Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease

Dupuytren Disease Clinical Trial

— APADUP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474576
• Other study ID #: MMN_2015-1
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 2020

Study information

• Verified date: February 2021
• Source: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known. This study aims primarily at measuring the incidence rate of local relapse of Dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in Dupuytrens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient suffers from Dupuytren disease
• Patient has at least one finger with at least 20° flessum on the metacarpophalangeal joint and/or on the proximal interphalangeal joint
• Patient has chosen to benefit from local treatment

Exclusion Criteria:

• Pregnancy
• Breastfeeding
• No social insurance

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren Disease

Intervention

Procedure:
• Percutaneous aponeurotomy
The finger(s) with limited extension due to Dupuytrens disease and for which the patient desires treatment, will be treated by fine-needle percutaneous aponeurotomy under local anesthesia (outpatient procedure). This procedure is already routinely used in clinical practice ; our study aims at better describing the time-sustainability of its benefits.

Locations

Country	Name	City	State
France	Diaconesses Croix Saint-Simon Hospital Group	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of local relapse at 24 months	the statistical unit is the finger treated by aponeurotomy (we expect an average of 2 fingers treated for one patient included). Local relapse is defined as the recurrence of a finger flessum superior by 20° to the articular range initially obtained after aponeurotomy	24 months after treatment by aponeurotomy
Secondary	Primary success rate of aponeurotomy	the statistical unit is the finger treated by aponeurotomy (we expect an average of 2 fingers treated for one patient included). Complete success is defined as a finger flessum inferior to 5°	3 months after treatment
Secondary	Frequency of local relapse at 12 months		12 months after treatment by aponeurotomy
Secondary	Frequency of local relapse at 36 months		36 months after treatment by aponeurotomy
Secondary	Frequency of local relapse at 48 months		48 months after treatment by aponeurotomy
Secondary	Frequency of local relapse at 60 months		60 months after treatment by aponeurotomy