<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/NCT04468178</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-RSA-Global-Icon-2020</org_study_id>
    <nct_id>NCT04468178</nct_id>
  </id_info>
  <brief_title>Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder</brief_title>
  <official_title>Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hannover Medical School</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>
      The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system&#xD;
      from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from&#xD;
      Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the&#xD;
      implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with&#xD;
      an already established prosthetic system (SIMPLICITY, Wright Medical).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system&#xD;
      from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from&#xD;
      Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the&#xD;
      implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with&#xD;
      an already established prosthetic system (SIMPLICITY, Wright Medical).&#xD;
&#xD;
      As secondary endpoints, the migration behavior of the humeral components over time will be&#xD;
      determined by radiostereometric analysis (RSA), the further clinical-functional results and&#xD;
      the satisfaction of the patients treated will be investigated. Clinical outcomes are measured&#xD;
      using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short&#xD;
      Form Health 36-SF-36 v1.0 ) at each time of examination.&#xD;
&#xD;
      Other endpoints include revision rate within the follow-up period, surgical time (incision to&#xD;
      suture), and delays in surgical procedures due to instrumentation.&#xD;
&#xD;
      The times of data acquisition are the admission day before the operation to determine the&#xD;
      preoperative status, the discharge day and the follow-up appointments after 3 months, 6&#xD;
      months, 12 months and 24 months to determine the postoperative status and course.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 17, 2021</start_date>
  <completion_date type="Anticipated">March 17, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 17, 2024</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>
    <intervention_model_description>prospective, randomized controlled mono-centric study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Constant-Murley Score (CMS)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Constant-Murley Score (CMS)</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Constant-Murley Score (CMS)</measure>
    <time_frame>24 months postoperative</time_frame>
    <description>The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxford Shoulder Score (OSS)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Shoulder Score (OSS)</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Shoulder Score (OSS)</measure>
    <time_frame>24 months postoperative</time_frame>
    <description>The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health 36 (SF-36)</measure>
    <time_frame>3 months postoperative</time_frame>
    <description>The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health 36 (SF-36)</measure>
    <time_frame>12 months postoperative</time_frame>
    <description>The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health 36 (SF-36)</measure>
    <time_frame>24 months postoperative</time_frame>
    <description>The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Osteoarthritis of the Shoulder</condition>
  <arm_group>
    <arm_group_label>Shoulder prosthesis system GLOBAL ICON from DePuy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The GLOBAL ICON stemless is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIMPLICITY shoulder prosthesis system from Wright Medical</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The SIMPLICITY is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total joint arthroplasty of the glenohumeral joint</intervention_name>
    <description>The arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis.</description>
    <arm_group_label>SIMPLICITY shoulder prosthesis system from Wright Medical</arm_group_label>
    <arm_group_label>Shoulder prosthesis system GLOBAL ICON from DePuy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Trial participants need primary total shoulder replacement due to primary&#xD;
             osteoarthritis or post-traumatic osteoarthritis&#xD;
&#xD;
          2. Trial participants are willing to take part in the clinical trial and intend to be&#xD;
             available for the planned follow-up examinations.&#xD;
&#xD;
          3. Male, female and various subjects with age on the day of surgery from 18 to 80 years&#xD;
             inclusive.&#xD;
&#xD;
          4. Subjects agree not to participate in any other clinical trial for at least 2 years (+&#xD;
             3 weeks) using the index procedure. This includes clinical trials of medication,&#xD;
             invasive procedures and medical devices. Questionnaire-based studies or other studies&#xD;
             that are non-invasive and do not involve drug use are allowed.&#xD;
&#xD;
          5. Exclusion of intraoperative circumstances that require the implantation of a&#xD;
             prosthesis type other than that provided for in the clinical trial (depending on the&#xD;
             surgeon).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous operation on the rotator cuff of the affected shoulder&#xD;
&#xD;
          2. Dysfunctional rotator cuff&#xD;
&#xD;
          3. Infection of the affected shoulder joint or systemic infection&#xD;
&#xD;
          4. Pregnant or breastfeeding women and those who are planning to become pregnant for up&#xD;
             to 2 years (+3 weeks) using the index procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomas Smith, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tomas Smith, PD Dr.</last_name>
    <phone>+49 511 5354 310</phone>
    <email>tomas.smith@diakovere.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift</name>
      <address>
        <city>Hanover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tomas Smith, PD Dr.</last_name>
      <phone>+49 511 5354</phone>
      <phone_ext>310</phone_ext>
      <email>tomas.smith@diakovere.de</email>
    </contact>
    <investigator>
      <last_name>Tomas Smith, PD Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>shoulder</keyword>
  <keyword>joint replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT04468178
org study id: IIT-RSA-Global-Icon-2020
nct id: NCT04468178
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system
      from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from
      Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the
      implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with
      an already established prosthetic system (SIMPLICITY, Wright Medical).
The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system
      from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from
      Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the
      implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with
      an already established prosthetic system (SIMPLICITY, Wright Medical).

      As secondary endpoints, the migration behavior of the humeral components over time will be
      determined by radiostereometric analysis (RSA), the further clinical-functional results and
      the satisfaction of the patients treated will be investigated. Clinical outcomes are measured
      using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short
      Form Health 36-SF-36 v1.0 ) at each time of examination.

      Other endpoints include revision rate within the follow-up period, surgical time (incision to
      suture), and delays in surgical procedures due to instrumentation.

      The times of data acquisition are the admission day before the operation to determine the
      preoperative status, the discharge day and the follow-up appointments after 3 months, 6
      months, 12 months and 24 months to determine the postoperative status and course.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized controlled mono-centric study
primary purpose: Treatment
masking: None (Open Label)
measure: Constant-Murley Score (CMS)
time frame: 3 months postoperative
description: The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
measure: Constant-Murley Score (CMS)
time frame: 12 months postoperative
description: The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
measure: Constant-Murley Score (CMS)
time frame: 24 months postoperative
description: The CMS covers different aspects of shoulder pathology: pain, activities of daily living, range of motion and strength. The possible maximum total score is 100 points (best function). Pain and activities of daily living are answered by the patient; range of motion and strength are answered by the orthopaedic surgeon.
measure: Oxford Shoulder Score (OSS)
time frame: 3 months postoperative
description: The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
measure: Oxford Shoulder Score (OSS)
time frame: 12 months postoperative
description: The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
measure: Oxford Shoulder Score (OSS)
time frame: 24 months postoperative
description: The Oxford Shoulder Score (OSS) is a 12-item patient-reported questionnaire specifically designed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Scores from each question are added so the overall score ranges from 12 to 60 with 12 being the best out-come.
measure: Short Form Health 36 (SF-36)
time frame: 3 months postoperative
description: The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
measure: Short Form Health 36 (SF-36)
time frame: 12 months postoperative
description: The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
measure: Short Form Health 36 (SF-36)
time frame: 24 months postoperative
description: The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health consisting of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
arm group label: Shoulder prosthesis system GLOBAL ICON from DePuy
arm group type: Experimental
description: The GLOBAL ICON stemless is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.
arm group label: SIMPLICITY shoulder prosthesis system from Wright Medical
arm group type: Active Comparator
description: The SIMPLICITY is a shaftless shoulder prosthesis system for anatomical reconstruction of the shoulder joint in cases of total or hemiarthroplasty in the shoulder. The base plate consists of titanium coated with hydroxyapatite, the head of cobalt-chrome.
intervention type: Device
intervention name: Total joint arthroplasty of the glenohumeral joint
description: The arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis.
arm group label: SIMPLICITY shoulder prosthesis system from Wright Medical
arm group label: Shoulder prosthesis system GLOBAL ICON from DePuy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tomas Smith, PD Dr.
role: Principal Investigator
affiliation: Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
last name: Tomas Smith, PD Dr.
phone: +49 511 5354 310
email: tomas.smith@diakovere.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Osteoarthritis