<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/NCT04405947</url>
  </required_header>
  <id_info>
    <org_study_id>2015/7913/I</org_study_id>
    <nct_id>NCT04405947</nct_id>
  </id_info>
  <brief_title>Influenze of Approach in Reversed Shoulder Prosthesis</brief_title>
  <official_title>Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital del Mar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital del Mar</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To determine the differences in the placement of the glenoid implant of the inverted&#xD;
      prostheses when they are implanted using a superior approach and using an anterior approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inverted prostheses have proven to be effective in the treatment of all those pathologies&#xD;
      that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures,&#xD;
      sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous&#xD;
      complications have been described after the use of inverted prostheses, such as glenoid&#xD;
      erosion, infections, dislocation, or aseptic loosening. The most frequent complication&#xD;
      related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of&#xD;
      cases. This complication appears early in the evolution, usually before 2 years after&#xD;
      surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of&#xD;
      long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option&#xD;
      is to place the glenoid component low, so that if the glenoid component is flush with the&#xD;
      lower margin of the glena, the chances of developing glenoid erosion are significantly&#xD;
      reduced. Two types of approaches have been used to implant these prostheses, the&#xD;
      deltopectoral and the superior anterior approach. Each of them has its advantages and&#xD;
      disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors&#xD;
      the best placement of the glenoid component, but sacrifices the subscapularis tendon,&#xD;
      increasing the risk of dislocation of the components. On the contrary, the superior anterior&#xD;
      approach respects the subscapularis tendon, reducing the risk of dislocation of the&#xD;
      components but gives worse surgical exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2016</start_date>
  <completion_date type="Actual">October 29, 2020</completion_date>
  <primary_completion_date type="Actual">January 18, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>prospective randomized study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>given the fact that the different approaches come with different scars, just the outcomes assessor can be blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>positioning of the metaglene of the reverse shoulder prostheses</measure>
    <time_frame>2 years</time_frame>
    <description>to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>scapular notch</measure>
    <time_frame>2 years</time_frame>
    <description>determine scapular notch development in both approaches as determined with the aid of an AP X-ray view of the shoulder and thus classifying the scapular notch development according to Sirveaux et al. classification system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional outcome</measure>
    <time_frame>2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.</time_frame>
    <description>determine the functional outcome as measured with the Constant Score at 2-years follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Outcomes Assessments, Patients</condition>
  <condition>Rotator Cuff Arthropathy</condition>
  <arm_group>
    <arm_group_label>deltopectoral</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>deltopectoral surgical approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>antero-superior</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>antero-superior approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Reverse Shoulder Arthroplasty</intervention_name>
    <description>implantation of a reversed shoulder prostheses through two different surgical approaches</description>
    <arm_group_label>antero-superior</arm_group_label>
    <arm_group_label>deltopectoral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with secondary osteoarthritis of the shoulder who are candidates for an&#xD;
             inverted prosthesis&#xD;
&#xD;
          -  Acute fractures &lt;2 weeks of evolution in patients candidates for inverted prostheses&#xD;
&#xD;
          -  No previous surgeries of the affected shoulder&#xD;
&#xD;
          -  Acceptance by the patient to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fractures&gt; 2 weeks of evolution&#xD;
&#xD;
          -  Previous surgeries on the affected shoulder&#xD;
&#xD;
          -  Not signing the informed consent&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Institutionalization of the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>March 25, 2021</last_update_submitted>
  <last_update_submitted_qc>March 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital del Mar</investigator_affiliation>
    <investigator_full_name>Carlos Torrens</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>reverse shoulder arthroplasty</keyword>
  <keyword>scapular notch</keyword>
  <keyword>deltopectoral</keyword>
  <keyword>anterosuperior approach</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</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/NCT04405947
org study id: 2015/7913/I
nct id: NCT04405947
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To determine the differences in the placement of the glenoid implant of the inverted
      prostheses when they are implanted using a superior approach and using an anterior approach.
Inverted prostheses have proven to be effective in the treatment of all those pathologies
      that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures,
      sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous
      complications have been described after the use of inverted prostheses, such as glenoid
      erosion, infections, dislocation, or aseptic loosening. The most frequent complication
      related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of
      cases. This complication appears early in the evolution, usually before 2 years after
      surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of
      long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option
      is to place the glenoid component low, so that if the glenoid component is flush with the
      lower margin of the glena, the chances of developing glenoid erosion are significantly
      reduced. Two types of approaches have been used to implant these prostheses, the
      deltopectoral and the superior anterior approach. Each of them has its advantages and
      disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors
      the best placement of the glenoid component, but sacrifices the subscapularis tendon,
      increasing the risk of dislocation of the components. On the contrary, the superior anterior
      approach respects the subscapularis tendon, reducing the risk of dislocation of the
      components but gives worse surgical exposure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective randomized study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: given the fact that the different approaches come with different scars, just the outcomes assessor can be blinded
measure: positioning of the metaglene of the reverse shoulder prostheses
time frame: 2 years
description: to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.
measure: scapular notch
time frame: 2 years
description: determine scapular notch development in both approaches as determined with the aid of an AP X-ray view of the shoulder and thus classifying the scapular notch development according to Sirveaux et al. classification system.
measure: functional outcome
time frame: 2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.
description: determine the functional outcome as measured with the Constant Score at 2-years follow-up
arm group label: deltopectoral
arm group type: Other
description: deltopectoral surgical approach
arm group label: antero-superior
arm group type: Other
description: antero-superior approach
intervention type: Procedure
intervention name: Reverse Shoulder Arthroplasty
description: implantation of a reversed shoulder prostheses through two different surgical approaches
arm group label: antero-superior
arm group label: deltopectoral
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hospital del Mar
investigator full name: Carlos Torrens
investigator title: Principal investigator
mesh term: Joint Diseases