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

NCT04164953 | Unknown

• 1 other identifier: 2017-A03363-50
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dupuytren's Disease; Surgical Incision

Outcome Measures

Primary Outcomes (1)

• joint deformity

  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

Study Arms (1)

Dupuytren's

EXPERIMENTAL

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

Procedure: Surgical treatment

Interventions

Surgical treatment PROCEDURE

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

Dupuytren's

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• Dr ROULOT: collaborator

Study Sites (1)

Clinic Jouvenet

Paris, IDF, 75016, France

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture; Surgical Wound

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Wounds and Injuries

Central Study Contacts

JEANFRANCOIS OUDET

CONTACT

+33683346567; jeanfrancois.oudet@free.fr

MH barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: April 12, 2019
• Primary Completion: June 5, 2020
• Study Completion: June 30, 2021
• Last Updated: November 19, 2019

Record last verified: 2019-09

Locations

FR (1)