Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease (APADUP)
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|ClinicalTrials.gov Identifier: NCT02474576|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2015
Last Update Posted : February 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Dupuytren Disease||Procedure: Percutaneous aponeurotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2020|
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.
- 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
- 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°
- Frequency of local relapse at 12 months [ Time Frame: 12 months after treatment by aponeurotomy ]
- Frequency of local relapse at 36 months [ Time Frame: 36 months after treatment by aponeurotomy ]
- Frequency of local relapse at 48 months [ Time Frame: 48 months after treatment by aponeurotomy ]
- Frequency of local relapse at 60 months [ Time Frame: 60 months after treatment by aponeurotomy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474576
|Diaconesses Croix Saint-Simon Hospital Group|
|Paris, France, 75020|