xml: <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/NCT06032416</url>
    </required_header>
    <id_info>
      <org_study_id>CSG2023-05E</org_study_id>
      <nct_id>NCT06032416</nct_id>
    </id_info>
    <brief_title>DenCT Shoulder Bone Quality Evaluation</brief_title>
    <official_title>Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zimmer Biomet</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Zimmer, GmbH</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Zimmer Biomet</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of the study is to evaluate the preoperative bone quality assessment based on&#xD;
        CT to later establish a scale for the decision of stemless shoulder arthroplasty.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary endpoint is the collection of the preoperative CT scan with a calibration phantom&#xD;
        at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this&#xD;
        study is not centered around a specific device and any primary shoulder arthroplasty system&#xD;
        from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations&#xD;
        can be used for the target population. The indications of this study are the shoulder joint&#xD;
        diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with&#xD;
        TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the&#xD;
        system will be assessed by monitoring the frequency and incidence of adverse events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>CT scan data acquisition</measure>
      <time_frame>Immediate post-op</time_frame>
      <description>The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intra-op bone quality evaluation: Thumb Test</measure>
      <time_frame>Intra-op</time_frame>
      <description>The first test is the Thumb test that occurs just after the head resection. The surgeon presses his/her thumb on the resected humeral surface to assess bone quality. If he can depress the thumb into the humerus without much resistance, then primary stability of the stemless implant may be insufficient.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intra-op bone quality evaluation: Pin Test</measure>
      <time_frame>Intra-op</time_frame>
      <description>The second test is the Pin test where the central pin used to position the trial head is wiggled to assess bone quality. If the central pin is unstable in the humerus, then this may indicate that the bone is soft/weak.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intra-op bone quality evaluation: Broach Test</measure>
      <time_frame>Intra-op</time_frame>
      <description>The third test is the Broach (or Puncher test) where the impactor is wiggled to assess bone quality. If the puncher is unstable after impaction, then the bone is soft/weak, and a stemmed prosthesis is recommended.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duplicate CT scan data acquisition (Optional)</measure>
      <time_frame>Immediate post-op</time_frame>
      <description>Additional primary endpoint for a sub-cohort of a maximum of 30 patients. These patients will receive a second preoperative CT scan after a changing position (patient repositioning), which is needed to evaluate the precision of the phantom-less method. This duplicated scan is considered optional in the study.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Functional Performance (Optional): Constant &amp; Murley Score</measure>
      <time_frame>Pre-op</time_frame>
      <description>The Constant &amp; Murley Score (CMS) is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Osteoarthritis Shoulder</condition>
    <condition>Rotator Cuff Tears</condition>
    <arm_group>
      <arm_group_label>Shoulder Arthroplasty</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients in need of a shoulder arthroplasty</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Preoperative CT Scan</intervention_name>
      <description>Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.</description>
      <arm_group_label>Shoulder Arthroplasty</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient must be older than 18 years and skeletally mature.&#xD;
  &#xD;
            -  Patient must undergo the SHA, TSA, or RSA according to the Instructions for Use (IFU).&#xD;
  &#xD;
            -  Patient must be anatomically and structurally suited to receive shoulder arthroplasty&#xD;
               implants.&#xD;
  &#xD;
            -  Patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or&#xD;
               more of the following:&#xD;
  &#xD;
            -  Non-inflammatory degenerative joint disease including osteoarthritis.&#xD;
  &#xD;
            -  Avascular necrosis of the humeral head.&#xD;
  &#xD;
            -  Autoimmune disease including rheumatoid arthritis.&#xD;
  &#xD;
            -  Irreparable rotator cuff tears.&#xD;
  &#xD;
            -  Correction of functional deformity.&#xD;
  &#xD;
            -  Patient must be able and willing to sign the IRB/EC approved informed consent.&#xD;
  &#xD;
            -  Patient must be able to undergo a preoperative CT scan&#xD;
  &#xD;
            -  Patient must be willing to share their CT images with sponsor&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient is a candidate for shoulder arthroplasty due to one or more of the following:&#xD;
  &#xD;
            -  Fractures of the proximal humerus, where other methods of treatment are deemed&#xD;
               inadequate.&#xD;
  &#xD;
            -  Revision TSA/RSA after the prior TSA/RSA.&#xD;
  &#xD;
            -  Patient has experienced the traumatic fractures to the implant site.&#xD;
  &#xD;
            -  Patient is unwilling or unable to give consent&#xD;
  &#xD;
            -  Patient has any condition which would in the judgement of the Investigator, place the&#xD;
               patient at undue risk or interfere with the study, e.g., any neuromuscular disease&#xD;
               compromising the affected limb.&#xD;
  &#xD;
            -  Patient is known to be pregnant or breastfeeding.&#xD;
  &#xD;
            -  Patient is a vulnerable subject (prisoner, mentally incompetent or unable to&#xD;
               understand what participation to the study entails, a known alcohol or drug abuser,&#xD;
               and/or anticipated to be non- compliant).&#xD;
  &#xD;
            -  Patient is uncooperative or patient with neurologic disorders who is incapable or&#xD;
               unwilling to follow directions.&#xD;
  &#xD;
            -  Patient has any sign of infection affecting the shoulder joint or in its proximity&#xD;
               which may spread to the implant site.&#xD;
  &#xD;
            -  Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on&#xD;
               roentgenogram.&#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>Elliott Goff, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Zimmer, GmbH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elliott Goff, PhD</last_name>
      <phone>41792222308</phone>
      <email>elliott.goff@zimmerbiomet.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ghislain Maquer</last_name>
      <email>ghislain.maquer@zimmerbiomet.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Joint Surgery, Sports Clinic Ishinomaki</name>
        <address>
          <city>Ishinomaki</city>
          <state>Miyagi</state>
          <country>Japan</country>
        </address>
      </facility>
      <contact>
        <last_name>Taku Hatta, PhD</last_name>
        <phone>+81-225-98-9901</phone>
        <email>t-hatta@jss-clinic.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rotator Cuff Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032416
  org study id: CSG2023-05E
  nct id: NCT06032416
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The objective of the study is to evaluate the preoperative bone quality assessment based on
        CT to later establish a scale for the decision of stemless shoulder arthroplasty.
  The primary endpoint is the collection of the preoperative CT scan with a calibration phantom
        at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this
        study is not centered around a specific device and any primary shoulder arthroplasty system
        from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations
        can be used for the target population. The indications of this study are the shoulder joint
        diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with
        TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the
        system will be assessed by monitoring the frequency and incidence of adverse events.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: CT scan data acquisition
  time frame: Immediate post-op
  description: The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality.
  measure: Intra-op bone quality evaluation: Thumb Test
  time frame: Intra-op
  description: The first test is the Thumb test that occurs just after the head resection. The surgeon presses his/her thumb on the resected humeral surface to assess bone quality. If he can depress the thumb into the humerus without much resistance, then primary stability of the stemless implant may be insufficient.
  measure: Intra-op bone quality evaluation: Pin Test
  time frame: Intra-op
  description: The second test is the Pin test where the central pin used to position the trial head is wiggled to assess bone quality. If the central pin is unstable in the humerus, then this may indicate that the bone is soft/weak.
  measure: Intra-op bone quality evaluation: Broach Test
  time frame: Intra-op
  description: The third test is the Broach (or Puncher test) where the impactor is wiggled to assess bone quality. If the puncher is unstable after impaction, then the bone is soft/weak, and a stemmed prosthesis is recommended.
  measure: Duplicate CT scan data acquisition (Optional)
  time frame: Immediate post-op
  description: Additional primary endpoint for a sub-cohort of a maximum of 30 patients. These patients will receive a second preoperative CT scan after a changing position (patient repositioning), which is needed to evaluate the precision of the phantom-less method. This duplicated scan is considered optional in the study.
  measure: Functional Performance (Optional): Constant & Murley Score
  time frame: Pre-op
  description: The Constant & Murley Score (CMS) is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.
  arm group label: Shoulder Arthroplasty
  arm group type: Other
  description: Patients in need of a shoulder arthroplasty
  intervention type: Radiation
  intervention name: Preoperative CT Scan
  description: Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.
  arm group label: Shoulder Arthroplasty
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Elliott Goff, PhD
  role: Study Chair
  affiliation: Zimmer, GmbH
  last name: Elliott Goff, PhD
  phone: 41792222308
  email: elliott.goff@zimmerbiomet.com
  last name: Ghislain Maquer
  email: ghislain.maquer@zimmerbiomet.com
  facility: 
  contact: 
  country: Japan
  responsible party type: Sponsor
  mesh term: Rotator Cuff Injuries
  sharing ipd: No