<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/NCT03839758</url>
  </required_header>
  <id_info>
    <org_study_id>PITSA</org_study_id>
    <nct_id>NCT03839758</nct_id>
  </id_info>
  <brief_title>Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study</brief_title>
  <acronym>PITSA</acronym>
  <official_title>Multicenter Randomised Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université de Montréal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total shoulder arthroplasty is an effective procedure to improve patients function and to&#xD;
      relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this&#xD;
      procedure is implanting the glenoid component. Indeed, surgical exposure is difficult and&#xD;
      proper visualization of the glenoid is demanding. The current free-hand method is not precise&#xD;
      and especially unreliable in glenoids with severe deformity. Inappropriate reaming and&#xD;
      glenoid positioning can cause more bone loss during surgery.&#xD;
&#xD;
      In anatomic prostheses, glenoid component fixation is demanding and is the first component to&#xD;
      present loosening at long term follow-up. When it comes to reverse arthroplasty, the glenoid&#xD;
      component, once again, requires the most attention. Malpositioning of the glenosphere can&#xD;
      cause notching, loosening, and instability.&#xD;
&#xD;
      In order to prevent these complications, precision in glenoid implantation is key. To this&#xD;
      end, intraoperative computer navigation would be a helpful tool, but the increased expenses&#xD;
      in computer equipment represent massive costs and possibly increases in surgical time. A more&#xD;
      affordable option is a personalized guide, for which the only extra expense is the customized&#xD;
      guide. These guides are based on precise 3D CT scan templates. Previous studies have&#xD;
      evaluated the precision of the guide in vivo and in vitro, but none have measured it in a&#xD;
      randomized study. As it represents additional costs, its efficacy needs to be proven before&#xD;
      widespread use.&#xD;
&#xD;
      This method may also provide secondary benefits, such as decreasing operating time, lowering&#xD;
      short- and long-term complications, and improving efficacy.&#xD;
&#xD;
      The objective of this study is to evaluate the performance of a patient specific glenoid&#xD;
      guide.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants scheduled for elective primary total shoulder arthroplasty will be contacted&#xD;
      by a research assistant. Preoperative status will be characterized by demographic data, range&#xD;
      of motion, quality of life, and functional status. A CT Scan and x-rays are part of standard&#xD;
      preoperative care and always done prior to total shoulder replacement in our institution;&#xD;
      these images will be collected for the study. Patients will be randomized to one of the two&#xD;
      groups:&#xD;
&#xD;
        1. Patient-specific glenoid guide group: Glenoid preparation will be done using the&#xD;
           personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan&#xD;
           measurement, using Blueprint software prior to surgery.&#xD;
&#xD;
        2. Classic method group: Glenoid preparation will be done following surgeon evaluation of&#xD;
           the 2D CT scan with the institution software. Generic guides included in the regular&#xD;
           instrumentation set will be used.&#xD;
&#xD;
      The investigators will use the classification proposed by Iannotti et al. to characterize&#xD;
      glenoid bone loss prior to surgery. Glenoid bone density will be measured using radiology&#xD;
      software (Hounsfield units). Blueprint software will be used to measure the preoperative&#xD;
      anatomical characteristics of the glenoid: surface area, version, inclination and&#xD;
      subluxation. This will be done prior to surgery in the patient specific group and after&#xD;
      surgery in the classic group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 8, 2019</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The evaluator who will perform the follow-up clinical examination will also be blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Radiological evaluation 1</measure>
    <time_frame>2 weeks post-op</time_frame>
    <description>Comparing the precision of the glenoid implantation during the surgery between both group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiological evaluation 2</measure>
    <time_frame>2 years</time_frame>
    <description>Comparaison of the glenoid fixation durong the surgery, between both group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glenoid bone loss</measure>
    <time_frame>At surgery</time_frame>
    <description>Comparaison of the glenoid bone loss between both group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical time</measure>
    <time_frame>At surgery</time_frame>
    <description>Comparaison og the surgery time between both group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood test</measure>
    <time_frame>Before surgery</time_frame>
    <description>Evaluation of the glenoid quality with nutritional status</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Shoulder Arthritis</condition>
  <arm_group>
    <arm_group_label>TSA Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RTSA standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TSA blueprint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RTSA blueprint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TSA standard</intervention_name>
    <description>Glenoid preparation will be done with 2D CT-Scan</description>
    <arm_group_label>TSA Standard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RTSA standard</intervention_name>
    <description>Glenoid preparation will be done with 2D CT-Scan</description>
    <arm_group_label>RTSA standard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TSA Blueprint</intervention_name>
    <description>Glenoid preparation will be done with Blueprint software</description>
    <arm_group_label>TSA blueprint</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RTSA Blueprint</intervention_name>
    <description>Glenoid preparation will be done with 2D CT-Scan</description>
    <arm_group_label>RTSA blueprint</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with shoulder osteaoarthritis and AVN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous shoulder arthroplasty&#xD;
&#xD;
          -  Patients with inflammatory arthritis and tumor&#xD;
&#xD;
          -  Patients with previous shoulder surgery with metal implant&#xD;
&#xD;
          -  Patients refusing 2-year follow-up&#xD;
&#xD;
          -  Patients that does not speak English or French&#xD;
&#xD;
          -  Patients with current or previous shoulder infection&#xD;
&#xD;
          -  Patients with graft during surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique Rouleau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique Rouleau, MD</last_name>
    <phone>514-338-2222</phone>
    <phone_ext>2050</phone_ext>
    <email>dominique_rouleau@yahoo.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karine Tardif</last_name>
    <phone>514-338-2222</phone>
    <phone_ext>3464</phone_ext>
    <email>karinetardif2@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital du Sacré-Cœur de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique Rouleau</last_name>
      <phone>514-338-2222</phone>
      <phone_ext>2050</phone_ext>
      <email>dominique_rouleau@yahoo.ca</email>
    </contact>
    <contact_backup>
      <last_name>Karine Tardif</last_name>
      <phone>514-338-2222</phone>
      <phone_ext>3465</phone_ext>
      <email>karinetardif2@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Montréal</investigator_affiliation>
    <investigator_full_name>Dominique Rouleau</investigator_full_name>
    <investigator_title>Orthopaedic surgeon</investigator_title>
  </responsible_party>
  <keyword>Prothesis</keyword>
  <keyword>Glenoid implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</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/NCT03839758
org study id: PITSA
nct id: NCT03839758
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Total shoulder arthroplasty is an effective procedure to improve patients function and to
      relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this
      procedure is implanting the glenoid component. Indeed, surgical exposure is difficult and
      proper visualization of the glenoid is demanding. The current free-hand method is not precise
      and especially unreliable in glenoids with severe deformity. Inappropriate reaming and
      glenoid positioning can cause more bone loss during surgery.

      In anatomic prostheses, glenoid component fixation is demanding and is the first component to
      present loosening at long term follow-up. When it comes to reverse arthroplasty, the glenoid
      component, once again, requires the most attention. Malpositioning of the glenosphere can
      cause notching, loosening, and instability.

      In order to prevent these complications, precision in glenoid implantation is key. To this
      end, intraoperative computer navigation would be a helpful tool, but the increased expenses
      in computer equipment represent massive costs and possibly increases in surgical time. A more
      affordable option is a personalized guide, for which the only extra expense is the customized
      guide. These guides are based on precise 3D CT scan templates. Previous studies have
      evaluated the precision of the guide in vivo and in vitro, but none have measured it in a
      randomized study. As it represents additional costs, its efficacy needs to be proven before
      widespread use.

      This method may also provide secondary benefits, such as decreasing operating time, lowering
      short- and long-term complications, and improving efficacy.

      The objective of this study is to evaluate the performance of a patient specific glenoid
      guide.
All participants scheduled for elective primary total shoulder arthroplasty will be contacted
      by a research assistant. Preoperative status will be characterized by demographic data, range
      of motion, quality of life, and functional status. A CT Scan and x-rays are part of standard
      preoperative care and always done prior to total shoulder replacement in our institution;
      these images will be collected for the study. Patients will be randomized to one of the two
      groups:

        1. Patient-specific glenoid guide group: Glenoid preparation will be done using the
           personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan
           measurement, using Blueprint software prior to surgery.

        2. Classic method group: Glenoid preparation will be done following surgeon evaluation of
           the 2D CT scan with the institution software. Generic guides included in the regular
           instrumentation set will be used.

      The investigators will use the classification proposed by Iannotti et al. to characterize
      glenoid bone loss prior to surgery. Glenoid bone density will be measured using radiology
      software (Hounsfield units). Blueprint software will be used to measure the preoperative
      anatomical characteristics of the glenoid: surface area, version, inclination and
      subluxation. This will be done prior to surgery in the patient specific group and after
      surgery in the classic group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The evaluator who will perform the follow-up clinical examination will also be blind
measure: Radiological evaluation 1
time frame: 2 weeks post-op
description: Comparing the precision of the glenoid implantation during the surgery between both group
measure: Radiological evaluation 2
time frame: 2 years
description: Comparaison of the glenoid fixation durong the surgery, between both group
measure: Glenoid bone loss
time frame: At surgery
description: Comparaison of the glenoid bone loss between both group
measure: Surgical time
time frame: At surgery
description: Comparaison og the surgery time between both group
measure: Blood test
time frame: Before surgery
description: Evaluation of the glenoid quality with nutritional status
arm group label: TSA Standard
arm group type: Active Comparator
description: This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used
arm group label: RTSA standard
arm group type: Active Comparator
description: This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done following surgeon evaluation of the 2D CT scan with the institution software. Generic guides included in the regular instrumentation set will be used
arm group label: TSA blueprint
arm group type: Experimental
description: This group will include patients schedule for a total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.
arm group label: RTSA blueprint
arm group type: Experimental
description: This group will include patients schedule for a reverse total shoulder arthroplasty. Glenoid preparation will be done using the personalized guide provided by Wright-Tornier. This guide will be ordered after CT-scan measurement, using Blueprint software prior to surgery.
intervention type: Procedure
intervention name: TSA standard
description: Glenoid preparation will be done with 2D CT-Scan
arm group label: TSA Standard
intervention type: Procedure
intervention name: RTSA standard
description: Glenoid preparation will be done with 2D CT-Scan
arm group label: RTSA standard
intervention type: Procedure
intervention name: TSA Blueprint
description: Glenoid preparation will be done with Blueprint software
arm group label: TSA blueprint
intervention type: Procedure
intervention name: RTSA Blueprint
description: Glenoid preparation will be done with 2D CT-Scan
arm group label: RTSA blueprint
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Dominique Rouleau, MD
role: Principal Investigator
affiliation: Université de Montréal
last name: Dominique Rouleau, MD
phone: 514-338-2222
phone ext: 2050
email: dominique_rouleau@yahoo.ca
last name: Karine Tardif
phone: 514-338-2222
phone ext: 3464
email: karinetardif2@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Montréal
investigator full name: Dominique Rouleau
investigator title: Orthopaedic surgeon
mesh term: Arthritis