xml: <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/NCT06025448</url>
    </required_header>
    <id_info>
      <org_study_id>CARS-2</org_study_id>
      <nct_id>NCT06025448</nct_id>
    </id_info>
    <brief_title>Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?</brief_title>
    <acronym>CARS-2</acronym>
    <official_title>From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (CARS 2: Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability Measured With CT-based Motion Analysis (CTMA)?).</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lovisenberg Diakonale Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lovisenberg Diakonale Hospital</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 clinical trial will investigate whether metallic lateralization in reverse shoulder&#xD;
        arthroplasty is as stable as bony lateralization during the first two postsurgical years,&#xD;
        measured with CT-based motion analysis (CTMA).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such&#xD;
        as limited range of motion (ROM), and scapular notching, where the lower part of the scapular&#xD;
        neck becomes eroded due to impingement against the humeral component. There's several ways to&#xD;
        lateralize the glenoid component, a bone transplant placed underneath the glenoid component&#xD;
        (Bony Increased Offset Reversed Shoulder Arthroplasty: BIO-RSA) has been used for some time.&#xD;
        Recently glenoid components with metallic lateralization of the joint centre (Metal-Increased&#xD;
        Offset Reversed Shoulder Arthroplasty: MIO-RSA) have been introduced, but there is not much&#xD;
        comparative literature on metal vs. bony lateralization.&#xD;
  &#xD;
        Patients with osteoarthritis and medialization of the glenoid articular surface, who willing&#xD;
        to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA. CT-based&#xD;
        motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the&#xD;
        glenoid components to assess the stability of the prostheses up to two years after&#xD;
        implantation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2033</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2033</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Participants and health personnel examining the participants will be blinded. It will not be possible to blind the surgeons due to the nature of the intervention.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Migration of glenoid component from baseline until 24 months</measure>
      <time_frame>At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.</time_frame>
      <description>CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation.&#xD;
  The motion analysis includes measurement of translation along three orthogonal axes and rotations around two orthogonal axes. CTMA is a marker-free motion analysis, and the images are obtained on a standard CT-machine. Analysis and computation of motion data are performed using proprietary software at Sectra AB (collaborating partner)&#xD;
  CTMA is a relative new method to measure implant migration. The precision of the measurements is 0.08-0.15 mm for translation and 0.23-0.54º for rotation, therefore, CTMA is capable of measuring very small movements of the implant relative to the surrounding bone.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in WOOS Index</measure>
      <time_frame>Before randomization, 3, 12 and 24 months postoperatively.</time_frame>
      <description>The Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis.&#xD;
  There are 19 questions divided into four domains: Physical symptoms, sports and work, lifestyle and emotions. Each question is answered on a visual analogue scale ranging from 0 to 100. The overall score ranges from 0 to 1900, with 1900 being the worst. For ease of interpretation, the scores are often converted to a percentage of the maximum score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Constant-Murley Score</measure>
      <time_frame>Before randomization, 3, 12 and 24 months postoperatively.</time_frame>
      <description>The 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. The test is divided into subjective and objective components. Two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65.&#xD;
  Pain and ADL are answered by the patient; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in EuroQol-5</measure>
      <time_frame>Before randomization, 3, 12 and 24 months postoperatively.</time_frame>
      <description>he widely used EuroQol-5 (EQ-5D-5L) will be used to measure health-related quality of life.&#xD;
  The EQ5D-5L consists of two parts: A descriptive system (Mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-VAS that record patients self-rated health on a visual analog scale that range from 0 -100, higher levels indicate better self-rated health.&#xD;
  The descriptive system can be converted to a single summary index number where lower levels indicate poorer health related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in range of motion</measure>
      <time_frame>Before randomization, 3, 12 and 24 months postoperatively.</time_frame>
      <description>The patient's active and passive range of motion (ROM) in the affected shoulder will be measured by an experienced physiotherapist with a long-legged goniometer. The directions measured will be flexion, abduction, external rotation and internal rotation, measured in degrees and/or physical landmarks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Subjective Shoulder Value</measure>
      <time_frame>Before randomization, 3, 12 and 24 months postoperatively.</time_frame>
      <description>The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anchor Question 1</measure>
      <time_frame>Before randomization, 3, 12 and 24 months postoperatively.</time_frame>
      <description>This anchor question is asked to help determine Patient Acceptable Symptom State (PASS).&#xD;
  &quot;Considering all daily activities that involves your operated shoulder, your level of pain and degree of function, how satisfied are you with the condition of your shoulder is right now?&quot; Alternatives: Satisfied/somewhat satisfied/Neither satisfied or unsatisfied/somewhat unsatisfied/Unsatisfied</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anchor Question 2</measure>
      <time_frame>3, 12 and 24 months postoperatively</time_frame>
      <description>This anchor question is asked to help determine Minimal Important Difference (MID) and Substantial Clinical Benefit (SCB).&#xD;
  &quot;Think of all the ways your operated shoulder has affected you the last week. Since your surgery, has there been any change in the condition of your shoulder that you would consider important or meaningful to you?&quot; Alternatives: Much better/moderately better/a bit better/no change/a bit worse/moderately worse/Much worse</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Arthroplasty Complications</condition>
    <condition>Shoulder Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>BIO-RSA</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>MIO-RSA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>BIO-RSA</intervention_name>
      <description>Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA).</description>
      <arm_group_label>BIO-RSA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>MIO-RSA</intervention_name>
      <description>Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA).</description>
      <arm_group_label>MIO-RSA</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eligible for primary RSA due to OA, massive RC tear, failed RC repair or&#xD;
               post-instability osteoarthritis&#xD;
  &#xD;
            -  massive glenoid medialization&#xD;
  &#xD;
            -  Able to read or write Norwegian&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe osteoporosis&#xD;
  &#xD;
            -  Osteonecrosis of the humeral head&#xD;
  &#xD;
            -  Dementia&#xD;
  &#xD;
            -  Poor deltoid function&#xD;
  &#xD;
            -  Revision surgery&#xD;
  &#xD;
            -  ASA IV&#xD;
  &#xD;
            -  Suspected chronic infection&#xD;
  &#xD;
            -  Acute fracture&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sigbjørn Dimmen, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Oslo</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kjersti Kaul Jenssen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lovisenberg Diaconal Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Christian Owesen, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Lovisenberg Diaconal Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christian Owesen, PhD</last_name>
      <phone>+4790515843</phone>
      <email>cow@lds.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hanne Fuglø, MPTh</last_name>
      <phone>+4790524172</phone>
      <email>hanne.fuglo@lds.no</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Reverse shoulder arthroplasty</keyword>
    <keyword>BIO-RSA</keyword>
    <keyword>MIO-RSA</keyword>
    <keyword>Bony lateralization</keyword>
    <keyword>Metallic lateralization</keyword>
    <keyword>Orthopedic Surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025448
  org study id: CARS-2
  nct id: NCT06025448
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial will investigate whether metallic lateralization in reverse shoulder
        arthroplasty is as stable as bony lateralization during the first two postsurgical years,
        measured with CT-based motion analysis (CTMA).
  Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such
        as limited range of motion (ROM), and scapular notching, where the lower part of the scapular
        neck becomes eroded due to impingement against the humeral component. There's several ways to
        lateralize the glenoid component, a bone transplant placed underneath the glenoid component
        (Bony Increased Offset Reversed Shoulder Arthroplasty: BIO-RSA) has been used for some time.
        Recently glenoid components with metallic lateralization of the joint centre (Metal-Increased
        Offset Reversed Shoulder Arthroplasty: MIO-RSA) have been introduced, but there is not much
        comparative literature on metal vs. bony lateralization.
  
        Patients with osteoarthritis and medialization of the glenoid articular surface, who willing
        to participate in a study will be randomized to receive either MIO-RSA or a BIO-RSA. CT-based
        motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the
        glenoid components to assess the stability of the prostheses up to two years after
        implantation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Participants and health personnel examining the participants will be blinded. It will not be possible to blind the surgeons due to the nature of the intervention.
  measure: Migration of glenoid component from baseline until 24 months
  time frame: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.
  description: CT-based motion analysis (CTMA) will be used to measure the 3-dimensional migration pattern of the glenoid components to assess the stability of the prostheses up to two years after implantation.
  The motion analysis includes measurement of translation along three orthogonal axes and rotations around two orthogonal axes. CTMA is a marker-free motion analysis, and the images are obtained on a standard CT-machine. Analysis and computation of motion data are performed using proprietary software at Sectra AB (collaborating partner)
  CTMA is a relative new method to measure implant migration. The precision of the measurements is 0.08-0.15 mm for translation and 0.23-0.54º for rotation, therefore, CTMA is capable of measuring very small movements of the implant relative to the surrounding bone.
  measure: Change in WOOS Index
  time frame: Before randomization, 3, 12 and 24 months postoperatively.
  description: The Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis.
  There are 19 questions divided into four domains: Physical symptoms, sports and work, lifestyle and emotions. Each question is answered on a visual analogue scale ranging from 0 to 100. The overall score ranges from 0 to 1900, with 1900 being the worst. For ease of interpretation, the scores are often converted to a percentage of the maximum score.
  measure: Change in Constant-Murley Score
  time frame: Before randomization, 3, 12 and 24 months postoperatively.
  description: The 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. The test is divided into subjective and objective components. Two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65.
  Pain and ADL are answered by the patient; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.
  measure: Change in EuroQol-5
  time frame: Before randomization, 3, 12 and 24 months postoperatively.
  description: he widely used EuroQol-5 (EQ-5D-5L) will be used to measure health-related quality of life.
  The EQ5D-5L consists of two parts: A descriptive system (Mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-VAS that record patients self-rated health on a visual analog scale that range from 0 -100, higher levels indicate better self-rated health.
  The descriptive system can be converted to a single summary index number where lower levels indicate poorer health related quality of life.
  measure: Change in range of motion
  time frame: Before randomization, 3, 12 and 24 months postoperatively.
  description: The patient's active and passive range of motion (ROM) in the affected shoulder will be measured by an experienced physiotherapist with a long-legged goniometer. The directions measured will be flexion, abduction, external rotation and internal rotation, measured in degrees and/or physical landmarks.
  measure: Change in Subjective Shoulder Value
  time frame: Before randomization, 3, 12 and 24 months postoperatively.
  description: The SSV score is defined as the subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.
  measure: Anchor Question 1
  time frame: Before randomization, 3, 12 and 24 months postoperatively.
  description: This anchor question is asked to help determine Patient Acceptable Symptom State (PASS).
  "Considering all daily activities that involves your operated shoulder, your level of pain and degree of function, how satisfied are you with the condition of your shoulder is right now?" Alternatives: Satisfied/somewhat satisfied/Neither satisfied or unsatisfied/somewhat unsatisfied/Unsatisfied
  measure: Anchor Question 2
  time frame: 3, 12 and 24 months postoperatively
  description: This anchor question is asked to help determine Minimal Important Difference (MID) and Substantial Clinical Benefit (SCB).
  "Think of all the ways your operated shoulder has affected you the last week. Since your surgery, has there been any change in the condition of your shoulder that you would consider important or meaningful to you?" Alternatives: Much better/moderately better/a bit better/no change/a bit worse/moderately worse/Much worse
  arm group label: BIO-RSA
  arm group type: Active Comparator
  arm group label: MIO-RSA
  arm group type: Experimental
  intervention type: Procedure
  intervention name: BIO-RSA
  description: Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA).
  arm group label: BIO-RSA
  intervention type: Procedure
  intervention name: MIO-RSA
  description: Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA).
  arm group label: MIO-RSA
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Sigbjørn Dimmen, Prof.
  role: Principal Investigator
  affiliation: University of Oslo
  last name: Kjersti Kaul Jenssen, PhD
  role: Principal Investigator
  affiliation: Lovisenberg Diaconal Hospital
  last name: Christian Owesen, PhD
  role: Study Director
  affiliation: Lovisenberg Diaconal Hospital
  last name: Christian Owesen, PhD
  phone: +4790515843
  email: cow@lds.no
  last name: Hanne Fuglø, MPTh
  phone: +4790524172
  email: hanne.fuglo@lds.no
  responsible party type: Sponsor
  mesh term: Osteoarthritis