Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease. (URAM3)
Primary Purpose
Dupuytren's Disease, Surgical Incision
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Dupuytren's Disease
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.
Sites / Locations
- Clinic JouvenetRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dupuytren's
Arm Description
Surgical intervention as second-line surgery for the treatment of Dupuytren's disease.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04164953
First Posted
November 13, 2019
Last Updated
November 15, 2019
Sponsor
Ramsay Générale de Santé
Collaborators
Dr ROULOT
1. Study Identification
Unique Protocol Identification Number
NCT04164953
Brief Title
Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease.
Acronym
URAM3
Official Title
Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease. URAM 3
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
June 5, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Dr ROULOT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dupuytren's Disease, Surgical Incision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Surgical intervention as second-line surgery for the treatment of Dupuytren's disease.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dupuytren's
Arm Type
Experimental
Arm Description
Surgical intervention as second-line surgery for the treatment of Dupuytren's disease.
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Intervention Description
Surgical treatment of Dupuytren's disease. Average from 2 to 4 joints per hand operated on simultaneously
Primary Outcome Measure Information:
Title
joint deformity
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JEANFRANCOIS OUDET
Phone
+33683346567
Ext
+33683346567
Email
jeanfrancois.oudet@free.fr
First Name & Middle Initial & Last Name or Official Title & Degree
MH barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Clinic Jouvenet
City
Paris
State/Province
IDF
ZIP/Postal Code
75016
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEANFRANCOIS OUDET
Phone
+33683346567
Ext
+33683346567
Email
jeanfrancois.oudet@free.fr
First Name & Middle Initial & Last Name & Degree
Marie Barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease.
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