<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/NCT02993848</url>
  </required_header>
  <id_info>
    <org_study_id>CON48716</org_study_id>
    <nct_id>NCT02993848</nct_id>
  </id_info>
  <brief_title>North American Scapula Consortium</brief_title>
  <acronym>NASCon</acronym>
  <official_title>North American Scapula Consortium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North American Scapula Consortium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DePuy Synthes</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>North American Scapula Consortium</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The North American Scapula Consortium (NASCon) is a multi-center injury specific outcomes&#xD;
      registry.&#xD;
&#xD;
      There currently exists a paucity of outcomes data in the literature on this patient&#xD;
      population. The NASCon registry will be a resource in which investigators can conduct&#xD;
      adequately powered clinical outcomes research resulting in higher quality research with&#xD;
      meaningful results, improved patient care, and evidence-based advancement for the treatment&#xD;
      of scapula fractures. Registries can lead to significant discoveries in comparative&#xD;
      effectiveness specifically in areas where randomized control studies are not possible.&#xD;
      Collecting post-treatment (operative and non-operative) patient outcome data for similar&#xD;
      injury patterns has been shown effective in uncovering optimal standards for treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Number of Subjects:&#xD;
&#xD;
      Estimated&#xD;
&#xD;
      Year 1 10 Sites 80 Subjects Enrolled&#xD;
&#xD;
      Year 2 13 Sites 130 Subjects Enrolled&#xD;
&#xD;
      Year 3 16 Sites 170 Subjects Enrolled&#xD;
&#xD;
      Year 4 and on going 200 Subjects per year&#xD;
&#xD;
      The North American Scapula Consortium, NASCon is a multi center injury specific outcomes&#xD;
      registry. Patients presenting to participating surgeons with Extra Articular and/or Intra&#xD;
      Articular scapula fracture meeting inclusion criteria will be asked for their signed consent&#xD;
      to participate in the outcomes registry regardless of treatment plan (operative or&#xD;
      non-operative).&#xD;
&#xD;
      Justification for stated number of subjects:&#xD;
&#xD;
      The goal of this study is to capture as many patients meeting inclusion criteria from the&#xD;
      enrolling sites as possible. The investigators estimate this to be between 10 and 13 patients&#xD;
      per site, per year.&#xD;
&#xD;
      Participating sites: Participating sites will be identified based on their experience and&#xD;
      expertise in scapula repair, their interest in research, and their desire to advance&#xD;
      knowledge and continuing education in this area. Initially, Dr. Peter Cole will personally&#xD;
      invite new sites. Future site recruitment will be approved by Dr. Peter Cole and a selected&#xD;
      board. Sites must have the necessary research infrastructure and be willing and able to&#xD;
      follow all rules and regulations associated with Human Research requirements. They will be&#xD;
      required to submit evidence of site IRB approval prior to initiation.&#xD;
&#xD;
      Data Collection:&#xD;
&#xD;
      Time point: Day 0&#xD;
&#xD;
      Activity: obtain patient consent, x-rays, chart review, data pull from electronic medical&#xD;
      record&#xD;
&#xD;
      Activity conducted by: study coordinator at participating NASCon site&#xD;
&#xD;
      Time point: 6 wks , 3 mos, 6 mos, 12 mos, 24 mos&#xD;
&#xD;
      Activity: patient questionnaires, Range of Motion, Strength, and x-rays&#xD;
&#xD;
      The following is a list of demographic and treatment variables that will be collected during&#xD;
      the patient's initial enrollment visit as well as from the patient's EMR:&#xD;
&#xD;
      Demographics: Gender, date of birth, dominant hand&#xD;
&#xD;
      Injury: Inclusion indication, radiographic image, date of injury, mechanism of injury, side&#xD;
      of scapular injury, ipsilateral UE fractures, other SSSC lesions, other system injuries, Ada&#xD;
      &amp; AO/OTA Classifications, prior treatment, and workman's compensation status.&#xD;
&#xD;
      Surgical Data (when applicable): Date of surgery, operative time, estimated blood loss, other&#xD;
      procedures, subsequent shoulder procedures required, scapula operative approach, type of&#xD;
      implant.&#xD;
&#xD;
      The following is a list of outcome variables that will be collected during each follow-up&#xD;
      clinic visit as well as from the patient's EMR:&#xD;
&#xD;
      General Information: Physical Therapy, activity level, return to work, pain/pain medication,&#xD;
      complications, subsequent procedures, radiographic image.&#xD;
&#xD;
      Range of Motion:&#xD;
&#xD;
      A 14 inch goniometer will be used to evaluate flexion, abduction, external rotation, internal&#xD;
      rotation on injured and contralateral shoulder.&#xD;
&#xD;
      Strength:&#xD;
&#xD;
      A handheld dynamometer (MicroFET 2, Hoggan Health Industries, Draper, Utah), which has been&#xD;
      previously published as a reliable technique10, will assess strength in shoulder flexion,&#xD;
      abduction, and external rotation on injured and contralateral shoulder.&#xD;
&#xD;
      Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH). 11&#xD;
&#xD;
      The DASH was developed to measure physical disability and symptoms of the upper extremities&#xD;
      in people with upper extremity disorders (hand, wrist, elbow, and shoulder). It is a 30-item&#xD;
      scale that addresses difficulty in performing various physical activities that require upper&#xD;
      extremity function, stiffness, and impact of disability and symptoms on social activities,&#xD;
      work, sleep, and psychological well-being. The score ranges from 0 to 100, where 0 is&#xD;
      equivalent to no disability and 100 is equivalent to most severe disability. The DASH is a&#xD;
      validated instrument with established normative and minimal clinically important difference.&#xD;
&#xD;
      SF-12v2&#xD;
&#xD;
      The SF-12v2 is a multipurpose, short-form health survey with 12 questions. The SF-12v2 was&#xD;
      developed in 1994 by The Health Institute as a shortened version of the SF-36 health survey.&#xD;
      It yields an eight-scale profile of scores as well as physical and mental health summary&#xD;
      measures. The eight scales include: physical functioning, role of physical functioning,&#xD;
      mental functioning, role of mental functioning, social function, bodily pain, vitality, and&#xD;
      general health. It is a generic measure, as opposed to one that targets a specific age,&#xD;
      disease, or treatment group.&#xD;
&#xD;
      Reporting of Results:&#xD;
&#xD;
      Demographic data, treatment details, and outcome variables will be summarized through&#xD;
      frequencies and proportions, if they are categorical, or through measures of central tendency&#xD;
      (e.g., mean, median) and dispersion (e.g. standard deviation, quartiles) if they are&#xD;
      continuous. Quarterly registry reporting will include enrollment rates, follow-up capture&#xD;
      rates, descriptive summaries of demographic, surgical and outcomes data as well as a&#xD;
      description of any safety events for which the membership or the sponsors should be made&#xD;
      aware. Reports will be shared with the membership and study sponsors on a minimum of an&#xD;
      annual basis.&#xD;
&#xD;
      Publication and presentation of outcomes is expected in peer-reviewed orthopaedic journals&#xD;
      and symposia, once substantial data collection and outcomes of ≥1 year post-injury are&#xD;
      accomplished. Additionally, opportunities to describe the establishment of an injury specific&#xD;
      consortium and registry, including experience, process and tools utilized in the development&#xD;
      of such a registry, may be pursued by the membership.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Data Submission measured by total number of participating sites and patient enrollment</measure>
    <time_frame>Three years</time_frame>
    <description>Anticipated:&#xD;
Year 1 - 10 Sites,80 Subjects Enrolled Year 2 - 13 Sites, 130 Subjects Enrolled Year 3 - 16 Sites, 170 Subjects Enrolled</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optimization of data submission and data collected by statistician review of exported data collection</measure>
    <time_frame>Biannual review (June 2017, Dec 2017, June 2018, Dec 2018, June 2019, Dec 2019-end date)</time_frame>
    <description>A qualified statistician will review all data submitted biannually and determine the percent of unpopulated fields and provide strategy for optimizing data collection. Sites will be notified of missing data and strongly encourages to complete.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Scapular Fracture</condition>
  <arm_group>
    <arm_group_label>Operative Scapula Fracture</arm_group_label>
    <description>No intervention. Inclusion criteria and data collection is the same for both cohort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Operative Scapula Fracture</arm_group_label>
    <description>No intervention. Inclusion criteria and data collection is the same for both cohort.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>Non-Operative Scapula Fracture</arm_group_label>
    <arm_group_label>Operative Scapula Fracture</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The NASCon registry will include all qualifying, consented scapula fracture patients who&#xD;
        present to the participating site PI's clinics or practices for treatment of a scapula&#xD;
        fracture. All site PIs will use the same standardized measurement tools (Glenopolar angle,&#xD;
        Medialization, and Angulation) to evaluate participants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 yrs of age&#xD;
&#xD;
          -  Operative and non-operative fractures meeting any one of the following criteria:&#xD;
&#xD;
               -  Extra - Articular fracture indication (one or more of the following): Glenopolar&#xD;
                  angle &lt;30°, Medialization &gt;1cm, and Angulation &gt;30°&#xD;
&#xD;
               -  Intra-Articular fracture indication: &gt;2mm&#xD;
&#xD;
               -  Patient signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients meeting operative criteria that are not able to understand the consent for&#xD;
             research&#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>Peter A Cole, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Minnesota</investigator_affiliation>
    <investigator_full_name>Peter A Cole, MD</investigator_full_name>
    <investigator_title>Chair, Orthopaedic Dept., Regions Hospital; Professor, University of Minnesota</investigator_title>
  </responsible_party>
  <keyword>Scapula</keyword>
  <keyword>Fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02993848
org study id: CON48716
nct id: NCT02993848
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The North American Scapula Consortium (NASCon) is a multi-center injury specific outcomes
      registry.

      There currently exists a paucity of outcomes data in the literature on this patient
      population. The NASCon registry will be a resource in which investigators can conduct
      adequately powered clinical outcomes research resulting in higher quality research with
      meaningful results, improved patient care, and evidence-based advancement for the treatment
      of scapula fractures. Registries can lead to significant discoveries in comparative
      effectiveness specifically in areas where randomized control studies are not possible.
      Collecting post-treatment (operative and non-operative) patient outcome data for similar
      injury patterns has been shown effective in uncovering optimal standards for treatment.
Number of Subjects:

      Estimated

      Year 1 10 Sites 80 Subjects Enrolled

      Year 2 13 Sites 130 Subjects Enrolled

      Year 3 16 Sites 170 Subjects Enrolled

      Year 4 and on going 200 Subjects per year

      The North American Scapula Consortium, NASCon is a multi center injury specific outcomes
      registry. Patients presenting to participating surgeons with Extra Articular and/or Intra
      Articular scapula fracture meeting inclusion criteria will be asked for their signed consent
      to participate in the outcomes registry regardless of treatment plan (operative or
      non-operative).

      Justification for stated number of subjects:

      The goal of this study is to capture as many patients meeting inclusion criteria from the
      enrolling sites as possible. The investigators estimate this to be between 10 and 13 patients
      per site, per year.

      Participating sites: Participating sites will be identified based on their experience and
      expertise in scapula repair, their interest in research, and their desire to advance
      knowledge and continuing education in this area. Initially, Dr. Peter Cole will personally
      invite new sites. Future site recruitment will be approved by Dr. Peter Cole and a selected
      board. Sites must have the necessary research infrastructure and be willing and able to
      follow all rules and regulations associated with Human Research requirements. They will be
      required to submit evidence of site IRB approval prior to initiation.

      Data Collection:

      Time point: Day 0

      Activity: obtain patient consent, x-rays, chart review, data pull from electronic medical
      record

      Activity conducted by: study coordinator at participating NASCon site

      Time point: 6 wks , 3 mos, 6 mos, 12 mos, 24 mos

      Activity: patient questionnaires, Range of Motion, Strength, and x-rays

      The following is a list of demographic and treatment variables that will be collected during
      the patient's initial enrollment visit as well as from the patient's EMR:

      Demographics: Gender, date of birth, dominant hand

      Injury: Inclusion indication, radiographic image, date of injury, mechanism of injury, side
      of scapular injury, ipsilateral UE fractures, other SSSC lesions, other system injuries, Ada
      & AO/OTA Classifications, prior treatment, and workman's compensation status.

      Surgical Data (when applicable): Date of surgery, operative time, estimated blood loss, other
      procedures, subsequent shoulder procedures required, scapula operative approach, type of
      implant.

      The following is a list of outcome variables that will be collected during each follow-up
      clinic visit as well as from the patient's EMR:

      General Information: Physical Therapy, activity level, return to work, pain/pain medication,
      complications, subsequent procedures, radiographic image.

      Range of Motion:

      A 14 inch goniometer will be used to evaluate flexion, abduction, external rotation, internal
      rotation on injured and contralateral shoulder.

      Strength:

      A handheld dynamometer (MicroFET 2, Hoggan Health Industries, Draper, Utah), which has been
      previously published as a reliable technique10, will assess strength in shoulder flexion,
      abduction, and external rotation on injured and contralateral shoulder.

      Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH). 11

      The DASH was developed to measure physical disability and symptoms of the upper extremities
      in people with upper extremity disorders (hand, wrist, elbow, and shoulder). It is a 30-item
      scale that addresses difficulty in performing various physical activities that require upper
      extremity function, stiffness, and impact of disability and symptoms on social activities,
      work, sleep, and psychological well-being. The score ranges from 0 to 100, where 0 is
      equivalent to no disability and 100 is equivalent to most severe disability. The DASH is a
      validated instrument with established normative and minimal clinically important difference.

      SF-12v2

      The SF-12v2 is a multipurpose, short-form health survey with 12 questions. The SF-12v2 was
      developed in 1994 by The Health Institute as a shortened version of the SF-36 health survey.
      It yields an eight-scale profile of scores as well as physical and mental health summary
      measures. The eight scales include: physical functioning, role of physical functioning,
      mental functioning, role of mental functioning, social function, bodily pain, vitality, and
      general health. It is a generic measure, as opposed to one that targets a specific age,
      disease, or treatment group.

      Reporting of Results:

      Demographic data, treatment details, and outcome variables will be summarized through
      frequencies and proportions, if they are categorical, or through measures of central tendency
      (e.g., mean, median) and dispersion (e.g. standard deviation, quartiles) if they are
      continuous. Quarterly registry reporting will include enrollment rates, follow-up capture
      rates, descriptive summaries of demographic, surgical and outcomes data as well as a
      description of any safety events for which the membership or the sponsors should be made
      aware. Reports will be shared with the membership and study sponsors on a minimum of an
      annual basis.

      Publication and presentation of outcomes is expected in peer-reviewed orthopaedic journals
      and symposia, once substantial data collection and outcomes of ≥1 year post-injury are
      accomplished. Additionally, opportunities to describe the establishment of an injury specific
      consortium and registry, including experience, process and tools utilized in the development
      of such a registry, may be pursued by the membership.
observational model: Cohort
time perspective: Prospective
measure: Data Submission measured by total number of participating sites and patient enrollment
time frame: Three years
description: Anticipated:
Year 1 - 10 Sites,80 Subjects Enrolled Year 2 - 13 Sites, 130 Subjects Enrolled Year 3 - 16 Sites, 170 Subjects Enrolled
measure: Optimization of data submission and data collected by statistician review of exported data collection
time frame: Biannual review (June 2017, Dec 2017, June 2018, Dec 2018, June 2019, Dec 2019-end date)
description: A qualified statistician will review all data submitted biannually and determine the percent of unpopulated fields and provide strategy for optimizing data collection. Sites will be notified of missing data and strongly encourages to complete.
arm group label: Operative Scapula Fracture
description: No intervention. Inclusion criteria and data collection is the same for both cohort.
arm group label: Non-Operative Scapula Fracture
description: No intervention. Inclusion criteria and data collection is the same for both cohort.
intervention type: Other
intervention name: No intervention
arm group label: Non-Operative Scapula Fracture
arm group label: Operative Scapula Fracture
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter A Cole, MD
role: Principal Investigator
affiliation: University of Minnesota
responsible party type: Principal Investigator
investigator affiliation: University of Minnesota
investigator full name: Peter A Cole, MD
investigator title: Chair, Orthopaedic Dept., Regions Hospital; Professor, University of Minnesota
mesh term: Fractures, Bone
sharing ipd: No