<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/NCT03031080</url>
  </required_header>
  <id_info>
    <org_study_id>5396</org_study_id>
    <nct_id>NCT03031080</nct_id>
  </id_info>
  <brief_title>BOND Study: the Benefit Of Night Splinting in Dupuytrens'</brief_title>
  <acronym>BOND</acronym>
  <official_title>The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Liverpool University Hospitals NHS Foundation Trust</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 BOND study is a prospective, randomised single blinded controlled trial to assess the&#xD;
      effect of night splinting in patients who have had collagenase injection and manipulation&#xD;
      therapy for Dupuytren's Contracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on&#xD;
      functional and quality of life outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Intervention (Xiapex) was removed from the market&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Randomised Controlled Trial - Block Randomisation</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Initial heath-care provider and participant are not masked as would be impossible to do so. Outcome assessor (a different health care provider) and investigators will be masked as to whether the patient is in the splinted or unsplinted cohort.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>At 0 weeks, 12 weeks and 52 weeks</time_frame>
    <description>To assess change in range of motion measured in degrees between pre-treatment, immediately post-treatment, 12 weeks post-treatment and 12 months post-treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PEM Questionnaire</measure>
    <time_frame>At 0 weeks, 12 weeks and 52 weeks</time_frame>
    <description>Patient Evaluation Measure to give disability score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>URAM Questionnaire</measure>
    <time_frame>At 0 weeks, 12 weeks and 52 weeks</time_frame>
    <description>Hand specific outcome questionnaire to assess quality of life outcomes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dupuytren Contracture</condition>
  <arm_group>
    <arm_group_label>Splinted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Un-Splinted</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will not wear a night splint</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermoplastic Hand Splint</intervention_name>
    <description>Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.</description>
    <arm_group_label>Splinted</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Single digit contractures greater than 30 degrees&#xD;
&#xD;
          2. No prior surgery for their contractures.&#xD;
&#xD;
          3. Successful collagenase and manipulation therapy (contracture reduced to within 10&#xD;
             degrees of full extension).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Multiple digit contractures&#xD;
&#xD;
          2. Prior surgery for their contractures.&#xD;
&#xD;
          3. Failure of collagenase and manipulation therapy (contracture not reduced to within 10&#xD;
             degrees of full extension).&#xD;
&#xD;
          4. Inability to consent to treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graham Cheung, MBBCh FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Hand Surgeon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Liverpool &amp; Broadgreen University Hospitals NHS Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Collagenase, Night-splinting, Dupuytrens, Contracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dupuytren Contracture</mesh_term>
    <mesh_term>Contracture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03031080
org study id: 5396
nct id: NCT03031080
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The BOND study is a prospective, randomised single blinded controlled trial to assess the
      effect of night splinting in patients who have had collagenase injection and manipulation
      therapy for Dupuytren's Contracture.
This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on
      functional and quality of life outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised Controlled Trial - Block Randomisation
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: Initial heath-care provider and participant are not masked as would be impossible to do so. Outcome assessor (a different health care provider) and investigators will be masked as to whether the patient is in the splinted or unsplinted cohort.
measure: Range of motion
time frame: At 0 weeks, 12 weeks and 52 weeks
description: To assess change in range of motion measured in degrees between pre-treatment, immediately post-treatment, 12 weeks post-treatment and 12 months post-treatment
measure: PEM Questionnaire
time frame: At 0 weeks, 12 weeks and 52 weeks
description: Patient Evaluation Measure to give disability score
measure: URAM Questionnaire
time frame: At 0 weeks, 12 weeks and 52 weeks
description: Hand specific outcome questionnaire to assess quality of life outcomes
arm group label: Splinted
arm group type: Active Comparator
description: Patients will be given Thermoplastic Hand Splint to wear overnight for 12 weeks.
arm group label: Un-Splinted
arm group type: No Intervention
description: Patients will not wear a night splint
intervention type: Device
intervention name: Thermoplastic Hand Splint
description: Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.
arm group label: Splinted
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Graham Cheung, MBBCh FRCS
role: Principal Investigator
affiliation: Consultant Hand Surgeon
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dupuytren Contracture
mesh term: Contracture
sharing ipd: No