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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02474576
First Posted: June 17, 2015
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Groupe Hospitalier Diaconesses Croix Saint-Simon
  Purpose

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 Intervention
Dupuytren Disease Procedure: Percutaneous aponeurotomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Diaconesses Croix Saint-Simon:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 130
Actual Study Start Date: September 2015
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Diaconesses Croix Saint-Simon Hospital Group
Paris, France, 75020
Sponsors and Collaborators
Groupe Hospitalier Diaconesses Croix Saint-Simon
  More Information

Responsible Party: Groupe Hospitalier Diaconesses Croix Saint-Simon
ClinicalTrials.gov Identifier: NCT02474576     History of Changes
Other Study ID Numbers: MMN_2015-1
First Submitted: June 12, 2015
First Posted: June 17, 2015
Last Update Posted: October 12, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Dupuytren Contracture
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Contracture
Muscular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases