<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/NCT03270982</url>
  </required_header>
  <id_info>
    <org_study_id>ORTHO.CR.GE5</org_study_id>
    <nct_id>NCT03270982</nct_id>
  </id_info>
  <brief_title>Comprehensive Segmental Revision System</brief_title>
  <official_title>Comprehensive Segmental Revision System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical Data evaluation to document the performance and clinical outcomes of the&#xD;
      Comprehensive Segmental Revision System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Purpose of this multi centre clinical data evaluation is to document the performance and&#xD;
      clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be&#xD;
      collated and used to provide feedback to designing engineers, support marketing efforts,&#xD;
      answer potential questions from reimbursement agencies, and will serve as part of Zimmer&#xD;
      Biomets Post Market Surveillance.&#xD;
&#xD;
      The Comprehensive Segmental Revision System consists of a proximal humeral replacement system&#xD;
      (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total&#xD;
      humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).&#xD;
&#xD;
      Patient outcomes will be measured by using measurement tools that have been extensively used&#xD;
      and referred to in the literature. Specifically, the quickDASH will be used for all cases&#xD;
      enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder&#xD;
      applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score&#xD;
      may be used for tumor cases.&#xD;
&#xD;
      The study population will be compromised of males and females that are eligible according to&#xD;
      the inclusion/exclusion criteria. The study will last for at least five (5) years from the&#xD;
      time of surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">December 2031</completion_date>
  <primary_completion_date type="Anticipated">April 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant survivorship assessed according to the implant revisions</measure>
    <time_frame>10 years</time_frame>
    <description>Implant survivorship assessed counting the number of implant revisions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical patient outcome measure: QuickDASH</measure>
    <time_frame>Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative</time_frame>
    <description>The QuickDASH score will be used to measure physical function and symptoms of the upper limb in patients to be treated/treated with the Comprehensive SRS products.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical patient outcome measure: Constant-Murley Score</measure>
    <time_frame>Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative</time_frame>
    <description>The Constant-Murley score may be used to define the level of pain and the ability to carry out the normal daily activities in patients to be treated/treated with the Comprehensive SRS products. The score consists of objective (ROM, strength) and subjective (pain, functional assessment) variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical patient outcome measure: Liverpool Elbow Score</measure>
    <time_frame>Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative</time_frame>
    <description>The Liverpool Elbow Score may be used to define elbow condition, function and pain in patients to be treated/treated with the Comprehensive SRS products.The score consists of two components: one patient-rated part and another part that can be measured objectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS)</measure>
    <time_frame>6 months, 1 year, 3 years and 5 years post-operative</time_frame>
    <description>The MSTS Score may be used as a functional measure for patients with sarcoma involving the upper limb. The score includes 6 measures (pain, function, emotional acceptance, hand position, manual dexterity, lifting ability) each measure with a maximum of 5 points. The maximum overall score is 30 points. The score is designed to be used after the procedure and is therefore only collected post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety is assessed according to the number of complications</measure>
    <time_frame>10 years</time_frame>
    <description>Safety is assessed according to the number of complications which are collected via adverse event forms</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Degenerative Disease</condition>
  <condition>Oncology</condition>
  <condition>Revision Surgery</condition>
  <condition>Trauma</condition>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Comprehensive SRS Replacement</arm_group_label>
    <description>Comprehensive SRS Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comprehensive SRS Replacement</intervention_name>
    <description>This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.</description>
    <arm_group_label>Comprehensive SRS Replacement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population will come from Primary Care Clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular&#xD;
             necrosis&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Revision where other devices or treatments have failed&#xD;
&#xD;
          -  Correction of functional deformity&#xD;
&#xD;
          -  Oncology applications including bone loss due to tumour resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sepsis ( active)&#xD;
&#xD;
          -  Infection ( active)&#xD;
&#xD;
          -  Osteomyelitis (active)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hassan Achakri</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Operations Director Zimmer Biomet EMEA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carina Hafner</last_name>
    <phone>+41 79 707 30 93</phone>
    <email>carina.hafner@zimmerbiomet.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lisa To</last_name>
    <phone>+32 479 97 05 43</phone>
    <email>Lisa.To@zimmerbiomet.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nova Scotia Health Authority</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H-1796</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Trask</last_name>
    </contact>
    <investigator>
      <last_name>Michael Biddulph</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Orthopedic Surgery, Rigshospitalet University of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Gwent Hospital</name>
      <address>
        <city>Newport</city>
        <state>Wales</state>
        <zip>NP20 2UB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huw Pullen, MD</last_name>
      <phone>+441633 234839</phone>
      <email>pullenhuw@Hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Liverpool University Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yin Qi, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Denmark</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non Inflammatory Degenerative Joint Disease</keyword>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Revision where other devices have failed</keyword>
  <keyword>Correction of functional deformity</keyword>
  <keyword>Oncology Applications</keyword>
  <keyword>Treatment of acute or Chronic fractures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT03270982
org study id: ORTHO.CR.GE5
nct id: NCT03270982
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Clinical Data evaluation to document the performance and clinical outcomes of the
      Comprehensive Segmental Revision System.
The Purpose of this multi centre clinical data evaluation is to document the performance and
      clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be
      collated and used to provide feedback to designing engineers, support marketing efforts,
      answer potential questions from reimbursement agencies, and will serve as part of Zimmer
      Biomets Post Market Surveillance.

      The Comprehensive Segmental Revision System consists of a proximal humeral replacement system
      (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total
      humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).

      Patient outcomes will be measured by using measurement tools that have been extensively used
      and referred to in the literature. Specifically, the quickDASH will be used for all cases
      enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder
      applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score
      may be used for tumor cases.

      The study population will be compromised of males and females that are eligible according to
      the inclusion/exclusion criteria. The study will last for at least five (5) years from the
      time of surgery.
observational model: Cohort
time perspective: Other
measure: Implant survivorship assessed according to the implant revisions
time frame: 10 years
description: Implant survivorship assessed counting the number of implant revisions
measure: Clinical patient outcome measure: QuickDASH
time frame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
description: The QuickDASH score will be used to measure physical function and symptoms of the upper limb in patients to be treated/treated with the Comprehensive SRS products.
measure: Clinical patient outcome measure: Constant-Murley Score
time frame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
description: The Constant-Murley score may be used to define the level of pain and the ability to carry out the normal daily activities in patients to be treated/treated with the Comprehensive SRS products. The score consists of objective (ROM, strength) and subjective (pain, functional assessment) variables.
measure: Clinical patient outcome measure: Liverpool Elbow Score
time frame: Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative
description: The Liverpool Elbow Score may be used to define elbow condition, function and pain in patients to be treated/treated with the Comprehensive SRS products.The score consists of two components: one patient-rated part and another part that can be measured objectively.
measure: Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS)
time frame: 6 months, 1 year, 3 years and 5 years post-operative
description: The MSTS Score may be used as a functional measure for patients with sarcoma involving the upper limb. The score includes 6 measures (pain, function, emotional acceptance, hand position, manual dexterity, lifting ability) each measure with a maximum of 5 points. The maximum overall score is 30 points. The score is designed to be used after the procedure and is therefore only collected post-operatively.
measure: Safety is assessed according to the number of complications
time frame: 10 years
description: Safety is assessed according to the number of complications which are collected via adverse event forms
arm group label: Comprehensive SRS Replacement
description: Comprehensive SRS Device
intervention type: Device
intervention name: Comprehensive SRS Replacement
description: This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.
arm group label: Comprehensive SRS Replacement
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hassan Achakri
role: Study Director
affiliation: Clinical Operations Director Zimmer Biomet EMEA
last name: Carina Hafner
phone: +41 79 707 30 93
email: carina.hafner@zimmerbiomet.com
last name: Lisa To
phone: +32 479 97 05 43
email: Lisa.To@zimmerbiomet.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Canada
country: Denmark
country: United Kingdom
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid