<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/NCT02204995</url>
  </required_header>
  <id_info>
    <org_study_id>NL48197.075.14</org_study_id>
    <secondary_id>NL48197.075.14</secondary_id>
    <nct_id>NCT02204995</nct_id>
  </id_info>
  <brief_title>Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton &amp; Glickel Stage 4</brief_title>
  <official_title>Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton &amp; Glickel Stage 4: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isala</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in&#xD;
      postmenopausal women. Many surgical treatments have been described and recent literature has&#xD;
      show that the relatively simple trapeziectomy gives equal results and less complications,&#xD;
      when compared to other techniques such as ligament reconstructions and interpositions. These&#xD;
      studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage&#xD;
      4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases&#xD;
      the chance for collapse of the first metacarpal bone and associated problems.&#xD;
&#xD;
      The investigators' hypothesis is that an LRTI can be of additional value in patients with&#xD;
      stage 4 osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Michigan Hand Outcomes Questionnaire (MHOQ)</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Michigan Hand Outcomes Questionnaire (MHOQ)</measure>
    <time_frame>5 years after surgery</time_frame>
    <description>Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Michigan Hand Outcomes Questionnaire (MHOQ)</measure>
    <time_frame>1 and 5 years after surgery</time_frame>
    <description>Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disabilities of Arm Shoulder and Hand (DASH)</measure>
    <time_frame>1 and 5 years after surgery</time_frame>
    <description>Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>1 and 5 years after surgery</time_frame>
    <description>Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thumb mobility</measure>
    <time_frame>1 and 5 years after surgery</time_frame>
    <description>Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>1 and 5 years after surgery</time_frame>
    <description>Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>1 and 5 years after surgery</time_frame>
    <description>Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Trapeziometacarpal Osteoarthritis</condition>
  <condition>Thumb Carpometacarpal Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Trapeziectomy with LRTI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trapeziectomy with Ligament Reconstruction and Tendon Interposition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trapeziectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trapeziectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trapeziectomy with LRTI</intervention_name>
    <description>Trapeziectomy with Ligament Reconstruction and Tendon Interposition</description>
    <arm_group_label>Trapeziectomy with LRTI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trapeziectomy</intervention_name>
    <description>Trapeziectomy</description>
    <arm_group_label>Trapeziectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  40 years of age or more&#xD;
&#xD;
          -  Symptomatic trapeziometacarpal osteoarthritis&#xD;
&#xD;
          -  Eaton &amp; Glickel stage 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An operation for trapeziometacarpal osteoarthritis on the same hand in the past.&#xD;
&#xD;
          -  Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with&#xD;
             contralateral hand.&#xD;
&#xD;
          -  Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis,&#xD;
             systemic lupus or gout.&#xD;
&#xD;
          -  Symptomatic carpal tunnel syndrome in same hand.&#xD;
&#xD;
          -  Symptomatic Quervain's tenosynovitis in same hand.&#xD;
&#xD;
          -  Neurological or other disorders of the affected side that can influence postoperative&#xD;
             rehabilitation.&#xD;
&#xD;
          -  Insufficient knowledge of Dutch language.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeroen H. van Uchelen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Isala</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ramon P. de Wildt, MD</last_name>
    <email>r.p.de.wildt@isala.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Isala Hospital</name>
      <address>
        <city>Zwolle</city>
        <state>Overijssel</state>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ramon P. de Wildt, MD</last_name>
      <email>r.p.de.wildt@isala.nl</email>
    </contact>
    <investigator>
      <last_name>Ramon P. de Wildt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>September 2, 2016</last_update_submitted>
  <last_update_submitted_qc>September 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isala</investigator_affiliation>
    <investigator_full_name>Ramon de Wildt</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Thumb</keyword>
  <keyword>LRTI</keyword>
  <keyword>Trapeziectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT02204995
org study id: NL48197.075.14
secondary id: NL48197.075.14
nct id: NCT02204995
lead sponsor: 
has dmc: No
Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in
      postmenopausal women. Many surgical treatments have been described and recent literature has
      show that the relatively simple trapeziectomy gives equal results and less complications,
      when compared to other techniques such as ligament reconstructions and interpositions. These
      studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage
      4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases
      the chance for collapse of the first metacarpal bone and associated problems.

      The investigators' hypothesis is that an LRTI can be of additional value in patients with
      stage 4 osteoarthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
time frame: 1 year after surgery
description: Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 year postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
time frame: 5 years after surgery
description: Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 5 years postoperatively, measured with the total score of the Michigan Hand Outcomes Questionnaire (MHOQ)?
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
time frame: 1 and 5 years after surgery
description: Is there a difference is daily hand function between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years postoperatively, measured with the different subscales (i.e. pain) of the Michigan Hand Outcomes Questionnaire (MHOQ)?
measure: Disabilities of Arm Shoulder and Hand (DASH)
time frame: 1 and 5 years after surgery
description: Is there a difference is daily hand function after 1 and 5 years postoperatively between patients with a total joint arthroplasty and patients with a trapeziectomy measured with the Disabilities of Arm Shoulder and Hand (DASH)?
measure: Grip strength
time frame: 1 and 5 years after surgery
description: Is there a difference in grip strength between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
measure: Thumb mobility
time frame: 1 and 5 years after surgery
description: Is there a difference in mobility of the thumb between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
measure: Complications
time frame: 1 and 5 years after surgery
description: Is there a difference in postoperative complications between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
measure: Return to work
time frame: 1 and 5 years after surgery
description: Is there a difference in return to work between patients with a total joint arthroplasty and patients with a trapeziectomy after 1 and 5 years?
arm group label: Trapeziectomy with LRTI
arm group type: Active Comparator
description: Trapeziectomy with Ligament Reconstruction and Tendon Interposition
arm group label: Trapeziectomy
arm group type: Active Comparator
description: Trapeziectomy
intervention type: Procedure
intervention name: Trapeziectomy with LRTI
description: Trapeziectomy with Ligament Reconstruction and Tendon Interposition
arm group label: Trapeziectomy with LRTI
intervention type: Procedure
intervention name: Trapeziectomy
description: Trapeziectomy
arm group label: Trapeziectomy
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Jeroen H. van Uchelen, MD
role: Study Chair
affiliation: Isala
last name: Ramon P. de Wildt, MD
email: r.p.de.wildt@isala.nl
facility: 
status: Recruiting
contact: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Isala
investigator full name: Ramon de Wildt
investigator title: MD
mesh term: Osteoarthritis