<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/NCT01679717</url>
  </required_header>
  <id_info>
    <org_study_id>H4/2012</org_study_id>
    <nct_id>NCT01679717</nct_id>
  </id_info>
  <brief_title>Postoperative Therapy After Interposition Arthroplasty in CMC1</brief_title>
  <official_title>Postoperative Therapy After Interposition Arthroplasty in CMC1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diakonhjemmet Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Norwegian Women´s Public Health Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Diakonhjemmet Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this randomized controlled trial the investigators want to investigate whether early&#xD;
      versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a&#xD;
      faster recovery of hand function. The investigators also want to explore patients'&#xD;
      satisfaction with the two different treatment regimes. The participants in the control group&#xD;
      will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in&#xD;
      a splint for six weeks. The participants in the intervention group will use a soft splint for&#xD;
      six weeks, but will be instructed to remove the splint daily to perform exercises for the&#xD;
      thumb. A total of 70 patients will be included in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>The COPM-assessment starts with an interview, addressing patient specific Hand Osteoarthritis (HOA)-related activity limitations within the areas self-care, productivity and leisure. The patient will thereafter rate the five most important activities for performance and satisfaction with performance, on 1 to 10-point scales (higher scores reflect better performance or higher satisfaction). The Norwegian version of the COPM has been tested for validity, reliability and responsiveness and has demonstrated good ability to detect functional changes in HOA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>Each patient will be asked to complete a Numeric Rating Scale in order to give an opinion about their postoperative treatment regimen (splint-use, hand function, pain in the thumb, thumb movement and satisfaction with the operation).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure for activity performance (MAP-hand).</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>MAP-hand is a questionnaire consisting of questions about 18 standardised activities. The patients will be instructed to score their ability to perform the activities on a scale from 1(No difficulty)to 4 (Not able to do). The Norwegian version of the MAP-hand has been tested for validity, reliability and responsiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip force and pinch grip</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>The electronical instrument Grippit will be used to measure grip force and pinch grip. In Grippit, force recordings in Newtons (N) are displayed on the electronic unit every 0.5 seconds over a period of 10 seconds. The peak and average of the 20 registrations, as well as the final value (last recording) will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint mobility</measure>
    <time_frame>Baseline, 3, 6 and 12 months</time_frame>
    <description>The flexion deficit of fingers 2 - 5 will be assessed by measuring the distance between the distal nail and the proximal crease inside the hand in millimeters.&#xD;
Range of motion in the thumbs metacarpophalangeal and interphalangeal joints will be measured with a goniometer.&#xD;
The palmar abduction of the CMC1 and of the entire thumb will be measured with the Pollexograph.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Baseline, 3, 6, and 12 months</time_frame>
    <description>Pain will be measured on a numeric rating scale (NRS), (0-10, 0=no pain), by asking the patients to mark the level of pain experienced both while they are resting and during resisted motion when measuring grip force and pinch grip.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Training diary</measure>
    <time_frame>Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.</time_frame>
    <description>The patients will be asked to report which date they performed exercises, which exercises they performed and how much pain they experienced after performing the exercises. They will also be encouraged to write down their own comments /reflections regarding the training.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Thumb Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Early mobilisation after CMC1-surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mobilisation at two weeks after operation. The participants will wear a soft splint for six weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative treatment after CMC1-surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Current standard procedure: Mobilisation at six weeks after operation. The participants will wear a rigid splint for six weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early mobilisation after CMC1-surgery</intervention_name>
    <description>Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.</description>
    <arm_group_label>Conservative treatment after CMC1-surgery</arm_group_label>
    <arm_group_label>Early mobilisation after CMC1-surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.&#xD;
&#xD;
          -  Planned surgery(interposition arthroplasty) in CMC1&#xD;
&#xD;
          -  Ability to communicate in Norwegian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgery involving other joints of the hand in addition to CMC1.&#xD;
&#xD;
          -  Previous surgery of the same thumb.&#xD;
&#xD;
          -  Other diseases og injuries that could influence hand function.&#xD;
&#xD;
          -  Mental or cognitive deficit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingvild Kjeken, Ph.d</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Rheumatology, Diakonhjemmet hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tove Nilsen, MSc</last_name>
    <phone>+47 22451500</phone>
    <email>tove.nilsen@diakonsyk.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ingvild Kjeken, PhD</last_name>
    <phone>+47 22451500</phone>
    <email>ingvild.kjeken@diakonsyk.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Diakonhjemmet hospital</name>
      <address>
        <city>Oslo</city>
        <zip>N-0370</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tove Nilsen, MSc</last_name>
      <phone>+47 22451500</phone>
      <email>tove.nilsen@diakonsyk.no</email>
    </contact>
    <contact_backup>
      <last_name>Ingvild Kjeken, PhD</last_name>
      <phone>+47 22451500</phone>
      <email>ingvild.kjeken@diakonsyk.no</email>
    </contact_backup>
    <investigator>
      <last_name>Tove Nilsen, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>May 4, 2015</last_update_submitted>
  <last_update_submitted_qc>May 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diakonhjemmet Hospital</investigator_affiliation>
    <investigator_full_name>Tove Nilsen</investigator_full_name>
    <investigator_title>Occupational therapist MSc</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>CMC1-joint</keyword>
  <keyword>Postoperative therapy</keyword>
  <keyword>Interposition arthroplasty of the thumb</keyword>
  <keyword>Occupational therapy</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/NCT01679717
org study id: H4/2012
nct id: NCT01679717
lead sponsor: 
collaborator: 
has dmc: Yes
In this randomized controlled trial the investigators want to investigate whether early
      versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a
      faster recovery of hand function. The investigators also want to explore patients'
      satisfaction with the two different treatment regimes. The participants in the control group
      will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in
      a splint for six weeks. The participants in the intervention group will use a soft splint for
      six weeks, but will be instructed to remove the splint daily to perform exercises for the
      thumb. A total of 70 patients will be included in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.
time frame: Baseline, 3, 6 and 12 months
description: The COPM-assessment starts with an interview, addressing patient specific Hand Osteoarthritis (HOA)-related activity limitations within the areas self-care, productivity and leisure. The patient will thereafter rate the five most important activities for performance and satisfaction with performance, on 1 to 10-point scales (higher scores reflect better performance or higher satisfaction). The Norwegian version of the COPM has been tested for validity, reliability and responsiveness and has demonstrated good ability to detect functional changes in HOA.
measure: Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.
time frame: Baseline, 3, 6 and 12 months
description: Each patient will be asked to complete a Numeric Rating Scale in order to give an opinion about their postoperative treatment regimen (splint-use, hand function, pain in the thumb, thumb movement and satisfaction with the operation).
measure: Measure for activity performance (MAP-hand).
time frame: Baseline, 3, 6 and 12 months
description: MAP-hand is a questionnaire consisting of questions about 18 standardised activities. The patients will be instructed to score their ability to perform the activities on a scale from 1(No difficulty)to 4 (Not able to do). The Norwegian version of the MAP-hand has been tested for validity, reliability and responsiveness.
measure: Grip force and pinch grip
time frame: Baseline, 3, 6 and 12 months
description: The electronical instrument Grippit will be used to measure grip force and pinch grip. In Grippit, force recordings in Newtons (N) are displayed on the electronic unit every 0.5 seconds over a period of 10 seconds. The peak and average of the 20 registrations, as well as the final value (last recording) will be recorded.
measure: Joint mobility
time frame: Baseline, 3, 6 and 12 months
description: The flexion deficit of fingers 2 - 5 will be assessed by measuring the distance between the distal nail and the proximal crease inside the hand in millimeters.
Range of motion in the thumbs metacarpophalangeal and interphalangeal joints will be measured with a goniometer.
The palmar abduction of the CMC1 and of the entire thumb will be measured with the Pollexograph.
measure: Pain
time frame: Baseline, 3, 6, and 12 months
description: Pain will be measured on a numeric rating scale (NRS), (0-10, 0=no pain), by asking the patients to mark the level of pain experienced both while they are resting and during resisted motion when measuring grip force and pinch grip.
measure: Training diary
time frame: Intervention group: 2-6 weeks and 3-4 months. Control group: 6-10 weeks and 3-4 months.
description: The patients will be asked to report which date they performed exercises, which exercises they performed and how much pain they experienced after performing the exercises. They will also be encouraged to write down their own comments /reflections regarding the training.
arm group label: Early mobilisation after CMC1-surgery
arm group type: Active Comparator
description: Mobilisation at two weeks after operation. The participants will wear a soft splint for six weeks.
arm group label: Conservative treatment after CMC1-surgery
arm group type: Other
description: Current standard procedure: Mobilisation at six weeks after operation. The participants will wear a rigid splint for six weeks.
intervention type: Other
intervention name: Early mobilisation after CMC1-surgery
description: Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.
arm group label: Conservative treatment after CMC1-surgery
arm group label: Early mobilisation after CMC1-surgery
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ingvild Kjeken, Ph.d
role: Study Chair
affiliation: Department of Rheumatology, Diakonhjemmet hospital
last name: Tove Nilsen, MSc
phone: +47 22451500
email: tove.nilsen@diakonsyk.no
last name: Ingvild Kjeken, PhD
phone: +47 22451500
email: ingvild.kjeken@diakonsyk.no
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Diakonhjemmet Hospital
investigator full name: Tove Nilsen
investigator title: Occupational therapist MSc
mesh term: Osteoarthritis