<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/NCT02966886</url>
  </required_header>
  <id_info>
    <org_study_id>20160779-01H</org_study_id>
    <nct_id>NCT02966886</nct_id>
  </id_info>
  <brief_title>TSA Techniques in Glenohumeral OA</brief_title>
  <official_title>Comparison of Shoulder Arthroplasty Techniques in the Treatment of Glenohumeral Osteoarthritis: Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage&#xD;
      over time. OA can produce pain and dysfunction at the affected joint and is a growing&#xD;
      occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment&#xD;
      used to treat patients with shoulder OA which involves replacing the worn-out ball and socket&#xD;
      shoulder joint with prosthetic components. TSA is performed today with high success rates,&#xD;
      however, complication rates associated with TSA remain prevalent particularly when the&#xD;
      arthritis is associated with bone erosion on the glenoid (socket).&#xD;
&#xD;
      Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone&#xD;
      erosion, a number of surgical strategies have been developed. These surgical techniques&#xD;
      include eccentric reaming which involves removing bone from the front of the socket,&#xD;
      augmented glenoid component implantation, and posterior bone grafting to compensate for&#xD;
      glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared&#xD;
      these different surgical techniques to one another. Previous studies have been limited to&#xD;
      case series with small sample sizes and respective designs. This study is being conducted to&#xD;
      determine which approach produces better outcomes. For the purpose of this study we will be&#xD;
      comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric&#xD;
      reaming and b) augmented glenoid component and bone grafting in participants with advanced&#xD;
      glenohumeral osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who have 10-15 degrees of retroversion will be randomly assigned to one of two&#xD;
      standard of care treatment groups: TSA with eccentric glenoid reaming or TSA with augmented&#xD;
      glenoid component implantation.&#xD;
&#xD;
      Patients whose condition involves &gt; 15 degrees of retroversion will be randomly assigned to&#xD;
      one of two standard of care treatment groups: TSA with augmented glenoid component&#xD;
      implantation or posterior glenoid bone grafting.&#xD;
&#xD;
      The primary objective will be measured by the Western Ontario Osteoarthritis of the Shoulder&#xD;
      Index (WOOS) score pre-operatively and at post-operative time intervals (i.e. 3, 6, 12 and 24&#xD;
      months).&#xD;
&#xD;
      Secondary Objectives: i) To determine the survivorship of the components as measured by the&#xD;
      degree of radiographic lucencies and component alignment determined by a CT scan at 1 and 5&#xD;
      years post-surgery between study arms in both age groups.&#xD;
&#xD;
      ii) To determine the difference in disease specific quality of life between treatment&#xD;
      allocations in both age groups as measured by the Constant score, the American Shoulder and&#xD;
      Elbow Surgeons Standardized Shoulder Assessment form (ASES) and the EuroQol Group EQ-5D-5L&#xD;
      score pre-operatively and at post-operative time intervals (i.e. 3, 6, 12 and 24 months), as&#xD;
      well as adverse events, and health care utilization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 23, 2017</start_date>
  <completion_date type="Anticipated">December 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2027</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>
  </study_design_info>
  <primary_outcome>
    <measure>Western Ontario Osteoarthritis of the Shoulder Index (WOOS)</measure>
    <time_frame>24-Months</time_frame>
    <description>The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Ontario Osteoarthritis of the Shoulder Index (WOOS)</measure>
    <time_frame>5-Years Post-Operative</time_frame>
    <description>The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)</measure>
    <time_frame>24-Months Post-Operative</time_frame>
    <description>The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)</measure>
    <time_frame>5-Years Post-Operative</time_frame>
    <description>The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol EQ-5D-5L</measure>
    <time_frame>24-Months Post-Operative</time_frame>
    <description>The EuroQol EQ-5D-5L quality of life questionnaire is a brief, easy to administer generic health status questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression. It also includes a visual analogue scale for recording an individual's rating of their current health-related quality of life (scale 0 to 100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol EQ-5D-5L</measure>
    <time_frame>5-Years Post-Operative</time_frame>
    <description>The EuroQol EQ-5D-5L quality of life questionnaire is a brief, easy to administer generic health status questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression. It also includes a visual analogue scale for recording an individual's rating of their current health-related quality of life (scale 0 to 100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constant Score</measure>
    <time_frame>24-Months Post-Operative</time_frame>
    <description>The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constant Score</measure>
    <time_frame>5-Years Post-Operative</time_frame>
    <description>The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder Health Utilization</measure>
    <time_frame>5-Years Post-Operative</time_frame>
    <description>Health care utilization will be monitored and recorded using a questionnaire. These questions will include healthcare the patient accessed, cost of care, and medications taken during treatment. From this information, a cost-effectiveness analysis will be completed, which will adhere to the best practices for conducting and reporting of health economic evaluations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AE) and Serious Adverse Events (SAE)</measure>
    <time_frame>5-Years Post-Operative</time_frame>
    <description>Rates of study adverse events or serious adverse events (e.g. number of reoperations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">216</enrollment>
  <condition>Osteoarthritis, Shoulder</condition>
  <arm_group>
    <arm_group_label>Participants with 10-15 degrees of glenoid retroversion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants with &gt;15 degrees of glenoid retroversion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Eccentric Reaming</intervention_name>
    <description>Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric (&quot;high side&quot;) anterior reaming to within &lt; 10 degrees of neutral glenoid version.</description>
    <arm_group_label>Participants with 10-15 degrees of glenoid retroversion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Augmented Glenoid Component Implantation</intervention_name>
    <description>Patients will undergo standard glenoid preparation and implantation of a posteriorly augmented glenoid component. The degree of posterior augment will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.</description>
    <arm_group_label>Participants with 10-15 degrees of glenoid retroversion</arm_group_label>
    <arm_group_label>Participants with &gt;15 degrees of glenoid retroversion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Posterior Glenoid Bone Grafting</intervention_name>
    <description>Patient will undergo a total shoulder arthroplasty as per standard technique. Glenoid version will be restored to within 10 degrees of neutral with a posterior glenoid bone graft. The bone graft will be harvested from the humeral head and fixed to the posterior glenoid with mini-fragment screws.</description>
    <arm_group_label>Participants with &gt;15 degrees of glenoid retroversion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Population The target population is both men and women of any age with advanced&#xD;
        osteoarthritis of the glenohumeral joint who are considered by the treating surgeon to be a&#xD;
        candidate for shoulder replacement. The type of arthritic process will not be considered a&#xD;
        deciding factor. The arthritis must be amenable to treatment using either a humeral head&#xD;
        replacement (stemmed or stem-less), or a standard total shoulder replacement.&#xD;
&#xD;
        Inclusion Criteria&#xD;
&#xD;
          1. Patients who have failed standard non-surgical management of their shoulder&#xD;
             osteoarthritis who would benefit from a shoulder arthroplasty. Failed medical&#xD;
             management will be defined as persistent pain and disability despite adequate standard&#xD;
             non-operative management for 6 months. Medical management will be defined as:&#xD;
&#xD;
               1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs&#xD;
&#xD;
               2. Physiotherapy consisting of stretching, strengthening and local modalities&#xD;
                  (ultrasound, cryotherapy, etc.)&#xD;
&#xD;
               3. Activity modification&#xD;
&#xD;
          2. Patients will present with a glenoid retroversion between 10-26 degrees.&#xD;
&#xD;
          3. Imaging, and intra-operative findings confirming advanced humeral head cartilage loss,&#xD;
             with or without glenoid cartilage loss.&#xD;
&#xD;
          4. Age 18 years or older&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. &lt; 10 degrees / &gt; 27 degrees of glenoid retroversion&#xD;
&#xD;
          2. Active joint or systemic infection&#xD;
&#xD;
          3. Rotator cuff arthropathy&#xD;
&#xD;
          4. Significant muscle paralysis&#xD;
&#xD;
          5. Charcot's arthropathy&#xD;
&#xD;
          6. Major medical illness (life expectancy less than 1 year or unacceptably high operative&#xD;
             risk)&#xD;
&#xD;
          7. Unable to understand the consent form/process&#xD;
&#xD;
          8. Pregnancy&#xD;
&#xD;
          9. Psychiatric illness that precludes informed consent&#xD;
&#xD;
         10. Unwilling to be followed for the duration of the study&#xD;
&#xD;
         11. Retroversion cannot be surgically corrected to within 10 degrees of neutral&#xD;
&#xD;
         12. History of previous shoulder surgery on affected side&#xD;
&#xD;
         13. Rheumatoid arthritis in the affected shoulder&#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 Lapner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Lapner, MD</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>78377</phone_ext>
    <email>plapner@toh.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katie McIlquham</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>79839</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Lapner, MD</last_name>
      <phone>6137378899</phone>
      <phone_ext>78377</phone_ext>
      <email>plapner@toh.on.ca</email>
    </contact>
    <investigator>
      <last_name>Peter Lapner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>J W Pollock, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgical Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02966886
org study id: 20160779-01H
nct id: NCT02966886
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage
      over time. OA can produce pain and dysfunction at the affected joint and is a growing
      occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment
      used to treat patients with shoulder OA which involves replacing the worn-out ball and socket
      shoulder joint with prosthetic components. TSA is performed today with high success rates,
      however, complication rates associated with TSA remain prevalent particularly when the
      arthritis is associated with bone erosion on the glenoid (socket).

      Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone
      erosion, a number of surgical strategies have been developed. These surgical techniques
      include eccentric reaming which involves removing bone from the front of the socket,
      augmented glenoid component implantation, and posterior bone grafting to compensate for
      glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared
      these different surgical techniques to one another. Previous studies have been limited to
      case series with small sample sizes and respective designs. This study is being conducted to
      determine which approach produces better outcomes. For the purpose of this study we will be
      comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric
      reaming and b) augmented glenoid component and bone grafting in participants with advanced
      glenohumeral osteoarthritis.
Patients who have 10-15 degrees of retroversion will be randomly assigned to one of two
      standard of care treatment groups: TSA with eccentric glenoid reaming or TSA with augmented
      glenoid component implantation.

      Patients whose condition involves > 15 degrees of retroversion will be randomly assigned to
      one of two standard of care treatment groups: TSA with augmented glenoid component
      implantation or posterior glenoid bone grafting.

      The primary objective will be measured by the Western Ontario Osteoarthritis of the Shoulder
      Index (WOOS) score pre-operatively and at post-operative time intervals (i.e. 3, 6, 12 and 24
      months).

      Secondary Objectives: i) To determine the survivorship of the components as measured by the
      degree of radiographic lucencies and component alignment determined by a CT scan at 1 and 5
      years post-surgery between study arms in both age groups.

      ii) To determine the difference in disease specific quality of life between treatment
      allocations in both age groups as measured by the Constant score, the American Shoulder and
      Elbow Surgeons Standardized Shoulder Assessment form (ASES) and the EuroQol Group EQ-5D-5L
      score pre-operatively and at post-operative time intervals (i.e. 3, 6, 12 and 24 months), as
      well as adverse events, and health care utilization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
time frame: 24-Months
description: The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
measure: Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
time frame: 5-Years Post-Operative
description: The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
time frame: 24-Months Post-Operative
description: The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
time frame: 5-Years Post-Operative
description: The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
measure: EuroQol EQ-5D-5L
time frame: 24-Months Post-Operative
description: The EuroQol EQ-5D-5L quality of life questionnaire is a brief, easy to administer generic health status questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression. It also includes a visual analogue scale for recording an individual's rating of their current health-related quality of life (scale 0 to 100).
measure: EuroQol EQ-5D-5L
time frame: 5-Years Post-Operative
description: The EuroQol EQ-5D-5L quality of life questionnaire is a brief, easy to administer generic health status questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression. It also includes a visual analogue scale for recording an individual's rating of their current health-related quality of life (scale 0 to 100).
measure: Constant Score
time frame: 24-Months Post-Operative
description: The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
measure: Constant Score
time frame: 5-Years Post-Operative
description: The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
measure: Shoulder Health Utilization
time frame: 5-Years Post-Operative
description: Health care utilization will be monitored and recorded using a questionnaire. These questions will include healthcare the patient accessed, cost of care, and medications taken during treatment. From this information, a cost-effectiveness analysis will be completed, which will adhere to the best practices for conducting and reporting of health economic evaluations.
measure: Adverse Events (AE) and Serious Adverse Events (SAE)
time frame: 5-Years Post-Operative
description: Rates of study adverse events or serious adverse events (e.g. number of reoperations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.
arm group label: Participants with 10-15 degrees of glenoid retroversion
arm group type: Active Comparator
arm group label: Participants with >15 degrees of glenoid retroversion
arm group type: Active Comparator
intervention type: Procedure
intervention name: Eccentric Reaming
description: Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within < 10 degrees of neutral glenoid version.
arm group label: Participants with 10-15 degrees of glenoid retroversion
intervention type: Procedure
intervention name: Augmented Glenoid Component Implantation
description: Patients will undergo standard glenoid preparation and implantation of a posteriorly augmented glenoid component. The degree of posterior augment will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.
arm group label: Participants with 10-15 degrees of glenoid retroversion
arm group label: Participants with >15 degrees of glenoid retroversion
intervention type: Procedure
intervention name: Posterior Glenoid Bone Grafting
description: Patient will undergo a total shoulder arthroplasty as per standard technique. Glenoid version will be restored to within 10 degrees of neutral with a posterior glenoid bone graft. The bone graft will be harvested from the humeral head and fixed to the posterior glenoid with mini-fragment screws.
arm group label: Participants with >15 degrees of glenoid retroversion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Lapner, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
last name: Peter Lapner, MD
phone: 613-737-8899
phone ext: 78377
email: plapner@toh.ca
last name: Katie McIlquham
phone: 613-737-8899
phone ext: 79839
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: Undecided