<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/NCT03806881</url>
  </required_header>
  <id_info>
    <org_study_id>SMAT009</org_study_id>
    <nct_id>NCT03806881</nct_id>
  </id_info>
  <brief_title>Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant</brief_title>
  <official_title>Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Materialise</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Materialise</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>
      This post-market follow-up study investigates improvement in clinical and radiological&#xD;
      outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid&#xD;
      Reconstruction system&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Glenius glenoid implant is a solution for patients who need a reversed glenoid&#xD;
      reconstruction (primary or revision) because of a severely damaged glenoid associated with&#xD;
      severe bone loss. In these cases, standard reconstruction of the glenoid is not possible&#xD;
      because of the lack of body support of the glenoid rim or columns.&#xD;
&#xD;
      The Glenius implant is custom-made prothesis: during pre-operative planning, the implant is&#xD;
      designed based on a detailed 3D CT analysis of the defect with special reference to bone&#xD;
      quality and the anatomy of the bone deficient glenoid. Optimized screw fixation trajectories&#xD;
      are defined for each individual patient, which accommodate screws that are positioned and&#xD;
      angled towards the best bone stock available in the glenoid/coracoid/scapula with each&#xD;
      specific patient. The surgeon provides feedback on the the design and orientation of the&#xD;
      implant needed to achieve the optimal inclination of the head and the position &amp; offset of&#xD;
      the joint's centre of rotation.&#xD;
&#xD;
      Because Glenius is a relatively new product and only for use in specific and complex cases of&#xD;
      severy glenoid erosion, follow-up data on the clinical and radiological outcome are scarce.&#xD;
      With this study we aim to collect long-term clinical and radiological follow-up data for&#xD;
      patients treated with Glenius in a uniform, standardized way.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>Change in baseline Constant-Murley Score after surgery</measure>
    <time_frame>6 weeks, 3 months, 1 year, 2 year, 5 years after surgery</time_frame>
    <description>The Constant-Murley score is a clinical outcome scale composed of a number of individual parameters, defining the level of pain, the ability to carry out the normal daily activities of the patient, mobility and strength of the arm. The scores range from 0 (worst clinical outcome) to 100 (best clinical outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in baseline Simple Shoulder Test (SST) after surgery</measure>
    <time_frame>6 weeks, 3 months, 1 year, 2 year, 5 years after surgery</time_frame>
    <description>The SST is a function scale with 12 items, used to assess improvement in shoulder function after treatment interventions and to check the patient's ability to tolerate or perform 12 activities of daily living. The scores range from 0 (worst functional outcome) to 100 (best functional outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline Oxford Shoulder Score (OSS) after surgery</measure>
    <time_frame>6 weeks, 3 months, 1 year, 2 year, 5 years after surgery</time_frame>
    <description>The OSS is a 12-item patient-reported outcome specifically designed and developed 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. The score ranges from 0 (no pain or functional impairement) to 60 (worst pain and functional impairement).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in general health EQ5D score after surgery</measure>
    <time_frame>6 weeks, 3 months, 1 year, 2 year, 5 years after surgery</time_frame>
    <description>EQ-5D is a standardized patient-reported outcome for measuring generic health status. The questionnaire has two components: a health state description measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. and a general evaluation of their overall health status using the visual analogue scale (EQ-VAS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in baseline pain score using Visual Analogue Scales (VAS) after surgery</measure>
    <time_frame>6 weeks, 3 months, 1 year, 2 year, 5 years after surgery</time_frame>
    <description>The VAS pain score is a patient-reported evaluation of pain intensity on a Visual Analogue Scales (VAS) between 0 (no pain) and 100 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Translational deviation from planned implant position</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>translational deviation (in mm) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotational deviation from planned implant position</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>Rotational deviation (in degrees) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Translational deviation from initial implant position</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>translational deviation (in mm) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotational deviation from initial implant position</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Rotational deviation (in degrees) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scapular notching</measure>
    <time_frame>6 weeks, 3 months, 1 year, 2 years, 5 years after surgery</time_frame>
    <description>scapular notching will be graded according to the Sirveaux classification system (2004) on a shoulder radiograph. The classification goes from 0 (no notching) to 4 (erosion over the inferior screw with extension under the baseplate)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiolucensies</measure>
    <time_frame>6 weeks, 3 months, 1 year, 2 years, 5 years after surgery</time_frame>
    <description>Radiolucencies surrounding the glenoid component will be graded according to the system of Lazarus (Lazarus et al 2002) on a shoulder radiograph. The classification goes from 0 (no lucensies) to 5 (gross lucensies and radiographic loosening)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heterotopic ossifications</measure>
    <time_frame>6 weeks, 3 months, 1 year, 2 years, 5 years after surgery</time_frame>
    <description>periarticular heterotopic ossification (HO) will be scored according to a modified Brooker classification system of HO of the hip (Verhofste et al 2016) on a shoulder radiograph. The classification goes from 0 (no ossifications) to 3 (complete ankylosis of the shoulder)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of implant revision surgeries up to 5 years after surgery</measure>
    <time_frame>up to 5 years after surgery</time_frame>
    <description>Implant survival will be calculated by calculating the rate of implant revision surgeries up to 5 years after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>up to 5 year after surgery</time_frame>
    <description>the number and kind of (severe) adverse (device) events: device/shoulder related A(D)Es, SA(D)Es and device deficiencies that could have led to an SAE will be collected.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Arthroplasty, Replacement, Shoulder</condition>
  <condition>Glenoid Cavity</condition>
  <condition>Osteoarthritis of the Shoulder</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <description>Patients treated with a Glenius Glenoid Reconstruction System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>reversed glenoid prothesis</intervention_name>
    <description>All patients will undergo a primary or revision arthroplasty with Glenius according to the routine practice at the investigation site and will be followed at specified visiting moments, during which radiological and clinical data will be gathered.</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>Glenius Glenoid Reconstruction system</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of patients having primary or revision shoulder joint&#xD;
        replacement with severe glenoid bone defects caused by:(1) Non-inflammatory degenerative&#xD;
        joint disease including osteoarthritis and avascular necrosis, (2) Inflammatory&#xD;
        degenerative joint disease such as rheumatoid arthritis or (3) Congenital malformations,&#xD;
        posttraumatic deformities or removal of components during revision surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients having primary or revision shoulder joint replacement with severe glenoid&#xD;
             bone defects&#xD;
&#xD;
          -  Patient is 18 years of age or older&#xD;
&#xD;
          -  Patient can follow the Glenius system procedure that is standard of care&#xD;
&#xD;
          -  Patient is willing to cooperate in the required post-operative therapy&#xD;
&#xD;
          -  Patient has participated in the informed consent process and has signed the EC&#xD;
             approved informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Skeletally immature patients&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AZ St-Elisabeth</name>
      <address>
        <city>Herentals</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Leuven - Orthopedics</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Leuven - Traumatology</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier DeGraaf Gasthuis</name>
      <address>
        <city>Delft</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint-Maartenskliniek</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</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>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03806881
org study id: SMAT009
nct id: NCT03806881
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This post-market follow-up study investigates improvement in clinical and radiological
      outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid
      Reconstruction system
The Glenius glenoid implant is a solution for patients who need a reversed glenoid
      reconstruction (primary or revision) because of a severely damaged glenoid associated with
      severe bone loss. In these cases, standard reconstruction of the glenoid is not possible
      because of the lack of body support of the glenoid rim or columns.

      The Glenius implant is custom-made prothesis: during pre-operative planning, the implant is
      designed based on a detailed 3D CT analysis of the defect with special reference to bone
      quality and the anatomy of the bone deficient glenoid. Optimized screw fixation trajectories
      are defined for each individual patient, which accommodate screws that are positioned and
      angled towards the best bone stock available in the glenoid/coracoid/scapula with each
      specific patient. The surgeon provides feedback on the the design and orientation of the
      implant needed to achieve the optimal inclination of the head and the position & offset of
      the joint's centre of rotation.

      Because Glenius is a relatively new product and only for use in specific and complex cases of
      severy glenoid erosion, follow-up data on the clinical and radiological outcome are scarce.
      With this study we aim to collect long-term clinical and radiological follow-up data for
      patients treated with Glenius in a uniform, standardized way.
observational model: Cohort
time perspective: Prospective
measure: Change in baseline Constant-Murley Score after surgery
time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
description: The Constant-Murley score is a clinical outcome scale composed of a number of individual parameters, defining the level of pain, the ability to carry out the normal daily activities of the patient, mobility and strength of the arm. The scores range from 0 (worst clinical outcome) to 100 (best clinical outcome).
measure: Change in baseline Simple Shoulder Test (SST) after surgery
time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
description: The SST is a function scale with 12 items, used to assess improvement in shoulder function after treatment interventions and to check the patient's ability to tolerate or perform 12 activities of daily living. The scores range from 0 (worst functional outcome) to 100 (best functional outcome).
measure: Change in baseline Oxford Shoulder Score (OSS) after surgery
time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
description: The OSS is a 12-item patient-reported outcome specifically designed and developed 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. The score ranges from 0 (no pain or functional impairement) to 60 (worst pain and functional impairement).
measure: change in general health EQ5D score after surgery
time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
description: EQ-5D is a standardized patient-reported outcome for measuring generic health status. The questionnaire has two components: a health state description measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. and a general evaluation of their overall health status using the visual analogue scale (EQ-VAS).
measure: change in baseline pain score using Visual Analogue Scales (VAS) after surgery
time frame: 6 weeks, 3 months, 1 year, 2 year, 5 years after surgery
description: The VAS pain score is a patient-reported evaluation of pain intensity on a Visual Analogue Scales (VAS) between 0 (no pain) and 100 (worst pain imaginable).
measure: Translational deviation from planned implant position
time frame: 6 weeks after surgery
description: translational deviation (in mm) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.
measure: Rotational deviation from planned implant position
time frame: 6 weeks after surgery
description: Rotational deviation (in degrees) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.
measure: Translational deviation from initial implant position
time frame: 1 year after surgery
description: translational deviation (in mm) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.
measure: Rotational deviation from initial implant position
time frame: 1 year after surgery
description: Rotational deviation (in degrees) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.
measure: Scapular notching
time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
description: scapular notching will be graded according to the Sirveaux classification system (2004) on a shoulder radiograph. The classification goes from 0 (no notching) to 4 (erosion over the inferior screw with extension under the baseplate)
measure: Radiolucensies
time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
description: Radiolucencies surrounding the glenoid component will be graded according to the system of Lazarus (Lazarus et al 2002) on a shoulder radiograph. The classification goes from 0 (no lucensies) to 5 (gross lucensies and radiographic loosening)
measure: Heterotopic ossifications
time frame: 6 weeks, 3 months, 1 year, 2 years, 5 years after surgery
description: periarticular heterotopic ossification (HO) will be scored according to a modified Brooker classification system of HO of the hip (Verhofste et al 2016) on a shoulder radiograph. The classification goes from 0 (no ossifications) to 3 (complete ankylosis of the shoulder)
measure: rate of implant revision surgeries up to 5 years after surgery
time frame: up to 5 years after surgery
description: Implant survival will be calculated by calculating the rate of implant revision surgeries up to 5 years after surgery.
measure: Complication rate
time frame: up to 5 year after surgery
description: the number and kind of (severe) adverse (device) events: device/shoulder related A(D)Es, SA(D)Es and device deficiencies that could have led to an SAE will be collected.
arm group label: Treatment group
description: Patients treated with a Glenius Glenoid Reconstruction System
intervention type: Device
intervention name: reversed glenoid prothesis
description: All patients will undergo a primary or revision arthroplasty with Glenius according to the routine practice at the investigation site and will be followed at specified visiting moments, during which radiological and clinical data will be gathered.
arm group label: Treatment group
other name: Glenius Glenoid Reconstruction system
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Netherlands
responsible party type: Sponsor
mesh term: Osteoarthritis
sharing ipd: No