APADUP: Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease

• Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02474576
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arm: 1
• Actual Duration (Months): 55
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dupuytren Disease	Procedure: Percutaneous aponeurotomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Frequency of local relapse at 24 months [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

1. Primary success rate of aponeurotomy [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°

2. Frequency of local relapse at 12 months [12 months after treatment by aponeurotomy]

3. Frequency of local relapse at 36 months [36 months after treatment by aponeurotomy]

4. Frequency of local relapse at 48 months [48 months after treatment by aponeurotomy]

5. Frequency of local relapse at 60 months [60 months after treatment by aponeurotomy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Diaconesses Croix Saint-Simon Hospital Group	Paris		France	75020

Sponsors and Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Groupe Hospitalier Diaconesses Croix Saint-Simon
• ClinicalTrials.gov Identifier: NCT02474576
• Other Study ID Numbers: MMN_2015-1
• First Posted: Jun 17, 2015
• Last Update Posted: Feb 11, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Dupuytren Contracture

Study Results

No Results Posted as of Feb 11, 2021