<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03797690</url>
  </required_header>
  <id_info>
    <org_study_id>P160903J</org_study_id>
    <nct_id>NCT03797690</nct_id>
  </id_info>
  <brief_title>Effectiveness of Percutaneous Needle Aponeurotomy</brief_title>
  <acronym>EFAPAD</acronym>
  <official_title>Effectiveness of Percutaneous Needle Aponeurotomy for Dupuytren's Disease: a Multicenter, Randomised, Non-inferiority Trial, With Surgery as Comparator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective is to investigate if percutaneous needle aponeurotomy is non-inferior to&#xD;
      open surgery using aponeurectomy in treatment of flexion contracture due to Dupuytren's&#xD;
      disease.&#xD;
&#xD;
      Our hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety&#xD;
      profile for large application in the treatment of Dupuytren's disease and that it is&#xD;
      consequently able to drastically reduce the need of open surgery in this indication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scientific justification:&#xD;
&#xD;
      Dupuytren's disease is a world-wide musculoskeletal disorder. It consists in fibrosis of the&#xD;
      palmar aponeurosis that can induce disabling flexion contracture of the metacarpophalageal or&#xD;
      proximal interphalangeal joints. Treatment modalities of flexion contracture include open&#xD;
      surgery, percutaneous needle aponeurotomy and collagenase. Collagenase is not available in&#xD;
      France. Aponeurectomy, that is also called fasciectomy, is the main open surgical technique,&#xD;
      and open surgery is the most frequently used treatment in Dupuytren's disease. Percutaneous&#xD;
      needle aponeurotomy is recommended as a nonsurgical treatment for Dupuytren's disease. It is&#xD;
      a minimally invasive procedure. Its most largely accepted indication is Dupuytren's disease&#xD;
      with metacarpophalageal joint involvement. However, percutaneous needle aponeurotomy has been&#xD;
      successful for metacarpophalageal or proximal interphalangeal joint involvement, in&#xD;
      nonadvanced and in advanced Dupuytren's disease. A model analysis recently demonstrated that&#xD;
      replacing open surgery with percutaneous needle aponeurotomy could save more than 50% of the&#xD;
      total hospitalization costs for the disease.&#xD;
&#xD;
      Percutaneous needle aponeurotomy therefore appears as a unique minimally invasive approach&#xD;
      for Dupuytren's disease. It could become a valuable alternative to open surgery. The&#xD;
      hypothesis is that percutaneous needle aponeurotomy has suitable efficacy and safety profile&#xD;
      for large application in the treatment of Dupuytren's disease and that it is consequently&#xD;
      able to drastically reduce the need of open surgery in this indication.&#xD;
&#xD;
      Practical procedure:&#xD;
&#xD;
      Patients addressed to the consultation of the hand surgery centers for Dupuytren's disease&#xD;
      will be prospectively selected, included, randomized, treated using percutaneous needle&#xD;
      aponeurotomy or open surgery within six weeks after randomization, and followed at 1 week, 1,&#xD;
      3,12, 24 and 36 months after treatment. Assessment of efficacy will be blinded. Assessment of&#xD;
      complications will be done by an unblinded assessor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Anticipated">December 14, 2028</completion_date>
  <primary_completion_date type="Anticipated">March 14, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The primary outcome (main metacarpophalangeal joint contracture during passive extension) will be assessed using low energy computed tomography before treatment, 3 months and 36 months after treatment for blinded assessment. Furthermore, in addition to the clinical follow-up, the patient will be followed by a blinded assessor. At each follow-up visits with the blinded assessor, patient will be asked to wear white opaque gloves to ensure the blinding for the treatment during assessment including the main outcome. Clinicians, nurses and patients will be instructed to the importance of avoiding communication about the treatment to the blinded assessor.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Metacarpophalangeal joint contracture during passive extension</measure>
    <time_frame>at 3 months after treatment</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metacarpophalangeal joint contractures during passive and active extension</measure>
    <time_frame>at 1 week, 1, 3, 12, 24 and 36 months after treatment</time_frame>
    <description>Expressed in degrees using clinical goniometry, and patient wearing white opac gloves to ensure blinded assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Main metacarpophalangeal joint contracture during passive extension,</measure>
    <time_frame>at 36 months after treament</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The clinical success</measure>
    <time_frame>at 3 months after treament</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The recurrence</measure>
    <time_frame>at 12, 24 and 36 months after treament</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The interphalangeal joint contractures during passive and active extension</measure>
    <time_frame>at 1 week, 1, 3,12, 24 and 36 months after treatment</time_frame>
    <description>Expressed in degrees, using clinical goniometry. Patient will wear white opac gloves to ensure blinded assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 70% improvement from baseline of the flexion contracture</measure>
    <time_frame>at 1 week, 1, 3, 12, 24 and 36 months after treatment</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The active range of motion of metacarpophalangeal and proximal interphalangeal treated joints</measure>
    <time_frame>at 1 week, 1, 3, 12, 24 and 36 months after treatment</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The functional limitation using Quick DASH questionnaire</measure>
    <time_frame>at 1 week, 1, 3, 12, 24 and 36 months after treatment</time_frame>
    <description>The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 100, with highest value indicating highest disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The URAM scale</measure>
    <time_frame>at 1 week, 1, 3, 12, 24 and 36 months after treatment</time_frame>
    <description>The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 45, with highest value indicating highest disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The patient satisfaction on a 0-100 mm visual analog scale</measure>
    <time_frame>at 1 week, 1, 3, 12, 24 and 36 months after treatment</time_frame>
    <description>The assessor will ask the patient the following question: &quot;How would you rate satisfaction about the treatment you underwent in the study?&quot; Patients will be asked to mark the level of their satisfaction on a l00-mm, nonhatched VAS scale marked at one end as &quot;not satisfied&quot; and at the other as &quot;completely satisfied''</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of secondary and repeated treatments</measure>
    <time_frame>at 12, 24 and 36 months after treatment</time_frame>
    <description>The number of secondary or repeated open surgeries and percutaneous needle aponeurotomy will be recorded by the unblinded assessor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications and adverse events for primary treatment</measure>
    <time_frame>at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications and adverse events for secondary treatment</measure>
    <time_frame>at the treatment time, at 12, 24 and 36 months;</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The post-interventional pain and needs</measure>
    <time_frame>at 1 week, 1, 3, 12, 24 and 36 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Dupuytren Disease of Finger</condition>
  <arm_group>
    <arm_group_label>Percutaneous needle aponeurotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open surgery with limited aponeurectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous needle aponeurotomy</intervention_name>
    <description>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</description>
    <arm_group_label>Percutaneous needle aponeurotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open surgery with limited aponeurectomy</intervention_name>
    <description>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)</description>
    <arm_group_label>Open surgery with limited aponeurectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Ascertained Dupuytren disease: palpable fibrotic nodule or cord developed from the&#xD;
             palmar aponeurosis, flexion contracture of a metacarpophalangeal or proximal&#xD;
             interphalangeal joint.&#xD;
&#xD;
          -  Presence of at least one flexion contracture of a metacarpophalangeal joint of the&#xD;
             hand due to Dupuytren's disease and &gt; or = 20°&#xD;
&#xD;
          -  Written informed consent signed by the patient&#xD;
&#xD;
          -  Patient affiliated to the social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of other musculoskeletal disorders of the hand than Dupuytren's disease:&#xD;
             known inflammatory rheumatic disease of the hand, clinical signs of inflammatory&#xD;
             rheumatic disease of the hand, MP or PIP pain at inclusion visit.&#xD;
&#xD;
          -  Previous open surgery of the hand for any reason&#xD;
&#xD;
          -  Any other pathological condition or limited range of motion in the finger to be&#xD;
             treated&#xD;
&#xD;
          -  Psychiatric status precluding patient evaluation; vulnerable persons; adults under&#xD;
             legal protection order or incompetent, physically or mentally incapable of giving his&#xD;
             consent.&#xD;
&#xD;
          -  Pregnant or beastfeeding women&#xD;
&#xD;
          -  Participation in another interventional trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johann BEAUDREUIL, PUPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Johann BEAUDREUIL, PUPH</last_name>
    <phone>+33 1 49 95 88 28</phone>
    <email>johann.beaudruil@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre d'Imagerie Médicale Bachaumont Paris Centre</name>
      <address>
        <city>Paris</city>
        <zip>75002</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital LARIBOISIERE - Radiologie</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital LARIBOISIERE - Rhumatologie</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johann BEAUDREUIL, PUPH</last_name>
      <phone>01 49 95 88 28</phone>
      <email>johann.beaudreuil@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>JOUVENET - Orthopédie, chirurgie de la main et du membre supérieur</name>
      <address>
        <city>Paris</city>
        <zip>75016</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ERIC ROULOT, PH</last_name>
      <phone>01 42 15 42 33</phone>
      <email>secretaire.roulot@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dupuytren's disease</keyword>
  <keyword>Percutaneous needle aponeurotomy</keyword>
  <keyword>Limited aponeurectomy</keyword>
  <keyword>Randomized trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dupuytren Contracture</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03797690
org study id: P160903J
nct id: NCT03797690
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: The primary outcome (main metacarpophalangeal joint contracture during passive extension) will be assessed using low energy computed tomography before treatment, 3 months and 36 months after treatment for blinded assessment. Furthermore, in addition to the clinical follow-up, the patient will be followed by a blinded assessor. At each follow-up visits with the blinded assessor, patient will be asked to wear white opaque gloves to ensure the blinding for the treatment during assessment including the main outcome. Clinicians, nurses and patients will be instructed to the importance of avoiding communication about the treatment to the blinded assessor.
measure: Metacarpophalangeal joint contracture during passive extension
time frame: at 3 months after treatment
description: 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
measure: Metacarpophalangeal joint contractures during passive and active extension
time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
description: Expressed in degrees using clinical goniometry, and patient wearing white opac gloves to ensure blinded assessment.
measure: Main metacarpophalangeal joint contracture during passive extension,
time frame: at 36 months after treament
description: 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).
measure: The clinical success
time frame: at 3 months after treament
description: 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.
measure: The recurrence
time frame: at 12, 24 and 36 months after treament
description: 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.
measure: The interphalangeal joint contractures during passive and active extension
time frame: at 1 week, 1, 3,12, 24 and 36 months after treatment
description: Expressed in degrees, using clinical goniometry. Patient will wear white opac gloves to ensure blinded assessment.
measure: The 70% improvement from baseline of the flexion contracture
time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
description: 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
measure: 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
description: 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).
measure: The functional limitation using Quick DASH questionnaire
time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
description: The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 100, with highest value indicating highest disability).
measure: The URAM scale
time frame: at 1 week, 1, 3, 12, 24 and 36 months after treatment
description: The patient will fill out the auto-questionnaire. The blinded assessor will calculate the score (0 to 45, with highest value indicating highest disability).
measure: 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
description: 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''
measure: The number of secondary and repeated treatments
time frame: at 12, 24 and 36 months after treatment
description: The number of secondary or repeated open surgeries and percutaneous needle aponeurotomy will be recorded by the unblinded assessor.
measure: Complications and adverse events for primary treatment
time frame: at the treatment time, and at 1 week, 1, 3, 12, 24 and 36 months;
description: 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.
measure: Complications and adverse events for secondary treatment
time frame: at the treatment time, at 12, 24 and 36 months;
description: 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.
measure: The post-interventional pain and needs
time frame: at 1 week, 1, 3, 12, 24 and 36 months
description: 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.
arm group label: Percutaneous needle aponeurotomy
arm group type: Experimental
description: 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.
arm group label: Open surgery with limited aponeurectomy
arm group type: Active Comparator
description: 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).
intervention type: Procedure
intervention name: Percutaneous needle aponeurotomy
description: 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
arm group label: Percutaneous needle aponeurotomy
intervention type: Procedure
intervention name: Open surgery with limited aponeurectomy
description: 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)
arm group label: Open surgery with limited aponeurectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johann BEAUDREUIL, PUPH
role: Principal Investigator
affiliation: APHP
last name: Johann BEAUDREUIL, PUPH
phone: +33 1 49 95 88 28
email: johann.beaudruil@aphp.fr
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Dupuytren Contracture