<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/NCT04474665</url>
  </required_header>
  <id_info>
    <org_study_id>Blueprint-2019</org_study_id>
    <nct_id>NCT04474665</nct_id>
  </id_info>
  <brief_title>Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty</brief_title>
  <official_title>A Single-arm, Prospective Study of Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spine Institute of Louisiana Foundation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker Trauma GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Spine Institute of Louisiana Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to&#xD;
      operative implant size selected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Blueprint planning software automatically creates a virtual implantation environment for&#xD;
      the surgeon to use. The use of 3D measurements is independent of patient positioning, which&#xD;
      results in more accurate measurements of the glenoid version and inclination measurements in&#xD;
      shoulder replacement surgery.&#xD;
&#xD;
      Pre-operative planning with Blueprint can accurately predict intraoperative implant selection&#xD;
      within one size. Also, pre-operative planning leads to case efficiency and improved&#xD;
      functional outcomes at 6 months post-operative compared to Baseline.&#xD;
&#xD;
      The objective of this study is to characterize implant size accuracy, planning time,&#xD;
      functional outcomes, and procedural time (i.e., surgical time) using Blueprint planning&#xD;
      software in subjects who are candidates for reverse shoulder arthroplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">March 16, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Range of motion</measure>
    <time_frame>6 months</time_frame>
    <description>Range of motion of the operative shoulder</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of sizing</measure>
    <time_frame>Perioperative</time_frame>
    <description>Blueprint planned implant size compared to actual implant size</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to plan/perform case</measure>
    <time_frame>Pre-operative</time_frame>
    <description>Time required for surgeon to plan and perform the case using the Bluerpint software</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to plan/perform case</measure>
    <time_frame>Perioperative</time_frame>
    <description>Time required for surgeon to plan and perform the case using the Bluerpint software</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Questionnaire to score and understand how well you function in everyday life, concerning your shoulder pain/limitations. 0-100 score, with higher score indicating higher functionality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire to score and understand how well you function in everyday life, concerning your shoulder pain/limitations. 0-100 score, with higher score indicating higher functionality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Shoulder Test (SST) Questionnaire</measure>
    <time_frame>Pre-operative</time_frame>
    <description>12 yes/no questions to understand your daily functionality concerning your shoulder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Shoulder Test (SST) Questionnaire</measure>
    <time_frame>2 weeks</time_frame>
    <description>12 yes/no questions to understand your daily functionality concerning your shoulder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Shoulder Test (SST) Questionnaire</measure>
    <time_frame>6 weeks</time_frame>
    <description>12 yes/no questions to understand your daily functionality concerning your shoulder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Shoulder Test (SST) Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>12 yes/no questions to understand your daily functionality concerning your shoulder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Shoulder Test (SST) Questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>12 yes/no questions to understand your daily functionality concerning your shoulder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Reverse Shoulder Replacement</condition>
  <arm_group>
    <arm_group_label>Implant placement accuracy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blueprint planning software will be used to plan reverse shoulder replacement surgery. Accuracy of the placement compared to the plan will be assessed post-surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reverse shoulder arthroplasty utilizing Blueprint Software</intervention_name>
    <description>Reverse shoulder arthroplasty utilizing Blueprint Software</description>
    <arm_group_label>Implant placement accuracy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Skeletally mature, and age ≥ 18 years.&#xD;
&#xD;
          2. In the opinion of the treating surgeon, must already be a qualified candidate for&#xD;
             reverse shoulder arthroplasty without the use of glenoid bone grafts.&#xD;
&#xD;
          3. Be likely to return for regular follow-ups until the end of the study period.&#xD;
&#xD;
          4. Be willing and able to provide Informed Consent for study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous bony surgery on the operative shoulder.&#xD;
&#xD;
          2. Shoulder pain due to acute trauma.&#xD;
&#xD;
          3. Clinical, laboratory and/or radiological evidence of shoulder pain secondary to acute&#xD;
             or chronic infection, malignancy, other space occupying lesions and metabolic bone&#xD;
             demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)&#xD;
&#xD;
          4. Any active malignancy, infectious process, or documented chronic autoimmune disease.&#xD;
&#xD;
          5. Any other concurrent medical disease or treatment that might impair normal healing&#xD;
             process.&#xD;
&#xD;
          6. Recent history (within past 6 months) of any chemical or alcohol dependence.&#xD;
&#xD;
          7. Currently a prisoner.&#xD;
&#xD;
          8. Currently experiencing a major mental illness (psychosis, schizophrenia, major&#xD;
             affective disorder) which may indicate that the symptoms are psychological rather than&#xD;
             of physical origin.&#xD;
&#xD;
          9. Pregnant or planning to become pregnant within study duration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Googe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopedics Specialists of Louisiana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spine Institute of Louisiana</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04474665
org study id: Blueprint-2019
nct id: NCT04474665
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to
      operative implant size selected.
The Blueprint planning software automatically creates a virtual implantation environment for
      the surgeon to use. The use of 3D measurements is independent of patient positioning, which
      results in more accurate measurements of the glenoid version and inclination measurements in
      shoulder replacement surgery.

      Pre-operative planning with Blueprint can accurately predict intraoperative implant selection
      within one size. Also, pre-operative planning leads to case efficiency and improved
      functional outcomes at 6 months post-operative compared to Baseline.

      The objective of this study is to characterize implant size accuracy, planning time,
      functional outcomes, and procedural time (i.e., surgical time) using Blueprint planning
      software in subjects who are candidates for reverse shoulder arthroplasty.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Range of motion
time frame: 6 months
description: Range of motion of the operative shoulder
measure: Accuracy of sizing
time frame: Perioperative
description: Blueprint planned implant size compared to actual implant size
measure: Time to plan/perform case
time frame: Pre-operative
description: Time required for surgeon to plan and perform the case using the Bluerpint software
measure: Time to plan/perform case
time frame: Perioperative
description: Time required for surgeon to plan and perform the case using the Bluerpint software
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
time frame: 12 weeks
description: Questionnaire to score and understand how well you function in everyday life, concerning your shoulder pain/limitations. 0-100 score, with higher score indicating higher functionality.
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
time frame: 6 months
description: Questionnaire to score and understand how well you function in everyday life, concerning your shoulder pain/limitations. 0-100 score, with higher score indicating higher functionality.
measure: Simple Shoulder Test (SST) Questionnaire
time frame: Pre-operative
description: 12 yes/no questions to understand your daily functionality concerning your shoulder.
measure: Simple Shoulder Test (SST) Questionnaire
time frame: 2 weeks
description: 12 yes/no questions to understand your daily functionality concerning your shoulder.
measure: Simple Shoulder Test (SST) Questionnaire
time frame: 6 weeks
description: 12 yes/no questions to understand your daily functionality concerning your shoulder.
measure: Simple Shoulder Test (SST) Questionnaire
time frame: 12 weeks
description: 12 yes/no questions to understand your daily functionality concerning your shoulder.
measure: Simple Shoulder Test (SST) Questionnaire
time frame: 6 months
description: 12 yes/no questions to understand your daily functionality concerning your shoulder.
measure: Patient Satisfaction
time frame: 12 weeks
description: Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied
measure: Patient Satisfaction
time frame: 6 months
description: Patient rated satisfaction with surgical treatment rated; very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied
arm group label: Implant placement accuracy
arm group type: Other
description: Blueprint planning software will be used to plan reverse shoulder replacement surgery. Accuracy of the placement compared to the plan will be assessed post-surgery.
intervention type: Device
intervention name: Reverse shoulder arthroplasty utilizing Blueprint Software
description: Reverse shoulder arthroplasty utilizing Blueprint Software
arm group label: Implant placement accuracy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Googe, MD
role: Principal Investigator
affiliation: Orthopedics Specialists of Louisiana
facility: 
country: United States
responsible party type: Sponsor