<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/NCT04431973</url>
  </required_header>
  <id_info>
    <org_study_id>DR190289-MSS</org_study_id>
    <secondary_id>2019-A03228-49</secondary_id>
    <nct_id>NCT04431973</nct_id>
  </id_info>
  <brief_title>Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.</brief_title>
  <acronym>MSS</acronym>
  <official_title>Étude Post-marché, Prospective, Multicentrique, Ouverte, d'évaluation de la prothèse Totale d'épaule inversée Medacta Shoulder System.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</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 goal of this study is to evaluate the performance of the Medacta Shoulder System total&#xD;
      reverse shoulder prosthesis, at 2 years of follow up, in patients who required this&#xD;
      prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post&#xD;
      instability arthropathy.&#xD;
&#xD;
      The main goal is to evaluate at 2 years post-operatively the shoulder function of patients.&#xD;
      The secondary goals are to assess the rate of complications, the survival rate of Reverse&#xD;
      Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in&#xD;
      contact with the humeral stem, Patient satisfaction and evolution of shoulder function in&#xD;
      patients at 3 months and 1 year post-surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, national, multicenter, non-controlled, non-randomized study in&#xD;
      order to evaluate outcomes of the MSS reverse prosthesis used for the management of primary&#xD;
      osteoarthritis, cuff tear arthropathy, massive cuff tear, or post-instability arthroplasty.&#xD;
&#xD;
      Included patients, will have an oral and written information about the study, including the&#xD;
      information note, during a preoperative visit. The surgeon will answer any questions that may&#xD;
      arise and will collect their decision after sufficient time for the patient to reflect.&#xD;
&#xD;
      Patients participating in the research will be able to withdraw their consent and ask to stop&#xD;
      the study at any time and for any reason. The investigator should document the reasons as&#xD;
      fully as possible.&#xD;
&#xD;
      Patients will be followed according to the schedule below:&#xD;
&#xD;
        -  V1 : Inclusion during a preoperative visit&#xD;
&#xD;
        -  V2: Surgery maximum 4 months after inclusion&#xD;
&#xD;
        -  V3: Follow-up visit at 3 months ± 1 month post-surgery&#xD;
&#xD;
        -  V4: Follow-up visit at 12 months ± 2 months post-surgery&#xD;
&#xD;
        -  V5: Follow-up visit between 24 months and 28 months post-surgery, marking the end of&#xD;
           follow-up for the patient.&#xD;
&#xD;
      The surgical technique for implantation of the Reverse Medacta Shoulder System total shoulder&#xD;
      prosthesis will be performed according to the MyShoulder pre-operative planning (without&#xD;
      custom-made guides). All procedures will be performed with conventional instrumentation&#xD;
      according to each surgeon's current practice. It is possible to use the BIO-RSA technique to&#xD;
      reposition the pre-morbid glenoid center. The stem that will be used is the short stem&#xD;
      (cementless) with PE angulation at 145°.&#xD;
&#xD;
      The following data will be collected at each of the 3 month, 1 year and 2 year :&#xD;
&#xD;
        -  Post-operative complications as dislocation, glenoid loosening, infection, neurological&#xD;
           damage, fracture.&#xD;
&#xD;
        -  Survival of implants according to these definitions Revision: A procedure that removes&#xD;
           all or part of the original configuration of the implant, one or more of the components&#xD;
           except for the polyethylene insert* if it has been removed and restored Re-operation:&#xD;
           Any surgical procedure that does not remove, modify or add any components to the system.&#xD;
&#xD;
        -  Clinical examination: evaluation of post-operative mobility, Constant score. This&#xD;
           examination corresponds to current practice.&#xD;
&#xD;
        -  Medical Imaging: the results of the radiological examinations will be reviewed centrally&#xD;
           by independent assessors. These evaluators will collect the available data from the&#xD;
           radiographs of the AP view, axillary profile, or Neer/Lamy. The data from the scans will&#xD;
           be analyzed by each investigator and by the software.&#xD;
&#xD;
        -  Patient questionnaire If a follow-up visit is not made, the reason will be collected and&#xD;
           noted in the patient record and on the CRF. The investigator will proceed to obtain the&#xD;
           most exhaustive follow-up data possible&#xD;
&#xD;
        -  The clinical examination will be replaced by the Self-Constant Questionnaire which will&#xD;
           be sent to the patient for completion.&#xD;
&#xD;
        -  The results of available radiological examinations will be collected.&#xD;
&#xD;
        -  The patient questionnaires planned for the study (ISS score and OSS score) will be sent&#xD;
           to the patient for completion.&#xD;
&#xD;
      A web-based data collection medium will be used for this study. All the information required&#xD;
      by the protocol will be collected in a e-crf. It requires only an Internet connection and a&#xD;
      browser. A help document for the use of this tool will be provided to the investigators.&#xD;
&#xD;
      Data management for the study will be handled by a CIC INSERM 1415 data-manager. The&#xD;
      electronic case report form (eCRF) will be developed using Ennov Clinical® software. Data&#xD;
      management will be done according to the standard operating procedures (edited in CIC INSERM&#xD;
      1415. The Clinical Research Assistant in charge of the study will be trained in the use of&#xD;
      the eCRF, then will be in charge of the training of investigators. Data relating to&#xD;
      post-operative radiological data will be entered on the eCRF directly by the independent&#xD;
      assessors commissioned for the centralized review of radiological examinations.&#xD;
&#xD;
      Analyses will be performed with SAS Version 9.4 (or later). The statistical analysis will be&#xD;
      performed according to a pre-established statistical analysis plan. Missing values will not&#xD;
      be replaced by estimated values but will be considered as missing in the statistical&#xD;
      analysis.&#xD;
&#xD;
      A statistical analysis report will be written integrating all the elements to be reported.&#xD;
&#xD;
      A clinical research assistant will ensure the rigourous conduct of the study, the collection&#xD;
      of the data generated in writing, their documentation, recording and reporting, in accordance&#xD;
      with the Promotion and Quality Control Unit of the Tours CHRU as well as the legal and&#xD;
      regulatory provisions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2026</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder function by evaluation of Constant's Score</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>The main evaluation criteria is the rate of improvement of the Constant Score and preoperative and postoperative mobility (active external and internal rotation, elbow to body) at 2 years post surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>At 2 years post surgery</time_frame>
    <description>Assess the complication rate associated with the MSS prosthesis (safety of the prosthesis, safety of the prosthesis, etc.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival implants</measure>
    <time_frame>At 2 years post surgery</time_frame>
    <description>Evaluate the survival of Reverse Medacta Shoulder System implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Position of the prosthesis</measure>
    <time_frame>At 3 months, 1 year and 2 years post-surgery.</time_frame>
    <description>Evaluate the positioning of the prosthesis by radiological analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone behaviour</measure>
    <time_frame>At 3 months, 1 year and 2 years post-surgery.</time_frame>
    <description>Evaluation of bone behaviour in contact with the humeral stem</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Shoulder Value</measure>
    <time_frame>At 3 months, 1 year and 2 years post-surgery</time_frame>
    <description>Assess patient satisfaction after surgery at 3 months, 1 year and 2 years post-surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Shoulder Score</measure>
    <time_frame>At 3 months, 1 year and 2 years post-surgery</time_frame>
    <description>Assess patient satisfaction after surgery at 3 months, 1 year and 2 years post-surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder function by evaluation of Constant's Score</measure>
    <time_frame>At 3 months and 1 year post-surgery</time_frame>
    <description>Evaluate the evolution of shoulder function in patients who received a Medacta Shoulder System reverse ETP with MyShoulder preoperative planning (without custom guides).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Shoulder Prosthesis</condition>
  <arm_group>
    <arm_group_label>Shoulder prothesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluate the performance of the Medacta Shoulder System total reverse shoulder prothesis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medacta Shoulder System</intervention_name>
    <description>Surgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy</description>
    <arm_group_label>Shoulder prothesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 18 to 87 ;&#xD;
&#xD;
          -  Patient with one of the following diseases: primary omarthrosis, cuff tear&#xD;
             arthropathy, massive cuff tear or post instability arthropathy;&#xD;
&#xD;
          -  Patient in need of a total shoulder prosthesis;&#xD;
&#xD;
          -  Patient affiliated with or beneficiary of a social security scheme;&#xD;
&#xD;
          -  Patient who has given written informed consent for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with malignant diseases;&#xD;
&#xD;
          -  Patient with known or suspected infections;&#xD;
&#xD;
          -  Patient with neurological deficits that may affect shoulder function;&#xD;
&#xD;
          -  Patient with known incompatibility or allergy to product materials;&#xD;
&#xD;
          -  Patient with previous open shoulder surgery (fracture sequelae, plate or nail,&#xD;
             revision ...), treated for fractures, or suffering from rheumatoid arthritis (this&#xD;
             does not concern patients treated by arthroscopy, or bone block);&#xD;
&#xD;
          -  Protected major patient;&#xD;
&#xD;
          -  Vulnerable person according to article L1121-6 of the Public Health Code;&#xD;
&#xD;
          -  Pregnant or breastfeeding woman or woman of childbearing age;&#xD;
&#xD;
          -  Impossibility to follow the consultation schedule planned in the study (planned move&#xD;
             or mutation, etc...).&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          -  Patient with malignant diseases on the day of surgery;&#xD;
&#xD;
          -  Patient with known incompatibility or allergy to product materials on the day of&#xD;
             surgery;&#xD;
&#xD;
          -  Patient with known or suspected infections on the day of surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Luc FAVARD</last_name>
    <phone>+33 2 47 47 46 65</phone>
    <email>luc.favard@univ-tours.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elodie MOUSSET</last_name>
    <phone>+33 2 47 47 46 65</phone>
    <email>e.mousset@chu-tours.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chu Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Laurent HUBERT</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hervé THOMAZEAU</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste la Sagesse</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tewfik BENKALFATE</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Polyclinique santé atlantique</name>
      <address>
        <city>Saint-Herblain</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yves BOUJU</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luc FAVARD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04431973
org study id: DR190289-MSS
secondary id: 2019-A03228-49
nct id: NCT04431973
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to evaluate the performance of the Medacta Shoulder System total
      reverse shoulder prosthesis, at 2 years of follow up, in patients who required this
      prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post
      instability arthropathy.

      The main goal is to evaluate at 2 years post-operatively the shoulder function of patients.
      The secondary goals are to assess the rate of complications, the survival rate of Reverse
      Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in
      contact with the humeral stem, Patient satisfaction and evolution of shoulder function in
      patients at 3 months and 1 year post-surgery.
This study is a prospective, national, multicenter, non-controlled, non-randomized study in
      order to evaluate outcomes of the MSS reverse prosthesis used for the management of primary
      osteoarthritis, cuff tear arthropathy, massive cuff tear, or post-instability arthroplasty.

      Included patients, will have an oral and written information about the study, including the
      information note, during a preoperative visit. The surgeon will answer any questions that may
      arise and will collect their decision after sufficient time for the patient to reflect.

      Patients participating in the research will be able to withdraw their consent and ask to stop
      the study at any time and for any reason. The investigator should document the reasons as
      fully as possible.

      Patients will be followed according to the schedule below:

        -  V1 : Inclusion during a preoperative visit

        -  V2: Surgery maximum 4 months after inclusion

        -  V3: Follow-up visit at 3 months ± 1 month post-surgery

        -  V4: Follow-up visit at 12 months ± 2 months post-surgery

        -  V5: Follow-up visit between 24 months and 28 months post-surgery, marking the end of
           follow-up for the patient.

      The surgical technique for implantation of the Reverse Medacta Shoulder System total shoulder
      prosthesis will be performed according to the MyShoulder pre-operative planning (without
      custom-made guides). All procedures will be performed with conventional instrumentation
      according to each surgeon's current practice. It is possible to use the BIO-RSA technique to
      reposition the pre-morbid glenoid center. The stem that will be used is the short stem
      (cementless) with PE angulation at 145°.

      The following data will be collected at each of the 3 month, 1 year and 2 year :

        -  Post-operative complications as dislocation, glenoid loosening, infection, neurological
           damage, fracture.

        -  Survival of implants according to these definitions Revision: A procedure that removes
           all or part of the original configuration of the implant, one or more of the components
           except for the polyethylene insert* if it has been removed and restored Re-operation:
           Any surgical procedure that does not remove, modify or add any components to the system.

        -  Clinical examination: evaluation of post-operative mobility, Constant score. This
           examination corresponds to current practice.

        -  Medical Imaging: the results of the radiological examinations will be reviewed centrally
           by independent assessors. These evaluators will collect the available data from the
           radiographs of the AP view, axillary profile, or Neer/Lamy. The data from the scans will
           be analyzed by each investigator and by the software.

        -  Patient questionnaire If a follow-up visit is not made, the reason will be collected and
           noted in the patient record and on the CRF. The investigator will proceed to obtain the
           most exhaustive follow-up data possible

        -  The clinical examination will be replaced by the Self-Constant Questionnaire which will
           be sent to the patient for completion.

        -  The results of available radiological examinations will be collected.

        -  The patient questionnaires planned for the study (ISS score and OSS score) will be sent
           to the patient for completion.

      A web-based data collection medium will be used for this study. All the information required
      by the protocol will be collected in a e-crf. It requires only an Internet connection and a
      browser. A help document for the use of this tool will be provided to the investigators.

      Data management for the study will be handled by a CIC INSERM 1415 data-manager. The
      electronic case report form (eCRF) will be developed using Ennov Clinical® software. Data
      management will be done according to the standard operating procedures (edited in CIC INSERM
      1415. The Clinical Research Assistant in charge of the study will be trained in the use of
      the eCRF, then will be in charge of the training of investigators. Data relating to
      post-operative radiological data will be entered on the eCRF directly by the independent
      assessors commissioned for the centralized review of radiological examinations.

      Analyses will be performed with SAS Version 9.4 (or later). The statistical analysis will be
      performed according to a pre-established statistical analysis plan. Missing values will not
      be replaced by estimated values but will be considered as missing in the statistical
      analysis.

      A statistical analysis report will be written integrating all the elements to be reported.

      A clinical research assistant will ensure the rigourous conduct of the study, the collection
      of the data generated in writing, their documentation, recording and reporting, in accordance
      with the Promotion and Quality Control Unit of the Tours CHRU as well as the legal and
      regulatory provisions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Shoulder function by evaluation of Constant's Score
time frame: 2 years post surgery
description: The main evaluation criteria is the rate of improvement of the Constant Score and preoperative and postoperative mobility (active external and internal rotation, elbow to body) at 2 years post surgery.
measure: Complication rate
time frame: At 2 years post surgery
description: Assess the complication rate associated with the MSS prosthesis (safety of the prosthesis, safety of the prosthesis, etc.).
measure: Survival implants
time frame: At 2 years post surgery
description: Evaluate the survival of Reverse Medacta Shoulder System implants
measure: Position of the prosthesis
time frame: At 3 months, 1 year and 2 years post-surgery.
description: Evaluate the positioning of the prosthesis by radiological analysis
measure: Bone behaviour
time frame: At 3 months, 1 year and 2 years post-surgery.
description: Evaluation of bone behaviour in contact with the humeral stem
measure: Subjective Shoulder Value
time frame: At 3 months, 1 year and 2 years post-surgery
description: Assess patient satisfaction after surgery at 3 months, 1 year and 2 years post-surgery
measure: Oxford Shoulder Score
time frame: At 3 months, 1 year and 2 years post-surgery
description: Assess patient satisfaction after surgery at 3 months, 1 year and 2 years post-surgery
measure: Shoulder function by evaluation of Constant's Score
time frame: At 3 months and 1 year post-surgery
description: Evaluate the evolution of shoulder function in patients who received a Medacta Shoulder System reverse ETP with MyShoulder preoperative planning (without custom guides).
arm group label: Shoulder prothesis
arm group type: Experimental
description: Evaluate the performance of the Medacta Shoulder System total reverse shoulder prothesis
intervention type: Device
intervention name: Medacta Shoulder System
description: Surgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy
arm group label: Shoulder prothesis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Luc FAVARD
phone: +33 2 47 47 46 65
email: luc.favard@univ-tours.fr
last name: Elodie MOUSSET
phone: +33 2 47 47 46 65
email: e.mousset@chu-tours.fr
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor