xml: <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/NCT05980793</url>
    </required_header>
    <id_info>
      <org_study_id>DOPS</org_study_id>
      <nct_id>NCT05980793</nct_id>
    </id_info>
    <brief_title>Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)</brief_title>
    <official_title>Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Stockholm South General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Karolinska Institutet</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 goal of this clinical trial is to compare the effects of a surgical and a non-surgical&#xD;
        treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint.&#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Are the treatments effective?&#xD;
  &#xD;
          -  Is the surgical treatment more effective than the non-surgical treatment? Participants&#xD;
             will receive surgical treatment (PIP joint denervation) or non surgical treatment&#xD;
             (patient education plus exercise).&#xD;
  &#xD;
        Researchers will compare the non-surgical and surgical groups to see if pain,&#xD;
        patient-reported function, quality of life, movement and grip strength differs between the&#xD;
        groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a parallel group, two-arm, randomized, controlled trial comparing the effects of&#xD;
        surgical denevation to patient education plus exercise in patients with symptomatic PIP joint&#xD;
        osteoarthritis.&#xD;
  &#xD;
        The research questions are:&#xD;
  &#xD;
          1. Does any of the treatments denervation of the PIP-joint and patient education plus&#xD;
             exercise decrease pain, improve patient-reported outcomes, grip strength and range of&#xD;
             motion (ROM) in PIP-joint osteoarthritis?&#xD;
  &#xD;
          2. Does denervation of the PIP-joint decrease pain, and improve patient-reported outcomes&#xD;
             grip strength and ROM more effectively than patient education plus exercise for&#xD;
             PIP-joint osteoarthritis?&#xD;
  &#xD;
        Participants will be randomly assigned (1:1) to receive surgical denervation of the PIP-joint&#xD;
        or education plus exercise. A block randomization scheme with a fixed block size of 10 will&#xD;
        be used. Patients will be stratified according to gender. Sealed opaque envelopes will be&#xD;
        used and data analysts will be masked for treatment allocation.&#xD;
  &#xD;
        Assesments will be made at inclusion, and after 3, 6 and 12 months. The studys primary&#xD;
        enpoint is 12 months after intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">July 15, 2029</completion_date>
    <primary_completion_date type="Anticipated">July 15, 2028</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>A parallel group, two-arm, randomized, controlled trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Data analysts will be masked for treatment allocation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain on load (change baseline to -12 months)</measure>
      <time_frame>0-12 months</time_frame>
      <description>Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain at rest (change baseline to -3, -6, -12 months)</measure>
      <time_frame>0-12 months</time_frame>
      <description>Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months</measure>
      <time_frame>0-12 months</time_frame>
      <description>A questionnaire used by Swedish Healthcare Quality Registry for hand surgery (HAKIR), 0-100 points, 100 is a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months</measure>
      <time_frame>0-12 months</time_frame>
      <description>A questionnaire that measures hand/wrist function (0-100 points, 100 is a worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ5D-5L change baseline to -3, -6, -12 months</measure>
      <time_frame>0-12 months</time_frame>
      <description>A questionnaire that measures quality of life (0-1 point, 0 is a worse outcome).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective function change baseline to -3, -6, -12 months</measure>
      <time_frame>0-12 months</time_frame>
      <description>Range of motion (goniometer with 5 degrees interval)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective function change baseline to -3, -6, -12 months</measure>
      <time_frame>0-12 months</time_frame>
      <description>grip strength (hydraulic hand dynamometer, kilograms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>0-12 months</time_frame>
      <description>2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>0-12 months</time_frame>
      <description>Mini Sollerman (0-12 points, 12 indicating a better outcome)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>0-12 months</time_frame>
      <description>Infection (clinical evaluation, positive cultures, need for antibiotics)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Additional treatment</measure>
      <time_frame>0-12 months</time_frame>
      <description>Need for further surgery/treatment</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Osteoarthritis Finger</condition>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Surgical treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PIP joint denervation is performed through a volar approach.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-surgical treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>An education and exercise program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PIP joint denervation</intervention_name>
      <description>Surgical denervation of the PIP joint</description>
      <arm_group_label>Surgical treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Patient education plus exercise</intervention_name>
      <description>An education plus exercise program</description>
      <arm_group_label>Non-surgical treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years.&#xD;
  &#xD;
            -  Chronic symptomatic osteoarthritis in the PIP-joint.&#xD;
  &#xD;
            -  Radiological signs of osteoarthritis on posteroanterior and lateral radiographs&#xD;
               assessed by the Kellgren-Lawrence classification (grade II-IV) (Kellgren &amp; Lawrence,&#xD;
               1957).&#xD;
  &#xD;
            -  Clinical signs of PIP-joint arthritis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inflammatory arthritis.&#xD;
  &#xD;
            -  Ongoing infection in the hand.&#xD;
  &#xD;
            -  Inability to co-operate with the follow-up protocol.&#xD;
  &#xD;
            -  Intra-articular glucocorticoid, PRP or Hyaluronic acid injections in the affected&#xD;
               joint less than 3 months prior to enrollment.&#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>Elin Sward, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Hand Surgery Sodersjukhuset and Karolinska Institutet</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elin Sward, MD, PhD</last_name>
      <phone>+46812361000</phone>
      <email>elin.sward@regionstockholm.se</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
      <investigator_full_name>Elin Swärd</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980793
  org study id: DOPS
  nct id: NCT05980793
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effects of a surgical and a non-surgical
        treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint.
        The main questions it aims to answer are:
  
          -  Are the treatments effective?
  
          -  Is the surgical treatment more effective than the non-surgical treatment? Participants
             will receive surgical treatment (PIP joint denervation) or non surgical treatment
             (patient education plus exercise).
  
        Researchers will compare the non-surgical and surgical groups to see if pain,
        patient-reported function, quality of life, movement and grip strength differs between the
        groups.
  This is a parallel group, two-arm, randomized, controlled trial comparing the effects of
        surgical denevation to patient education plus exercise in patients with symptomatic PIP joint
        osteoarthritis.
  
        The research questions are:
  
          1. Does any of the treatments denervation of the PIP-joint and patient education plus
             exercise decrease pain, improve patient-reported outcomes, grip strength and range of
             motion (ROM) in PIP-joint osteoarthritis?
  
          2. Does denervation of the PIP-joint decrease pain, and improve patient-reported outcomes
             grip strength and ROM more effectively than patient education plus exercise for
             PIP-joint osteoarthritis?
  
        Participants will be randomly assigned (1:1) to receive surgical denervation of the PIP-joint
        or education plus exercise. A block randomization scheme with a fixed block size of 10 will
        be used. Patients will be stratified according to gender. Sealed opaque envelopes will be
        used and data analysts will be masked for treatment allocation.
  
        Assesments will be made at inclusion, and after 3, 6 and 12 months. The studys primary
        enpoint is 12 months after intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A parallel group, two-arm, randomized, controlled trial.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Data analysts will be masked for treatment allocation
  measure: Pain on load (change baseline to -12 months)
  time frame: 0-12 months
  description: Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
  measure: Pain at rest (change baseline to -3, -6, -12 months)
  time frame: 0-12 months
  description: Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
  measure: HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months
  time frame: 0-12 months
  description: A questionnaire used by Swedish Healthcare Quality Registry for hand surgery (HAKIR), 0-100 points, 100 is a worse outcome.
  measure: PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months
  time frame: 0-12 months
  description: A questionnaire that measures hand/wrist function (0-100 points, 100 is a worse outcome)
  measure: EQ5D-5L change baseline to -3, -6, -12 months
  time frame: 0-12 months
  description: A questionnaire that measures quality of life (0-1 point, 0 is a worse outcome).
  measure: Objective function change baseline to -3, -6, -12 months
  time frame: 0-12 months
  description: Range of motion (goniometer with 5 degrees interval)
  measure: Objective function change baseline to -3, -6, -12 months
  time frame: 0-12 months
  description: grip strength (hydraulic hand dynamometer, kilograms)
  measure: Complications
  time frame: 0-12 months
  description: 2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)
  measure: Complications
  time frame: 0-12 months
  description: Mini Sollerman (0-12 points, 12 indicating a better outcome)
  measure: Complications
  time frame: 0-12 months
  description: Infection (clinical evaluation, positive cultures, need for antibiotics)
  measure: Additional treatment
  time frame: 0-12 months
  description: Need for further surgery/treatment
  arm group label: Surgical treatment
  arm group type: Active Comparator
  description: PIP joint denervation is performed through a volar approach.
  arm group label: Non-surgical treatment
  arm group type: Active Comparator
  description: An education and exercise program.
  intervention type: Procedure
  intervention name: PIP joint denervation
  description: Surgical denervation of the PIP joint
  arm group label: Surgical treatment
  intervention type: Procedure
  intervention name: Patient education plus exercise
  description: An education plus exercise program
  arm group label: Non-surgical treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elin Sward, MD, PhD
  role: Principal Investigator
  affiliation: Department of Hand Surgery Sodersjukhuset and Karolinska Institutet
  last name: Elin Sward, MD, PhD
  phone: +46812361000
  email: elin.sward@regionstockholm.se
  responsible party type: Principal Investigator
  investigator affiliation: Karolinska Institutet
  investigator full name: Elin Swärd
  investigator title: MD, PhD
  mesh term: Osteoarthritis
  sharing ipd: No