Dupuytren Disease of FingerEFAPADNCT03797690
Effectiveness of Percutaneous Needle Aponeurotomy
A study testing Percutaneous needle aponeurotomy and Open surgery with limited aponeurectomy in people with Dupuytren Disease of Finger, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Disease of Finger
- What is being tested?
- Percutaneous needle aponeurotomy and Open surgery with limited aponeurectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Nov 2020to 14 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years old
- Ascertained Dupuytren disease: palpable fibrotic nodule or cord developed from the palmar aponeurosis, flexion contracture of a metacarpophalangeal or proximal interphalangeal joint.
- Presence of at least one flexion contracture of a metacarpophalangeal joint of the hand due to Dupuytren's disease and > or = 20°
- Written informed consent signed by the patient
- Patient affiliated to the social security
Who cannot join
- Presence of other musculoskeletal disorders of the hand than Dupuytren's disease: known inflammatory rheumatic disease of the hand, clinical signs of inflammatory rheumatic disease of the hand, MP or PIP pain at inclusion visit.
- Previous surgery of the hand to be treated resulting in functional limitation or limitation of finger mobility
- Any other pathological condition or limited range of motion in the finger to be treated
- Psychiatric status precluding patient evaluation; vulnerable persons; adults under legal protection order or incompetent, physically or mentally incapable of giving his consent.
- Pregnant or beastfeeding women
- Participation in another interventional trial
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 2 recruiting
- Active, not recruiting
Centre d'Imagerie Médicale Bachaumont Paris Centre
Paris, 75002
- Active, not recruiting
Hopital LARIBOISIERE - Radiologie
Paris, 75010
- Recruiting
Hopital LARIBOISIERE - Rhumatologie
Paris, 75010
Johann BEAUDREUIL, PUPH, 01 49 95 88 28, johann.beaudreuil@aphp.fr
- Recruiting
JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur
Paris, 75016
ERIC ROULOT, PH, 01 42 15 42 33, secretaire.roulot@gmail.com
About this study
Official title: Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's disease.
Our hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
Read the detailed description
Scientific justification:
Dupuytren's disease is a world-wide musculoskeletal disorder. It consists in fibrosis of the palmar aponeurosis that can induce disabling flexion contracture of the metacarpophalageal or proximal interphalangeal joints. Treatment modalities of flexion contracture include open surgery, percutaneous needle aponeurotomy and collagenase. Collagenase is not available in France. Aponeurectomy, that is also called fasciectomy, is the main open surgical technique, and open surgery is the most frequently used treatment in Dupuytren's disease. Percutaneous needle aponeurotomy is recommended as a nonsurgical treatment for Dupuytren's disease. It is a minimally invasive procedure. Its most largely accepted indication is Dupuytren's disease with metacarpophalageal joint involvement. However, percutaneous needle aponeurotomy has been successful for metacarpophalageal or proximal interphalangeal joint involvement, in nonadvanced and in advanced Dupuytren's disease. A model analysis recently demonstrated that replacing open surgery with percutaneous needle aponeurotomy could save more than 50% of the total hospitalization costs for the disease.
Percutaneous needle aponeurotomy therefore appears as a unique minimally invasive approach for Dupuytren's disease. It could become a valuable alternative to open surgery. The hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
Practical procedure:
Patients addressed to the consultation of the hand surgery centers for Dupuytren's disease will be prospectively selected, included, randomized, treated using percutaneous needle aponeurotomy or open surgery within six weeks after randomization, and followed at 1 week, 1, 3,12, 24 and 36 months after treatment. Assessment of efficacy will be blinded. Assessment of complications will be done by an unblinded assessor.
- Conditions
- Dupuytren Disease of Finger
- Being tested
- Percutaneous needle aponeurotomy, Open surgery with limited aponeurectomy
- Keywords
- Dupuytren's disease, Percutaneous needle aponeurotomy, Limited aponeurectomy, Randomized trial
- 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 needle aponeurotomyProcedure or surgery
It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure
Open surgery with limited aponeurectomyProcedure or surgery
It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy)
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous needle aponeurotomy | Experimental | It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure. End of treatment will be considered as the last session of needle aponeurotomy. Receives: Procedure: Percutaneous needle aponeurotomy |
| Open surgery with limited aponeurectomy | Active comparator | It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy). End of surgical treatment will be considered as the removal of the stitches (two weeks after the surgical treatment). Receives: Procedure: Open surgery with limited aponeurectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metacarpophalangeal joint contracture during passive extension
Expressed in degrees, using low energy computed tomography for blinded assessment (computed tomography imaging will be analysed by a blinded assessor not involved in the treatment). Baseline will be Metacarpophalangeal joint contracture during passive extension the day of the treatment, before any treatment
Measured: at 3 months after treatment
Secondary outcomes (14)
Metacarpophalangeal joint contractures during passive and active extension
Expressed in degrees using clinical goniometry, and patient wearing white opac gloves to ensure blinded assessment.
Measured: at 1 week, 1, 3, 12, 24 and 36 months after treatment
Main metacarpophalangeal joint contracture during passive extension,
Expressed in degrees, using low energy computed tomography, for blinded assessment (computed tomography imaging will be analysed by a blinded assessor not involved in the treatment).
Measured: at 36 months after treament
The clinical success
The clinical success is defined as the reduction of flexum to within 0 to 5° during passive extension, using clinical goniometry, for the main metacarpophalangeal joint); Patient will wear white opac gloves to ensure blinded assessment.
Measured: at 3 months after treament
The recurrence
The recurrence is defined as the flexum progression of 20°, during passive extension, using clinical goniometry, after clinical success. Patient will wear white opac gloves to ensure blinded assessment.
Measured: at 12, 24 and 36 months after treament
The interphalangeal joint contractures during passive and active extension
Expressed in degrees, using clinical goniometry. Patient will wear white opac gloves to ensure blinded assessment.
Measured: at 1 week, 1, 3,12, 24 and 36 months after treatment
The 70% improvement from baseline of the flexion contracture
The flexion contracture of each treated joint, during passive extension will be assessed by a blinded assessor (Patient will wear white opac gloves). - Flexion contracture in degrees using goniometry reported as follows: ray Number; metacarpophalangeal angle; interphalangeal angle
Measured: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints
The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints will be assessed by a blinded assessor (Patient will wear white opac gloves).
Measured: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The functional limitation using Quick DASH questionnaire
The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 100, with highest value indicating highest disability).
Measured: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The URAM scale
The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 45, with highest value indicating highest disability).
Measured: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The patient satisfaction on a 0-100 mm visual analog scale
The assessor will ask the patient the following question: "How would you rate satisfaction about the treatment you underwent in the study?" Patients will be asked to mark the level of their satisfaction on a l00-mm, nonhatched VAS scale marked at one end as "not satisfied" and at the other as "completely satisfied''
Measured: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The number of secondary and repeated treatments
The number of secondary or repeated open surgeries and percutaneous needle aponeurotomy will be recorded by the unblinded assessor.
Measured: at 12, 24 and 36 months after treatment
Complications and adverse events for primary treatment
The number and the types of complications and adverse events for primary open surgery and first line percutaneous needle aponeurotomy will be collected by an unblinded assessor.
Measured: at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;
Complications and adverse events for secondary treatment
The number and the types of complications and adverse events for secondary open surgery and percutaneous needle aponeurotomy will be collected by an unblinded assessor.
Measured: at the treatment time, at 12, 24 and 36 months;
The post-interventional pain and needs
The post-interventional pain and needs of nursing, splinting, medication, physiotherapy,sick leave, time return to regular activities using a patient diary. These datas will be collected by the unblinded assessor.
Measured: at 1 week, 1, 3, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start2 Nov 2020
- Primary completion14 Mar 2027 (estimated)
- Study completion14 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren Disease of FingerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, non-inferiority PROBE (Prospective Randomized Open Blinded End-point) trial. Two groups (ratio 1:1) will be compared in this phase III pivotal study: experimental group versus control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johann BEAUDREUIL, PUPH, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797690
- Sponsor's protocol ID
- P160903J
- Acronym
- EFAPAD
- Status last verified
- Apr 2025
- First submitted
- 25 Jun 2018
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator
- ClinicalTrials.gov ID
- NCT03797690
- Acronym / sponsor ID
- EFAPAD / P160903J
- Conditions
- Dupuytren Disease of Finger
- Keywords
- Dupuytren's disease, Percutaneous needle aponeurotomy, Limited aponeurectomy, Randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- 14 Feb 2029 (estimated)
- First posted
- 9 Jan 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.
The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's disease.
Our hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
Detailed description
Scientific justification:
Dupuytren's disease is a world-wide musculoskeletal disorder. It consists in fibrosis of the palmar aponeurosis that can induce disabling flexion contracture of the metacarpophalageal or proximal interphalangeal joints. Treatment modalities of flexion contracture include open surgery, percutaneous needle aponeurotomy and collagenase. Collagenase is not available in France. Aponeurectomy, that is also called fasciectomy, is the main open surgical technique, and open surgery is the most frequently used treatment in Dupuytren's disease. Percutaneous needle aponeurotomy is recommended as a nonsurgical treatment for Dupuytren's disease. It is a minimally invasive procedure. Its most largely accepted indication is Dupuytren's disease with metacarpophalageal joint involvement. However, percutaneous needle aponeurotomy has been successful for metacarpophalageal or proximal interphalangeal joint involvement, in nonadvanced and in advanced Dupuytren's disease. A model analysis recently demonstrated that replacing open surgery with percutaneous needle aponeurotomy could save more than 50% of the total hospitalization costs for the disease.
Percutaneous needle aponeurotomy therefore appears as a unique minimally invasive approach for Dupuytren's disease. It could become a valuable alternative to open surgery. The hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile for large application in the treatment of Dupuytren's disease and that it is consequently able to drastically reduce the need of open surgery in this indication.
Practical procedure:
Patients addressed to the consultation of the hand surgery centers for Dupuytren's disease will be prospectively selected, included, randomized, treated using percutaneous needle aponeurotomy or open surgery within six weeks after randomization, and followed at 1 week, 1, 3,12, 24 and 36 months after treatment. Assessment of efficacy will be blinded. Assessment of complications will be done by an unblinded assessor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, non-inferiority PROBE (Prospective Randomized Open Blinded End-point) trial. Two groups (ratio 1:1) will be compared in this phase III pivotal study: experimental group versus control group.
| Arm | Type | Receives |
|---|---|---|
| Percutaneous needle aponeurotomy | Experimental | Procedure: Percutaneous needle aponeurotomyIt consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure. End of treatment will be considered as the last session of needle aponeurotomy. |
| Open surgery with limited aponeurectomy | Active comparator | Procedure: Open surgery with limited aponeurectomyIt consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy). End of surgical treatment will be considered as the removal of the stitches (two weeks after the surgical treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Ascertained Dupuytren disease: palpable fibrotic nodule or cord developed from the palmar aponeurosis, flexion contracture of a metacarpophalangeal or proximal interphalangeal joint.
- Presence of at least one flexion contracture of a metacarpophalangeal joint of the hand due to Dupuytren's disease and > or = 20°
- Written informed consent signed by the patient
- Patient affiliated to the social security
Key exclusion criteria (6 listed)
- Presence of other musculoskeletal disorders of the hand than Dupuytren's disease: known inflammatory rheumatic disease of the hand, clinical signs of inflammatory rheumatic disease of the hand, MP or PIP pain at inclusion visit.
- Previous surgery of the hand to be treated resulting in functional limitation or limitation of finger mobility
- Any other pathological condition or limited range of motion in the finger to be treated
- Psychiatric status precluding patient evaluation; vulnerable persons; adults under legal protection order or incompetent, physically or mentally incapable of giving his consent.
- Pregnant or beastfeeding women
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 needle aponeurotomyIt consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure | Procedure or surgery | Percutaneous needle aponeurotomy |
| Open surgery with limited aponeurectomyIt consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy) | Procedure or surgery | Open surgery with limited aponeurectomy |
Primary outcome
Metacarpophalangeal joint contracture during passive extension
Time frame: at 3 months after treatment
Expressed in degrees, using low energy computed tomography for blinded assessment (computed tomography imaging will be analysed by a blinded assessor not involved in the treatment). Baseline will be Metacarpophalangeal joint contracture during passive extension the day of the treatment, before any treatment
14 secondary outcomes
Metacarpophalangeal joint contractures during passive and active extension
Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
Main metacarpophalangeal joint contracture during passive extension,
Time frame: at 36 months after treament
The clinical success
Time frame: at 3 months after treament
The recurrence
Time frame: at 12, 24 and 36 months after treament
The interphalangeal joint contractures during passive and active extension
Time frame: at 1 week, 1, 3,12, 24 and 36 months after treatment
The 70% improvement from baseline of the flexion contracture
Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints
Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The functional limitation using Quick DASH questionnaire
Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The URAM scale
Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The patient satisfaction on a 0-100 mm visual analog scale
Time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
The number of secondary and repeated treatments
Time frame: at 12, 24 and 36 months after treatment
Complications and adverse events for primary treatment
Time frame: at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;
Complications and adverse events for secondary treatment
Time frame: at the treatment time, at 12, 24 and 36 months;
The post-interventional pain and needs
Time frame: at 1 week, 1, 3, 12, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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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.
Johann BEAUDREUIL, PUPH principal investigator
APHP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous needle aponeurotomy and Open surgery with limited aponeurectomy in people with Dupuytren Disease of Finger, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johann BEAUDREUIL, PUPH (+33 1 49 95 88 28, johann.beaudruil@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metacarpophalangeal joint contracture during passive extension (time frame: at 3 months after treatment). 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 2 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.