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

Primary Purpose

Osteoarthritis Hand

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgical Denervation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis Hand focused on measuring Digital osteoarthritis, Surgical joint dernervation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • Rheumatology department Saint-Antoine HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical denervation

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain at 6 months
Assessement with Numerical pain scale of the operated finger and the operated hand (from 0 to 10)
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
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)
Grip strength at 6 months
Grip strength measured by JAMAR hydraulic dynamometer to assess the impact of pain on function
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

Full Information

First Posted
April 15, 2022
Last Updated
June 28, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05378841
Brief Title
Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis
Acronym
DECAD
Official Title
Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Hand
Keywords
Digital osteoarthritis, Surgical joint dernervation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical denervation
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Surgical Denervation
Intervention Description
This is an outpatient procedure performed under local anesthesia (depending on the anesthesiologist's decision), which lasts about 30 minutes.
Primary Outcome Measure Information:
Title
Success of the intervention at 3 months
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain at 6 months
Description
Assessement with Numerical pain scale of the operated finger and the operated hand (from 0 to 10)
Time Frame
6 months
Title
Quality of life at 6 months : Score quick-DASH
Description
Calculation of score by quick-DASH questionnary: main functional and quality of life and function score used in hand surgery
Time Frame
6 months
Title
Quality of life at 6 months : Score AUSCAN
Description
Calculation of score by AUSCAN questionnary (Australian/Canadian Osteo Arthritis Hand Index, self-administered questionnaire validated in AD measuring pain, function and stiffness)
Time Frame
6 months
Title
Grip strength at 6 months
Description
Grip strength measured by JAMAR hydraulic dynamometer to assess the impact of pain on function
Time Frame
6 months
Title
PGI-C Score at 6 months
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeline CAMBON-BINDER, MD PhD
Phone
685573795
Ext
+33
Email
adeline.cambonbinder@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jérémie SELLAM
Phone
+ 33 1 49 28 25 20
Email
jeremie.sellam@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérémie SELLAM
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology department Saint-Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie Sellam, Md PhD PU-PH
Phone
+ 33 1 49 28 25 20
Email
jeremie.sellam@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis

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