<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/NCT02210676</url>
  </required_header>
  <id_info>
    <org_study_id>2014P001041</org_study_id>
    <nct_id>NCT02210676</nct_id>
  </id_info>
  <brief_title>Residual Extensor Lag Approximately 1 Month After Splint or Cast Immobilization of a Mallet Finger</brief_title>
  <official_title>Residual Extensor Lag Approximately 1 Month After Splint or Cast Immobilization of a Mallet Finger</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>
      Aim:&#xD;
&#xD;
      The purpose of the study is to learn more about how a person recovers after treatment for&#xD;
      mallet finger injury. The investigators want to identify the best outcome after mallet finger&#xD;
      injury and how to improve treatment strategies.&#xD;
&#xD;
      Primary null hypothesis:&#xD;
&#xD;
      There are no statistically significant factors associated with extensor lag between 4 weeks&#xD;
      and 4 months after immobilization is discontinued for a mallet finger among demographic,&#xD;
      injury, and treatment factors.&#xD;
&#xD;
      Secondary null hypothesis:&#xD;
&#xD;
      There are no statistically significant factors associated with PROMIS upper extremity&#xD;
      function between 4 weeks and 4 months after completion of immobilization for a mallet finger&#xD;
      among demographic, psychological, injury, and treatment factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to the investigator leaving the institution, the study was terminated&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mallet Finger Extensor Lag</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mallet Finger Extensor Lag</measure>
    <time_frame>4 weeks to 4 months after diagnosis</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes Measure Information System (PROMIS) Upper Extremity</measure>
    <time_frame>4 weeks to 4 months after diagnosis</time_frame>
    <description>A computerized assessment of upper extremity function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likert Pain Scale</measure>
    <time_frame>4 weeks to 4 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographics Questionnaire</measure>
    <time_frame>4 weeks to 4 months after diagnosis</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Patients Present With Mallet Finger</condition>
  <arm_group>
    <arm_group_label>Patients with Mallet Finger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROMIS Upper Extremity</intervention_name>
    <arm_group_label>Patients with Mallet Finger</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Likert Pain Scale</intervention_name>
    <arm_group_label>Patients with Mallet Finger</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mallet Finger Extensor Lag Measurement</intervention_name>
    <arm_group_label>Patients with Mallet Finger</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  English fluency and literacy&#xD;
&#xD;
          -  Mallet finger fracture or non-fracture&#xD;
&#xD;
          -  Mallet finger subluxation or non-subluxation&#xD;
&#xD;
        Exclusion Criteria:&#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>David Ring, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>David C. Ring, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT02210676
org study id: 2014P001041
nct id: NCT02210676
lead sponsor: 
has dmc: No
Aim:

      The purpose of the study is to learn more about how a person recovers after treatment for
      mallet finger injury. The investigators want to identify the best outcome after mallet finger
      injury and how to improve treatment strategies.

      Primary null hypothesis:

      There are no statistically significant factors associated with extensor lag between 4 weeks
      and 4 months after immobilization is discontinued for a mallet finger among demographic,
      injury, and treatment factors.

      Secondary null hypothesis:

      There are no statistically significant factors associated with PROMIS upper extremity
      function between 4 weeks and 4 months after completion of immobilization for a mallet finger
      among demographic, psychological, injury, and treatment factors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Mallet Finger Extensor Lag
time frame: Baseline
measure: Mallet Finger Extensor Lag
time frame: 4 weeks to 4 months after diagnosis
measure: Patient Reported Outcomes Measure Information System (PROMIS) Upper Extremity
time frame: 4 weeks to 4 months after diagnosis
description: A computerized assessment of upper extremity function
measure: Likert Pain Scale
time frame: 4 weeks to 4 months after diagnosis
measure: Demographics Questionnaire
time frame: 4 weeks to 4 months after diagnosis
arm group label: Patients with Mallet Finger
arm group type: Experimental
description: All enrolled patients
intervention type: Other
intervention name: PROMIS Upper Extremity
arm group label: Patients with Mallet Finger
intervention type: Other
intervention name: Likert Pain Scale
arm group label: Patients with Mallet Finger
intervention type: Other
intervention name: Mallet Finger Extensor Lag Measurement
arm group label: Patients with Mallet Finger
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Ring, MD PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: David C. Ring, MD
investigator title: Principal Investigator