionnary: main functional and quality of life and function score used in hand surgery	6 months
Secondary	Quality of life at 6 months : Score AUSCAN	Calculation of score by AUSCAN questionnary (Australian/Canadian Osteo Arthritis Hand Index, self-administered questionnaire validated in AD measuring pain, function and stiffness)	6 months
Secondary	Grip strength at 6 months	Grip strength measured by JAMAR hydraulic dynamometer to assess the impact of pain on function	6 months
Secondary	PGI-C Score at 6 months	Calculation of score on PGI-C scale (Patient Global Impressions scale-Change, assesses the perception of a change induced by the treatment) to assess patient satisfaction	6 months