Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease

Not Applicable

Completed

• Conditions: Dupuytren Disease
• Interventions: Procedure: Percutaneous aponeurotomy

• Registration Number: NCT02474576
• Lead Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-17
• Study Start: 2015-09
• Primary Completion: 2019-04
• Study Completion: 2020-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Percutaneous aponeurotomy	Percutaneous aponeurotomy	Treatment of Dupuytrens-induced finger flessum using percutaneous aponeurotomy

Primary Outcome Measures

Name	Time	Method
Frequency of local relapse at 24 months	24 months after treatment by aponeurotomy	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

Secondary Outcome Measures

Name	Time	Method
Frequency of local relapse at 60 months	60 months after treatment by aponeurotomy
Primary success rate of aponeurotomy	3 months after treatment	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°
Frequency of local relapse at 48 months	48 months after treatment by aponeurotomy
Frequency of local relapse at 12 months	12 months after treatment by aponeurotomy
Frequency of local relapse at 36 months	36 months after treatment by aponeurotomy

Trial Locations

Locations (1)

Diaconesses Croix Saint-Simon Hospital Group; 🇫🇷 Paris, France