Dupuytren DiseaseAPADUPNCT02474576
Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease
A study testing Percutaneous aponeurotomy in people with Dupuytren Disease, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Disease
- What is being tested?
- Percutaneous aponeurotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Apr 2020
- 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 suffers from Dupuytren disease
- Patient has at least one finger with at least 20° flessum on the metacarpophalangeal joint and/or on the proximal interphalangeal joint
- Patient has chosen to benefit from local treatment
Who cannot join
- Pregnancy
- Breastfeeding
- No social insurance
Trial locations and contacts
1 site in 1 country.
About this study
The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known.
This study aims primarily at measuring the incidence rate of local relapse of Dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in Dupuytrens.
- Conditions
- Dupuytren Disease
- Being tested
- Percutaneous aponeurotomy
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous aponeurotomyProcedure or surgery
The finger(s) with limited extension due to Dupuytrens disease and for which the patient desires treatment, will be treated by fine-needle percutaneous aponeurotomy under local anesthesia (outpatient procedure). This procedure is already routinely used in clinical practice ; our study aims at better describing the time-sustainability of its benefits.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous aponeurotomy | Experimental | Treatment of Dupuytrens-induced finger flessum using percutaneous aponeurotomy Receives: Procedure: Percutaneous aponeurotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of local relapse at 24 months
the statistical unit is the finger treated by aponeurotomy (we expect an average of 2 fingers treated for one patient included). Local relapse is defined as the recurrence of a finger flessum superior by 20° to the articular range initially obtained after aponeurotomy
Measured: 24 months after treatment by aponeurotomy
Secondary outcomes (5)
Primary success rate of aponeurotomy
the statistical unit is the finger treated by aponeurotomy (we expect an average of 2 fingers treated for one patient included). Complete success is defined as a finger flessum inferior to 5°
Measured: 3 months after treatment
Frequency of local relapse at 12 months
Measured: 12 months after treatment by aponeurotomy
Frequency of local relapse at 36 months
Measured: 36 months after treatment by aponeurotomy
Frequency of local relapse at 48 months
Measured: 48 months after treatment by aponeurotomy
Frequency of local relapse at 60 months
Measured: 60 months after treatment by aponeurotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2019
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474576
- Sponsor's protocol ID
- MMN_2015-1
- Acronym
- APADUP
- Status last verified
- Feb 2021
- First submitted
- 12 Jun 2015
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease
- ClinicalTrials.gov ID
- NCT02474576
- Acronym / sponsor ID
- APADUP / MMN_2015-1
- Conditions
- Dupuytren Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 17 Jun 2015 (estimated)
- 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.
The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known.
This study aims primarily at measuring the incidence rate of local relapse of Dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in Dupuytrens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous aponeurotomy | Experimental | Procedure: Percutaneous aponeurotomyTreatment of Dupuytrens-induced finger flessum using percutaneous aponeurotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient suffers from Dupuytren disease
- Patient has at least one finger with at least 20° flessum on the metacarpophalangeal joint and/or on the proximal interphalangeal joint
- Patient has chosen to benefit from local treatment
Key exclusion criteria (3 listed)
- Pregnancy
- Breastfeeding
- No social insurance
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 |
|---|---|---|
| Percutaneous aponeurotomyThe finger(s) with limited extension due to Dupuytrens disease and for which the patient desires treatment, will be treated by fine-needle percutaneous aponeurotomy under local anesthesia (outpatient procedure). This procedure is already routinely used in clinical practice ; our study aims at better describing the time-sustainability of its benefits. | Procedure or surgery | Percutaneous aponeurotomy |
Primary outcome
Frequency of local relapse at 24 months
Time frame: 24 months after treatment by aponeurotomy
the statistical unit is the finger treated by aponeurotomy (we expect an average of 2 fingers treated for one patient included). Local relapse is defined as the recurrence of a finger flessum superior by 20° to the articular range initially obtained after aponeurotomy
5 secondary outcomes
Primary success rate of aponeurotomy
Time frame: 3 months after treatment
Frequency of local relapse at 12 months
Time frame: 12 months after treatment by aponeurotomy
Frequency of local relapse at 36 months
Time frame: 36 months after treatment by aponeurotomy
Frequency of local relapse at 48 months
Time frame: 48 months after treatment by aponeurotomy
Frequency of local relapse at 60 months
Time frame: 60 months after treatment by aponeurotomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous aponeurotomy in people with Dupuytren Disease, run by Groupe Hospitalier Diaconesses Croix Saint-Simon 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 11 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of local relapse at 24 months (time frame: 24 months after treatment by aponeurotomy). 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 11 Feb 2021.