<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/NCT01700543</url>
  </required_header>
  <id_info>
    <org_study_id>CME2012-01E</org_study_id>
    <secondary_id>1201E</secondary_id>
    <nct_id>NCT01700543</nct_id>
  </id_info>
  <brief_title>Sidus(TM) Post Market Clinical Follow-up (PMCF) Study</brief_title>
  <official_title>Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This post market clinical follow-up study is designed to confirm safety and performance of&#xD;
      the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.&#xD;
&#xD;
      The safety of the implant will be evaluated by monitoring the frequency and incidence of all&#xD;
      kinds of adverse events.&#xD;
&#xD;
      The performance will be determined by analyzing the implant survival, overall pain and&#xD;
      functional performances (based on Constant &amp; Murley score and ASES score), subject quality of&#xD;
      life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component&#xD;
      migration) of study subjects who received the Sidus Stem-Free Shoulder.&#xD;
&#xD;
      The Sidus Stem-Free Shoulder is not approved for use in the US.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, noncontrolled, multi-center post market clinical follow-up study&#xD;
      involving orthopedic surgeons skilled in hemi and total shoulder arthroplasty procedures.&#xD;
&#xD;
      A total number of 160 subjects will be included in the study.&#xD;
&#xD;
      Ethics Committee (EC) approval for each site has to be obtained prior to conducting this&#xD;
      study. Sequentially, all eligible patients will be offered study enrollment at each center to&#xD;
      avoid potential selection bias. All potential subjects will be required to participate in an&#xD;
      informed consent process and sign the EC approved written Informed Consent prior to study&#xD;
      enrollment.&#xD;
&#xD;
      The study is designed to be prospective to ensure that the study population is representative&#xD;
      of the type of population that the device is intended to treat. Patients will be selected&#xD;
      according to the subject selection criteria described in section 8. All subjects will undergo&#xD;
      preoperative, intraoperative and immediate postoperative assessments including physical&#xD;
      examinations, radiographic evaluations and collection of quality of life metrics. Follow-up&#xD;
      evaluations are to be conducted at 3 and 6 months, 1, 2, 5, 7 and 10 years postoperation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Actual">July 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Performance (Constant &amp; Murley Score)</measure>
    <time_frame>5 Years</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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival (Kaplan-Meier)</measure>
    <time_frame>10 years</time_frame>
    <description>The Kaplan-Meier (KM) method is a non-parametric method used to estimate the survival probability from observed survival times (Kaplan and Meier, 1958).&#xD;
The survival probability at time ti, S(ti), is calculated as follow:&#xD;
S(ti)=S(ti-1)(1-dini)&#xD;
Where,&#xD;
S(ti-1) = the probability of being alive at ti-1 ni = the number of patients alive just before ti di = the number of events at ti t0 = 0, S(0) = 1</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Non-inflammatory Degenerative Joint Disease (NIDJD)</condition>
  <condition>Avascular Necrosis</condition>
  <condition>Osteoarthritis</condition>
  <condition>Inflammatory Joint Disease (IJD)</condition>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Experimental: Sidus Shoulder</arm_group_label>
    <description>Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Shoulder Arthroplasty</intervention_name>
    <description>Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.</description>
    <arm_group_label>Experimental: Sidus Shoulder</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill&#xD;
        all inclusion and none of the exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is 18 to 80 years of age, inclusive.&#xD;
&#xD;
          -  The patient is skeletally mature.&#xD;
&#xD;
          -  Patient is suffering from severe shoulder pain and disability requiring unilateral or&#xD;
             bilateral HSA or TSA based on physical exam and medical history.&#xD;
&#xD;
          -  Patient has failed conservative treatment.&#xD;
&#xD;
          -  Patient meets at least one of the following indications: Osteoarthritis, Posttraumatic&#xD;
             arthrosis, Rheumatoid arthritis without humeral metaphyseal defects, Focal avascular&#xD;
             necrosis of the humeral head, Previous surgeries of the shoulder that do no compromise&#xD;
             the fixation.&#xD;
&#xD;
          -  Patient is willing and able to cooperate in the required post-operative therapy.&#xD;
&#xD;
          -  Patient is willing and able to complete scheduled follow-up evaluations as described&#xD;
             in the Informed Consent.&#xD;
&#xD;
          -  Patient has participated in the Informed Consent process and has signed the Ethics&#xD;
             Committee approved &quot;Informed Consent&quot;.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is unwilling or unable to give consent or to comply with the follow-up&#xD;
             program.&#xD;
&#xD;
          -  Patients who have any condition which would in the judgement of the Investigator place&#xD;
             the patient at undue risk or interfere with the study. Any patient who is&#xD;
             institutionalized, or is an known drug abuser, a known alcoholic or anyone who cannot&#xD;
             understand what is required of them.&#xD;
&#xD;
          -  Patient is known to be pregnant or breastfeeding.&#xD;
&#xD;
          -  Patient meets at least one of the contraindications: Soft or inadequate humeral bone&#xD;
             (including osteoporosis and extensive avascular necrosis or rheumatoid arthritis)&#xD;
             leading to poor implant fixation, Metaphyseal bony defect (including large cysts),&#xD;
             Posttraumatic tuberosity non-union, Signs of infection, Irreparable cuff tear,&#xD;
             Revision from a failed stemmed prosthesis, Charcot's shoulder (neuroarthropathy)&#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>Elliott Goff, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Zimmer Biomet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AKH Linz</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Chirurgical Thiers</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedische Chirurgie Muenchen</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis am Wall</name>
      <address>
        <city>Rinteln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Careggi</name>
      <address>
        <city>Florence</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Royal Infirmary of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</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 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stemless shoulder implant</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Hemi Shoulder Arthroplasty</keyword>
  <keyword>Total Shoulder Arthroplasty</keyword>
  <keyword>Prospective</keyword>
  <keyword>Multi-center</keyword>
  <keyword>Europe</keyword>
  <keyword>Non-Controlled</keyword>
  <keyword>Good Bone Stock</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Necrosis</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/NCT01700543
org study id: CME2012-01E
secondary id: 1201E
nct id: NCT01700543
lead sponsor: 
collaborator: 
has dmc: No
This post market clinical follow-up study is designed to confirm safety and performance of
      the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.

      The safety of the implant will be evaluated by monitoring the frequency and incidence of all
      kinds of adverse events.

      The performance will be determined by analyzing the implant survival, overall pain and
      functional performances (based on Constant & Murley score and ASES score), subject quality of
      life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component
      migration) of study subjects who received the Sidus Stem-Free Shoulder.

      The Sidus Stem-Free Shoulder is not approved for use in the US.
This study is a prospective, noncontrolled, multi-center post market clinical follow-up study
      involving orthopedic surgeons skilled in hemi and total shoulder arthroplasty procedures.

      A total number of 160 subjects will be included in the study.

      Ethics Committee (EC) approval for each site has to be obtained prior to conducting this
      study. Sequentially, all eligible patients will be offered study enrollment at each center to
      avoid potential selection bias. All potential subjects will be required to participate in an
      informed consent process and sign the EC approved written Informed Consent prior to study
      enrollment.

      The study is designed to be prospective to ensure that the study population is representative
      of the type of population that the device is intended to treat. Patients will be selected
      according to the subject selection criteria described in section 8. All subjects will undergo
      preoperative, intraoperative and immediate postoperative assessments including physical
      examinations, radiographic evaluations and collection of quality of life metrics. Follow-up
      evaluations are to be conducted at 3 and 6 months, 1, 2, 5, 7 and 10 years postoperation.
observational model: Cohort
time perspective: Prospective
measure: Functional Performance (Constant & Murley Score)
time frame: 5 Years
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.
measure: Survival (Kaplan-Meier)
time frame: 10 years
description: The Kaplan-Meier (KM) method is a non-parametric method used to estimate the survival probability from observed survival times (Kaplan and Meier, 1958).
The survival probability at time ti, S(ti), is calculated as follow:
S(ti)=S(ti-1)(1-dini)
Where,
S(ti-1) = the probability of being alive at ti-1 ni = the number of patients alive just before ti di = the number of events at ti t0 = 0, S(0) = 1
arm group label: Experimental: Sidus Shoulder
description: Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria.
intervention type: Procedure
intervention name: Shoulder Arthroplasty
description: Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.
arm group label: Experimental: Sidus Shoulder
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Elliott Goff, PhD
role: Study Chair
affiliation: Zimmer Biomet
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: France
country: Germany
country: Italy
country: United Kingdom
country: Switzerland
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Osteoarthritis
mesh term: Arthritis, Rheumatoid
mesh term: Joint Diseases
mesh term: Necrosis