Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease. (URAM3)

November 15, 2019 updated by: Ramsay Générale de Santé

Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease. URAM 3

As part of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease appears as a second-line treatment indicated in a situation of failure after treatment with percutaneous needle aponeurotomy.The results of second-line surgery in terms of safety and efficacy have not been specifically evaluated in patients who underwent failed percutaneous needle aponeurotomy. This evaluation nevertheless appears necessary for the validation of a medical-surgical strategy during Dupuytren's disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Dupuytren's disease is characterised by retractile fibrosis of the superficial palmar aponeurosis that can result in irreversible flexing of the fingers and long-term disability. The treatment of Dupuytren's disease, whether medical or surgical, remains symptomatic. It is based in Europe on percutaneous needle aponeurotomy and surgical aponeurectomy. Its objectives are the reduction of the deformity of the fingers in flexum, and that of the incapacity that generates the illness. Percutaneous needle aponeurotomy for Dupuytren's disease was developed by Jean-Luc Lermusiaux in 1972 in the Rheumatology Department of the Lariboisière Hospital in Paris. Its efficiency, its tolerance, its simplicity, its low cost and the possibility of repeating it make it a benchmark treatment. Percutaneous needle aponeurotomy is, for many, if the existence of this technique is known and understood, the first-line treatment of Dupuytren's disease.

As part of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease appears as a second-line treatment indicated in a situation of failure after treatment with percutaneous needle aponeurotomy. The safety and efficacy of the surgery was evaluated in the context of a first-line treatment of Dupuytren's disease. The results of second-line surgery in terms of safety and efficacy have not been specifically evaluated in patients who underwent failed percutaneous needle aponeurotomy. This evaluation nevertheless appears necessary for the validation of a medical-surgical strategy during Dupuytren's disease.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75016
        • Recruiting
        • Clinic Jouvenet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with Dupuytren's disease previously treated by percutaneous needle aponeurotomy and not satisfied after a delay of at least one month in regards to at least one of the treated segments (are you satisfied? response no)
  • Keeping a flexum > 20°
  • At least 18 years old
  • Informed about the study and having given their informed and written consent for participation
  • Registered with a social security scheme or the CMU (beneficiary or entitled)
  • having had a medical examination confirming the surgical indication (the results of which were communicated to them).

Exclusion Criteria:

  • Cognitive disorders deemed incompatible with participation in the trial by the researcher (inability to understand the information, give informed consent or follow the required assessments)
  • Pregnancy in progress confirmed by interview
  • language barrier that would prevent the achievement of a reliable evaluation
  • Superficial or deep palmo-digital infection or inflammation
  • Ruptured tendon of the flexor digitorum
  • Contraindication to surgery or anaesthesia
  • Participation of the patient in another clinical study in progress.

  • Protected adults under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision, Pregnant, lactating or parturient women, Hospitalised without consent.

    9- Patient who has already undergone the surgical procedure under study on one of the two hands in the last 12 months or patient requiring surgery for the second hand in the next 14 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dupuytren's
Surgical intervention as second-line surgery for the treatment of Dupuytren's disease.
Procedure: Surgical treatment
Surgical treatment of Dupuytren's disease. Average from 2 to 4 joints per hand operated on simultaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
joint deformity
Time Frame: 3 months
Primary end point: joint deformity of each treated joint at 3 months.• The development of the degree of joint extension malalignment at 3 months will be described both by the relative difference and by the absolute difference between the measurements at V0 and V3, overall and for each modality of the known prognostic factors: joint types (MCP versus PIP), age at onset of disease (<50 years versus >= 50 years), initial severity of disease.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

Dr ROULOT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2019

Primary Completion (Anticipated)

June 5, 2020

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A03363-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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