Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease
APADUP
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedFebruary 11, 2021
February 1, 2021
3.6 years
June 12, 2015
February 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Primary success rate of aponeurotomy
3 months after treatment
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
Frequency of local relapse at 48 months
48 months after treatment by aponeurotomy
Frequency of local relapse at 60 months
60 months after treatment by aponeurotomy
Study Arms (1)
Percutaneous aponeurotomy
EXPERIMENTALTreatment of Dupuytrens-induced finger flessum using percutaneous aponeurotomy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Breastfeeding
- No social insurance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diaconesses Croix Saint-Simon Hospital Group
Paris, 75020, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 17, 2015
Study Start
September 1, 2015
Primary Completion
April 1, 2019
Study Completion
April 1, 2020
Last Updated
February 11, 2021
Record last verified: 2021-02