Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease (APADUP)
Primary Purpose
Dupuytren Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous aponeurotomy
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytren Disease
Eligibility Criteria
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
Sites / Locations
- Diaconesses Croix Saint-Simon Hospital Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Percutaneous aponeurotomy
Arm Description
Treatment of Dupuytrens-induced finger flessum using percutaneous aponeurotomy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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°
Frequency of local relapse at 12 months
Frequency of local relapse at 36 months
Frequency of local relapse at 48 months
Frequency of local relapse at 60 months
Full Information
NCT ID
NCT02474576
First Posted
June 12, 2015
Last Updated
February 10, 2021
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
1. Study Identification
Unique Protocol Identification Number
NCT02474576
Brief Title
Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease
Acronym
APADUP
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous aponeurotomy
Arm Type
Experimental
Arm Description
Treatment of Dupuytrens-induced finger flessum using percutaneous aponeurotomy
Intervention Type
Procedure
Intervention Name(s)
Percutaneous aponeurotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of local relapse at 24 months
Description
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
Time Frame
24 months after treatment by aponeurotomy
Secondary Outcome Measure Information:
Title
Primary success rate of aponeurotomy
Description
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°
Time Frame
3 months after treatment
Title
Frequency of local relapse at 12 months
Time Frame
12 months after treatment by aponeurotomy
Title
Frequency of local relapse at 36 months
Time Frame
36 months after treatment by aponeurotomy
Title
Frequency of local relapse at 48 months
Time Frame
48 months after treatment by aponeurotomy
Title
Frequency of local relapse at 60 months
Time Frame
60 months after treatment by aponeurotomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Diaconesses Croix Saint-Simon Hospital Group
City
Paris
ZIP/Postal Code
75020
Country
France
12. IPD Sharing Statement
Learn more about this trial
Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease
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