Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease (APADUP)

February 10, 2021 updated by: Groupe Hospitalier Diaconesses Croix Saint-Simon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75020
        • Diaconesses Croix Saint-Simon Hospital Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Percutaneous aponeurotomy
Treatment of Dupuytrens-induced finger flessum using percutaneous aponeurotomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of local relapse at 24 months
Time Frame: 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
24 months after treatment by aponeurotomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary success rate of aponeurotomy
Time Frame: 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°
3 months after treatment
Frequency of local relapse at 12 months
Time Frame: 12 months after treatment by aponeurotomy
12 months after treatment by aponeurotomy
Frequency of local relapse at 36 months
Time Frame: 36 months after treatment by aponeurotomy
36 months after treatment by aponeurotomy
Frequency of local relapse at 48 months
Time Frame: 48 months after treatment by aponeurotomy
48 months after treatment by aponeurotomy
Frequency of local relapse at 60 months
Time Frame: 60 months after treatment by aponeurotomy
60 months after treatment by aponeurotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (ESTIMATE)

June 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMN_2015-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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