Dupuytren's DiseaseURAM3NCT04164953
Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease.
A study testing Surgical treatment in people with Dupuytren's Disease and Surgical Incision, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease, Surgical Incision
- What is being tested?
- Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
MH barba contact
France1 site, 1 recruiting
- Recruiting
Clinic Jouvenet
Paris, IDF, 75016
JEANFRANCOIS OUDET, +33683346567 ext. +33683346567, jeanfrancois.oudet@free.fr
Marie Barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
About this study
Official title: 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.
Read the 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
- Being tested
- Surgical treatment
- Medical subject headings
- Dupuytren Contracture, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatmentProcedure or surgery
Surgical treatment of Dupuytren's disease. Average from 2 to 4 joints per hand operated on simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Dupuytren's | Experimental | Surgical intervention as second-line surgery for the treatment of Dupuytren's disease. Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start12 Apr 2019
- Primary completion5 Jun 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's DiseaseStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Surgical intervention as second-line surgery for the treatment of Dupuytren's disease.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr ROULOT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164953
- Sponsor's protocol ID
- 2017-A03363-50
- Acronym
- URAM3
- Status last verified
- Sep 2019
- First submitted
- 13 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease. URAM 3
- ClinicalTrials.gov ID
- NCT04164953
- Acronym / sponsor ID
- URAM3 / 2017-A03363-50
- Conditions
- Dupuytren's Disease, Surgical Incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr ROULOT
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 5 Jun 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Surgical intervention as second-line surgery for the treatment of Dupuytren's disease.
| Arm | Type | Receives |
|---|---|---|
| Dupuytren's | Experimental | Procedure: Surgical treatmentSurgical intervention as second-line surgery for the treatment of Dupuytren's disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatmentSurgical treatment of Dupuytren's disease. Average from 2 to 4 joints per hand operated on simultaneously | Procedure or surgery | Dupuytren's |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MH barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment in people with Dupuytren's Disease and Surgical Incision, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JEANFRANCOIS OUDET (+33683346567 ext. +33683346567, jeanfrancois.oudet@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
joint deformity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.