<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/NCT03806842</url>
  </required_header>
  <id_info>
    <org_study_id>FXUSA2018-01</org_study_id>
    <nct_id>NCT03806842</nct_id>
  </id_info>
  <brief_title>Easytech Reversed Shoulder System Clinical Study</brief_title>
  <official_title>Pivotal, Non-Randomized, Historically Controlled, Prospective, Multi-Center Clinical Study of the Easytech Reversed Shoulder System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FX Shoulder USA, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FX Shoulder USA, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to collect data to demonstrate the safety and effectiveness of&#xD;
      the Easytech Reversed Shoulder System for the treatment of patients who require a reverse&#xD;
      total shoulder arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical study will enroll patient who require a reverse total shoulder arthroplasty as a&#xD;
      result of osteoarthritis, post-traumatic arthritis, avascular necrosis and have a massive and&#xD;
      non-repairable rotator cuff tear and a functional deltoid muscle.&#xD;
&#xD;
      If patients meet the eligibility criteria, evaluations and x-rays will be completed&#xD;
      pre-operatively and post-operatively out to 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Anticipated">December 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2023</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>
    <intervention_model_description>single arm, historically controlled, multi-center</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking due to being a single arm study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adjusted Constant-Murley Score</measure>
    <time_frame>24 months post-operative</time_frame>
    <description>adjusted Constant Score of 70 or greater, no humeral radiolucency &gt;2mm or humeral migration/subsidence &gt;5mm, no revision surgery, no serious device related adverse event</description>
  </primary_outcome>
  <primary_outcome>
    <measure>no humeral radiolucency &gt;2mm around the humeral component</measure>
    <time_frame>24 months post-operative</time_frame>
    <description>on review of x-rays, there are no radiolucencies &gt;2mm around the humeral component</description>
  </primary_outcome>
  <primary_outcome>
    <measure>no subsidence or migration of the humeral component &gt;5mm</measure>
    <time_frame>24 months post-operative</time_frame>
    <description>on review of x-rays, there is no subsidence or migration of the humeral component greater than or equal to 5mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>no revision</measure>
    <time_frame>24 months post-operative</time_frame>
    <description>there is no revision of the humeral components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>no serious device related adverse event</measure>
    <time_frame>24 months post-operative</time_frame>
    <description>there is no serious device related adverse event reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QuickDASH</measure>
    <time_frame>24 months post-operative</time_frame>
    <description>measures the ability to complete tasks, absorb forces and severity of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale for Pain (VAS)</measure>
    <time_frame>24 months post-operative</time_frame>
    <description>on 100 point scale where 0 is no pain and 100 is severe pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeon (ASES)</measure>
    <time_frame>24 months post-operative</time_frame>
    <description>patient-reported outcomes with questions on function and pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion of the shoulder joint</measure>
    <time_frame>24 months</time_frame>
    <description>forward and lateral elevation, internal &amp; external rotation arm at side</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Osteo Arthritis Shoulders</condition>
  <condition>Avascular Necrosis of the Head of Humerus</condition>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Easytech group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients who require a reverse total shoulder, meet the eligibility criteria and receive the Easytech Reversed Shoulder System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Easytech group</intervention_name>
    <description>total shoulder replacement</description>
    <arm_group_label>Easytech group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients are 21 years or older.&#xD;
&#xD;
          2. Patients are skeletally mature as evident by scapula and proximal humerus closure.&#xD;
&#xD;
          3. Patients exhibit clinical indications for primary reverse total shoulder arthroplasty&#xD;
             based on physical exam and medical history including the following: osteoarthritis,&#xD;
             post-traumatic arthritis, or avascular necrosis.&#xD;
&#xD;
          4. Patients have a massive and non-repairable rotator cuff tear.&#xD;
&#xD;
          5. Patients have a functional deltoid muscle.&#xD;
&#xD;
          6. Patients are anatomically and structurally suited to receive the implants;&#xD;
&#xD;
             a. Subject show sufficient bone quality in the humerus bone intraoperatively via the&#xD;
             thumb test, guide pin test, humeral punch test, and humeral anchor test as outlined in&#xD;
             the surgical technique.&#xD;
&#xD;
          7. Patients with an adjusted Constant Score &lt; 60 and ≥ 15.&#xD;
&#xD;
          8. Patients are willing and able to comply with the follow-up schedule and evaluation&#xD;
             outlined in the protocol.&#xD;
&#xD;
          9. Patient are willing and able to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with Body Mass Index (BMI) greater than 40 kg/m2.&#xD;
&#xD;
          2. Patients have one of the following compromising the affected limb: a significant&#xD;
             injury to the upper brachial plexus, paralysis of the axillary nerve or a&#xD;
             neuromuscular disease compromising the affected limb which would render the procedure&#xD;
             unjustifiable.&#xD;
&#xD;
          3. Patients have marked bone loss that would not allow sufficient support of the implant.&#xD;
&#xD;
          4. Patients have a known sensitivity or allergic reaction to one or more of the implanted&#xD;
             materials.&#xD;
&#xD;
          5. Patients who are participating concurrently in another clinical study, or have&#xD;
             participated in a clinical study within the last 90 days, or intend to during the&#xD;
             course of the study.&#xD;
&#xD;
          6. Patients who have an active systemic infection, or an active local infection in or&#xD;
             near the target shoulder, or have a previous history of joint infection.&#xD;
&#xD;
          7. Patients with known immunodeficiency.&#xD;
&#xD;
          8. Patients currently taking &gt; 5mg/day corticosteroids (e.g. prednisone) excluding&#xD;
             inhalers, within 3 months prior to surgery.&#xD;
&#xD;
          9. Patients with significant comorbidities as evident by an American Society of&#xD;
             Anesthesiologists (ASA) score greater than 3.&#xD;
&#xD;
         10. Patients with active neoplastic disease.&#xD;
&#xD;
         11. Patients with current drug or alcohol abuse, or a history of the same within the last&#xD;
             6 months.&#xD;
&#xD;
         12. Patients with local circulatory problems, (e.g. thrombophlebitis and lymphedema).&#xD;
&#xD;
         13. Patients are pregnant or expect to become pregnant during the duration of the study.&#xD;
&#xD;
         14. Patients with any mental or psychological disorder that would impair their ability to&#xD;
             complete the study questionnaires.&#xD;
&#xD;
         15. Patients with any medical condition or other circumstances that might interfere with&#xD;
             their ability to return for follow-up visits in the judgment of the Investigator,&#xD;
             including any systemic illness, neuromuscular, neurosensory, or musculoskeletal&#xD;
             deficiency that would render the patient unable to perform appropriate postoperative&#xD;
             rehabilitation.&#xD;
&#xD;
         16. Any condition which, in the judgment of the Investigator, would preclude adequate&#xD;
             evaluation of device's safety and performance.&#xD;
&#xD;
         17. Patients with humeral or glenoid fractures.&#xD;
&#xD;
         18. Patients unable to stand from sitting position without the use of their hands/arms.&#xD;
&#xD;
         19. Patients with a history of fragility fractures as defined as any fall from a standing&#xD;
             height or less, that results in a fracture.&#xD;
&#xD;
         20. Patients with osteoporosis, osteopenia, Paget's disease, osteomalacia or any other&#xD;
             metabolic bone disease; a. Osteoporosis is defined as Simple Calculated Osteoporosis&#xD;
             Risk Estimation (SCORE) above 6 and DXA (Dual-energy X-ray absorptiometry) T-score &lt;&#xD;
             -2.5 or QCT (Quantitative computed tomography) T-score &lt; 80mg/cubic cm. History of a&#xD;
             fragility fracture requires that a DXA scan or QCT scan is completed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathy Trier, PhD</last_name>
    <role>Study Director</role>
    <affiliation>FX Shoulder USA, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The CORE Institute</name>
      <address>
        <city>Sun City West</city>
        <state>Arizona</state>
        <zip>85375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dearborn &amp; Associates Institute for Joint Reconstruction</name>
      <address>
        <city>Menlo Park</city>
        <state>California</state>
        <zip>94027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedics Rhode Island</name>
      <address>
        <city>Wakefield</city>
        <state>Rhode Island</state>
        <zip>02879</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Orthopedic Specialists</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carrell Clinic</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>June 20, 2022</last_update_submitted>
  <last_update_submitted_qc>June 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>shoulder arthroplasty</keyword>
  <keyword>reverse shoulder replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Necrosis</mesh_term>
    <mesh_term>Rotator Cuff Injuries</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/NCT03806842
org study id: FXUSA2018-01
nct id: NCT03806842
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of the study is to collect data to demonstrate the safety and effectiveness of
      the Easytech Reversed Shoulder System for the treatment of patients who require a reverse
      total shoulder arthroplasty.
The clinical study will enroll patient who require a reverse total shoulder arthroplasty as a
      result of osteoarthritis, post-traumatic arthritis, avascular necrosis and have a massive and
      non-repairable rotator cuff tear and a functional deltoid muscle.

      If patients meet the eligibility criteria, evaluations and x-rays will be completed
      pre-operatively and post-operatively out to 24 months.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single arm, historically controlled, multi-center
primary purpose: Treatment
masking: None (Open Label)
masking description: no masking due to being a single arm study
measure: Adjusted Constant-Murley Score
time frame: 24 months post-operative
description: adjusted Constant Score of 70 or greater, no humeral radiolucency >2mm or humeral migration/subsidence >5mm, no revision surgery, no serious device related adverse event
measure: no humeral radiolucency >2mm around the humeral component
time frame: 24 months post-operative
description: on review of x-rays, there are no radiolucencies >2mm around the humeral component
measure: no subsidence or migration of the humeral component >5mm
time frame: 24 months post-operative
description: on review of x-rays, there is no subsidence or migration of the humeral component greater than or equal to 5mm
measure: no revision
time frame: 24 months post-operative
description: there is no revision of the humeral components
measure: no serious device related adverse event
time frame: 24 months post-operative
description: there is no serious device related adverse event reported
measure: QuickDASH
time frame: 24 months post-operative
description: measures the ability to complete tasks, absorb forces and severity of symptoms
measure: Visual Analog Scale for Pain (VAS)
time frame: 24 months post-operative
description: on 100 point scale where 0 is no pain and 100 is severe pain
measure: American Shoulder and Elbow Surgeon (ASES)
time frame: 24 months post-operative
description: patient-reported outcomes with questions on function and pain
measure: Range of Motion of the shoulder joint
time frame: 24 months
description: forward and lateral elevation, internal & external rotation arm at side
arm group label: Easytech group
arm group type: Experimental
description: patients who require a reverse total shoulder, meet the eligibility criteria and receive the Easytech Reversed Shoulder System
intervention type: Device
intervention name: Easytech group
description: total shoulder replacement
arm group label: Easytech group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kathy Trier, PhD
role: Study Director
affiliation: FX Shoulder USA, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Necrosis
mesh term: Rotator Cuff Injuries