<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/NCT03017040</url>
  </required_header>
  <id_info>
    <org_study_id>2015P001271</org_study_id>
    <nct_id>NCT03017040</nct_id>
  </id_info>
  <brief_title>In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries</brief_title>
  <official_title>In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that there is no relationship between in vivo kinematic&#xD;
      abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries&#xD;
      (SLIL)&#xD;
&#xD;
      The secondary null hypotheses are that: There are no kinematic differences between subjects&#xD;
      with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the&#xD;
      contralateral wrist without scapholunate ligament injury.&#xD;
&#xD;
      The investigators aim to answer to the below questions:&#xD;
&#xD;
        -  What are baseline validated outcomes for subjects with SLIL injury?&#xD;
&#xD;
        -  What are baseline physical measures (range of motion, Jamar Dynamometry)?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In vivo kinematics of the normal wrist has been studied previously, but few studies have&#xD;
      characterized the wrist with a SLIL injury. There are few studies evaluating validated&#xD;
      patient-rated outcomes for patients with SLIL injury. The goal of this study would be to&#xD;
      evaluate to what degree kinematic abnormalities affect patient-rated outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not enough research staff&#xD;
  </why_stopped>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">April 27, 2018</completion_date>
  <primary_completion_date type="Actual">April 27, 2018</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Rated Wrist Evaluation (PRWE)</measure>
    <time_frame>at enrollment</time_frame>
    <description>The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SF-12 Patient Questionnaire</measure>
    <time_frame>at enrollment</time_frame>
    <description>The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DASH Questionnaire</measure>
    <time_frame>at enrollment</time_frame>
    <description>The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Scapholunate Ligament Tear</condition>
  <arm_group>
    <arm_group_label>Scapholunate tear</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Wrist</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT scan</intervention_name>
    <description>A CT scan of the wrist</description>
    <arm_group_label>Control Wrist</arm_group_label>
    <arm_group_label>Scapholunate tear</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fluoroscopy Scan</intervention_name>
    <description>A fluoroscopy scan of the wrist.</description>
    <arm_group_label>Control Wrist</arm_group_label>
    <arm_group_label>Scapholunate tear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with a unilateral full thickness scapholunate ligament tear diagnosed by&#xD;
             radiographs or advanced imaging&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a partial thickness scapholunate ligament tear&#xD;
&#xD;
          -  Patients with radiographic arthrosis&#xD;
&#xD;
          -  Patients with prior wrist injury&#xD;
&#xD;
          -  Pregnant women&#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>Neal Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>August 13, 2018</results_first_submitted>
  <results_first_submitted_qc>September 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2018</results_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Neal Chung-Jen Chen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03017040/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Scapholunate Tear</title>
          <description>Subjects with a full scapholunate (SL) tear will have a CT scan and fluoroscopy images taken. Subjects will enroll the injured wrist into the SL tear group and uninjured wrist into the control group. Thus each participant will flow into both study arms/groups and may appear to be counted twice, however, for this study we focus on number of wrists.&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
        </group>
        <group group_id="P2">
          <title>Control Wrist</title>
          <description>Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control. Subjects will enroll the injured wrist into the SL tear group and uninjured wrist into the control group. Thus each participant will flow into both study arms/groups and may appear to be counted twice, however, for this study we focus on number of wrists.&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1">Participants enroll one wrist into each group,thus, one participant flows into both groups.</participants>
                <participants group_id="P2" count="1">Participants enroll one wrist into each group,thus, one participant flows into both groups.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One subject accounts for scapholunate tear and control wrist, i.e., one subject enrolled for two study wrists.</population>
      <group_list>
        <group group_id="B1">
          <title>Participants With Unilateral Scapholunate Tear</title>
          <description>All subjects with a full scapholunate (SL) tear will have a CT scan and fluoroscopy images taken. The injured wrist will enroll in the SL tear group and the uninjured wrist as the control wrist.&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47" lower_limit="47" upper_limit="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Rated Wrist Evaluation (PRWE)</title>
        <description>The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.</description>
        <time_frame>at enrollment</time_frame>
        <population>The paper-based questionnaire was not scored and tallied, thus not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Scapholunate Tear</title>
            <description>Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
          </group>
          <group group_id="O2">
            <title>Control Wrist</title>
            <description>Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Rated Wrist Evaluation (PRWE)</title>
          <description>The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.</description>
          <population>The paper-based questionnaire was not scored and tallied, thus not analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>SF-12 Patient Questionnaire</title>
        <description>The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities</description>
        <time_frame>at enrollment</time_frame>
        <population>The paper-based questionnaire was not scored and tallied, thus not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Scapholunate Tear</title>
            <description>Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
          </group>
          <group group_id="O2">
            <title>Control Wrist</title>
            <description>Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
          </group>
        </group_list>
        <measure>
          <title>SF-12 Patient Questionnaire</title>
          <description>The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities</description>
          <population>The paper-based questionnaire was not scored and tallied, thus not analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DASH Questionnaire</title>
        <description>The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.</description>
        <time_frame>at enrollment</time_frame>
        <population>The paper-based questionnaire was not scored and tallied, thus not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Scapholunate Tear</title>
            <description>Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
          </group>
          <group group_id="O2">
            <title>Control Wrist</title>
            <description>Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
          </group>
        </group_list>
        <measure>
          <title>DASH Questionnaire</title>
          <description>The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.</description>
          <population>The paper-based questionnaire was not scored and tallied, thus not analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Scapholunate Tear</title>
          <description>Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
        </group>
        <group group_id="E2">
          <title>Control Wrist</title>
          <description>Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.&#xD;
CT scan: A CT scan of the wrist&#xD;
Fluoroscopy Scan: A fluoroscopy scan of the wrist.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Neal Chen</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-4700</phone>
      <email>nchen1@mgh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03017040
org study id: 2015P001271
nct id: NCT03017040
lead sponsor: 
has dmc: No
The investigators hypothesize that there is no relationship between in vivo kinematic
      abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries
      (SLIL)

      The secondary null hypotheses are that: There are no kinematic differences between subjects
      with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the
      contralateral wrist without scapholunate ligament injury.

      The investigators aim to answer to the below questions:

        -  What are baseline validated outcomes for subjects with SLIL injury?

        -  What are baseline physical measures (range of motion, Jamar Dynamometry)?
In vivo kinematics of the normal wrist has been studied previously, but few studies have
      characterized the wrist with a SLIL injury. There are few studies evaluating validated
      patient-rated outcomes for patients with SLIL injury. The goal of this study would be to
      evaluate to what degree kinematic abnormalities affect patient-rated outcomes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient Rated Wrist Evaluation (PRWE)
time frame: at enrollment
description: The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.
measure: SF-12 Patient Questionnaire
time frame: at enrollment
description: The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities
measure: DASH Questionnaire
time frame: at enrollment
description: The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.
arm group label: Scapholunate tear
arm group type: Experimental
description: Subjects with a full scapholunate tear will have a CT scan and fluoroscopy images taken
arm group label: Control Wrist
arm group type: Active Comparator
description: Subjects will have a CT scan and fluoroscopy image taken of the contralateral wrist serve as the control.
intervention type: Device
intervention name: CT scan
description: A CT scan of the wrist
arm group label: Control Wrist
arm group label: Scapholunate tear
intervention type: Device
intervention name: Fluoroscopy Scan
description: A fluoroscopy scan of the wrist.
arm group label: Control Wrist
arm group label: Scapholunate tear
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neal Chen, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Neal Chung-Jen Chen
investigator title: Principal Investigator
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 