<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/NCT01724853</url>
  </required_header>
  <id_info>
    <org_study_id>RASSH01</org_study_id>
    <nct_id>NCT01724853</nct_id>
  </id_info>
  <brief_title>Outcomes of Treatment for Trapeziometacarpal Osteoarthritis</brief_title>
  <acronym>RASSH</acronym>
  <official_title>Outcomes of Treatment for Trapeziometacarpal Osteoarthritis Using a Comprehensive Core Set.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schulthess Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Schulthess Klinik</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is the evaluation of the outcomes following treatment for TMC&#xD;
      OA using a set of variables covering all OMERACT categories as well as the dimensions of the&#xD;
      International Classification of Functioning, Disability and Health (ICF). Secondary aims are&#xD;
      the analysis of the determinants of patient satisfaction with the treatment result, the&#xD;
      evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ),&#xD;
      which has not yet been established in TMC OA patients, as well as the economic impact&#xD;
      associated with TMC OA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hand osteoarthritis is a frequent condition in the middle-aged and elderly population with a&#xD;
      prevalence of up to 76%. After the distal interphalangeal joints, the trapeziometacarpal&#xD;
      joints are the most affected joints of the hand. Symptoms such as pain, stiffness, deformity,&#xD;
      loss of grip strength, as well as reduction of joint mobility, are affecting the overall hand&#xD;
      function and patients' quality of life. Numerous studies have evaluated different surgical&#xD;
      and conservative interventions for treating patients with trapeziometacarpal osteoarthritis&#xD;
      (TMC OA) with both interventions found to be effective in reducing pain and increasing&#xD;
      function. To date, there is only little evidence about the characteristics and outcomes of&#xD;
      patients who receive a conservative or a surgical treatment for TMC OA. The analysis should&#xD;
      focus on which factors contribute to either a conservative or a surgical treatment, and if&#xD;
      these patients differ regarding personal or health-related factors. Furthermore, no data&#xD;
      about the economic consequences of a resection interposition suspension arthroplasty are&#xD;
      available which highlights the need for a financial analysis of this procedure with respect&#xD;
      to the benefit for the patient and cost bearers.&#xD;
&#xD;
      Besides objective parameters, such as strength and range of motion, the evaluation of patient&#xD;
      satisfaction as well as the fulfilment of preoperative expectation is becoming increasingly&#xD;
      important as outcome measures. However, there is no standardized instrument available for&#xD;
      measuring satisfaction, expectations and their fulfillment for TMC OA patients.&#xD;
&#xD;
      For measuring outcomes of OA, a core set for outcome measures for OA trials (hip, knee, hand)&#xD;
      was developed at the OMERACT III conference. It comprised of the assessment of pain, physical&#xD;
      function, patients' global condition and joint imaging. Furthermore, the evaluation of&#xD;
      quality of life is recommended, but the specific items of this core set for TMC OA patients&#xD;
      still remain to be defined.&#xD;
&#xD;
      The main objective of the study is the evaluation of the outcomes following treatment for TMC&#xD;
      OA using a set of variables covering all OMERACT categories as well as the dimensions of the&#xD;
      International Classification of Functioning, Disability and Health (ICF). Secondary aims are&#xD;
      the analysis of the determinants of patient satisfaction with the treatment result, the&#xD;
      evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ),&#xD;
      which has not yet been established in TMC OA patients, as well as the economic impact&#xD;
      associated with TMC OA.&#xD;
&#xD;
      In order to achieve these objectives, a prospective cohort study including patients with TMC&#xD;
      OA will be conducted, regardless of if they will have surgery or not. A total of 100&#xD;
      surgically treated patients will be analysed during a one-year inclusion period and all&#xD;
      conservatively treated patients will also be analysed during the same time. Follow up&#xD;
      examinations will take place at 3, 6 and 12 months for all patients using a standardized set&#xD;
      of objective as well as subjective outcome measurements including the MHQ.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Michigan Hand Questionnaire - pain subscale</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disabilities of the Arm, Shoulder and Hand Questionnaire</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">177</enrollment>
  <condition>Osteoarthrosis of the Carpometacarpal Joint of the Thumb</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Preferred surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Conservative treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Resection suspension interposition arthroplasty or Arthrodesis</description>
    <arm_group_label>Surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conservative</intervention_name>
    <description>Injection</description>
    <arm_group_label>Conservative</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients diagnosed for TMC OA&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  rheumatoid arthritis,&#xD;
&#xD;
          -  legal incompetent patients,&#xD;
&#xD;
          -  patients already included in the study for the other hand,&#xD;
&#xD;
          -  insufficient knowledge of the German language&#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>Daniel Herren, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Handsurgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miriam Marks, MSc.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Research and Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schulthess Klinik</name>
      <address>
        <city>Zurich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 28, 2013</last_update_submitted>
  <last_update_submitted_qc>November 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schulthess Klinik</investigator_affiliation>
    <investigator_full_name>Daniel Herren</investigator_full_name>
    <investigator_title>MD, MHA</investigator_title>
  </responsible_party>
  <keyword>Carpometacarpal</keyword>
  <keyword>osteoarthritis</keyword>
  <keyword>outcome measures</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/NCT01724853
org study id: RASSH01
nct id: NCT01724853
lead sponsor: 
collaborator: 
has dmc: Yes
The main objective of the study is the evaluation of the outcomes following treatment for TMC
      OA using a set of variables covering all OMERACT categories as well as the dimensions of the
      International Classification of Functioning, Disability and Health (ICF). Secondary aims are
      the analysis of the determinants of patient satisfaction with the treatment result, the
      evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ),
      which has not yet been established in TMC OA patients, as well as the economic impact
      associated with TMC OA.
Hand osteoarthritis is a frequent condition in the middle-aged and elderly population with a
      prevalence of up to 76%. After the distal interphalangeal joints, the trapeziometacarpal
      joints are the most affected joints of the hand. Symptoms such as pain, stiffness, deformity,
      loss of grip strength, as well as reduction of joint mobility, are affecting the overall hand
      function and patients' quality of life. Numerous studies have evaluated different surgical
      and conservative interventions for treating patients with trapeziometacarpal osteoarthritis
      (TMC OA) with both interventions found to be effective in reducing pain and increasing
      function. To date, there is only little evidence about the characteristics and outcomes of
      patients who receive a conservative or a surgical treatment for TMC OA. The analysis should
      focus on which factors contribute to either a conservative or a surgical treatment, and if
      these patients differ regarding personal or health-related factors. Furthermore, no data
      about the economic consequences of a resection interposition suspension arthroplasty are
      available which highlights the need for a financial analysis of this procedure with respect
      to the benefit for the patient and cost bearers.

      Besides objective parameters, such as strength and range of motion, the evaluation of patient
      satisfaction as well as the fulfilment of preoperative expectation is becoming increasingly
      important as outcome measures. However, there is no standardized instrument available for
      measuring satisfaction, expectations and their fulfillment for TMC OA patients.

      For measuring outcomes of OA, a core set for outcome measures for OA trials (hip, knee, hand)
      was developed at the OMERACT III conference. It comprised of the assessment of pain, physical
      function, patients' global condition and joint imaging. Furthermore, the evaluation of
      quality of life is recommended, but the specific items of this core set for TMC OA patients
      still remain to be defined.

      The main objective of the study is the evaluation of the outcomes following treatment for TMC
      OA using a set of variables covering all OMERACT categories as well as the dimensions of the
      International Classification of Functioning, Disability and Health (ICF). Secondary aims are
      the analysis of the determinants of patient satisfaction with the treatment result, the
      evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ),
      which has not yet been established in TMC OA patients, as well as the economic impact
      associated with TMC OA.

      In order to achieve these objectives, a prospective cohort study including patients with TMC
      OA will be conducted, regardless of if they will have surgery or not. A total of 100
      surgically treated patients will be analysed during a one-year inclusion period and all
      conservatively treated patients will also be analysed during the same time. Follow up
      examinations will take place at 3, 6 and 12 months for all patients using a standardized set
      of objective as well as subjective outcome measurements including the MHQ.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Michigan Hand Questionnaire - pain subscale
time frame: 12 months
measure: Disabilities of the Arm, Shoulder and Hand Questionnaire
time frame: 12 months
arm group label: Surgery
arm group type: Other
description: Preferred surgery
arm group label: Conservative
arm group type: Other
description: Conservative treatment
intervention type: Procedure
intervention name: Surgery
description: Resection suspension interposition arthroplasty or Arthrodesis
arm group label: Surgery
intervention type: Other
intervention name: Conservative
description: Injection
arm group label: Conservative
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Herren, Dr.
role: Principal Investigator
affiliation: Department of Handsurgery
last name: Miriam Marks, MSc.
role: Study Chair
affiliation: Department of Research and Development
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Schulthess Klinik
investigator full name: Daniel Herren
investigator title: MD, MHA
mesh term: Osteoarthritis