Efficacy of Surgical Joint Denervation in Painful Digital Osteoarthritis
ConditionOsteoarthritis Hand
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Surgical Denervation
Procedure/SurgeryThis is an outpatient procedure performed under local anesthesia (depending on the anesthesiologist's decision), which lasts about 30 minutes.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: Surgical denervationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
3 monthsSecondary outcomes
1
Pain at 6 months
Assessement with Numerical pain scale of the operated finger and the operated hand (from 0 to 10)
Time frame
6 months2
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
Time frame
6 months3
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)
Time frame
6 months4
Grip strength at 6 months
Grip strength measured by JAMAR hydraulic dynamometer to assess the impact of pain on function
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov