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

NCT ID: NCT04164953

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-12
• Study Completion Date: 2021-06-30

Brief Summary

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.

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.

Conditions

Dupuytren's Disease; Surgical Incision

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dupuytren's

Surgical intervention as second-line surgery for the treatment of Dupuytren's disease.

Group Type: EXPERIMENTAL

Surgical treatment

Intervention Type: PROCEDURE

Surgical treatment of Dupuytren's disease. Average from 2 to 4 joints per hand operated on simultaneously

Interventions

Surgical treatment

Surgical treatment of Dupuytren's disease. Average from 2 to 4 joints per hand operated on simultaneously

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr ROULOT

UNKNOWN

Sponsor Role: collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinic Jouvenet

Paris, IDF, France

Site Status: RECRUITING

Countries

France

Central Contacts

JEANFRANCOIS OUDET

Role: CONTACT

jeanfrancois.oudet@free.fr

+33683346567 ext. +33683346567

MH barba

Role: CONTACT

mh.barba@ecten.eu

Facility Contacts

JEANFRANCOIS OUDET

Role: primary

jeanfrancois.oudet@free.fr

+33683346567 ext. +33683346567

Marie Barba

Role: backup

mh.barba@ecten.eu

+330664888704 ext. +330664888704

Other Identifiers

2017-A03363-50

Identifier Type: -

Identifier Source: org_study_id