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NCT Number: NCT02474576

Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease

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.

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Key information

Conditions

Dupuytren Disease Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diaconesses Croix Saint-Simon Hospital Group

Paris, 75020, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous aponeurotomy

Procedure

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 outcomes

  1. 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 outcomes

  1. 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°

  2. Frequency of local relapse at 12 months

    Time frame: 12 months after treatment by aponeurotomy

  3. Frequency of local relapse at 36 months

    Time frame: 36 months after treatment by aponeurotomy

  4. Frequency of local relapse at 48 months

    Time frame: 48 months after treatment by aponeurotomy

  5. Frequency of local relapse at 60 months

    Time frame: 60 months after treatment by aponeurotomy

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Acronym: APADUP

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Jun 17, 2015
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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