<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/NCT03790267</url>
  </required_header>
  <id_info>
    <org_study_id>PaRIS-IOR</org_study_id>
    <nct_id>NCT03790267</nct_id>
  </id_info>
  <brief_title>Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty</brief_title>
  <acronym>PaRIS-IOR</acronym>
  <official_title>Functional Outcomes and Quality of Life Reported by Adult Patients Undergoing Elective Hip, Knee and Shoulder Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Rizzoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Ortopedico Rizzoli</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>
      PaRIS-IOR is a prospective observational study that aims to collect and analyze functional&#xD;
      outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder&#xD;
      arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PaRIS-IOR is a prospective observational study that aims to collect and analyze functional&#xD;
      outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder&#xD;
      arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR). IOR was selected as a pilot&#xD;
      center for the launch of the OECD's PaRIS Initiative in Italy, whose purpose is to accelerate&#xD;
      the adoption and reporting of validated, standardised, internationally-comparable&#xD;
      patient-reported indicators, particularly within patient registries.&#xD;
&#xD;
      PaRIS-IOR's study population will consist of consecutive patients undergoing hip, knee and&#xD;
      shoulder arthroplasty performed at 6 Operative Units of the IOR. The study will last 30&#xD;
      months and will include a 12-month recruitment period, a 12-month follow-up and 6 months for&#xD;
      data analysis and reporting. Functional outcomes and quality of life will be detected through&#xD;
      the administration of validated questionnaires (EQ-5D, HOOS, KOOS, ASES). The questionnaires&#xD;
      will be administered in the month preceding the surgical procedure in the clinic or in the&#xD;
      ward, while the 2 follow-up questionnaires will be send by mail at patients' home. The&#xD;
      collected data will be combined with those routinely collected by the Registry of Orthopedic&#xD;
      Prosthetic Implantology (RIPO), already active at the IOR since year 1990.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Functional outcomes: total score of the joint-specific functional scales.</measure>
    <time_frame>Baseline</time_frame>
    <description>The joint-specific functional scales derive from the following validated questionnaires: Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement; Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement; the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants. For all questionnaires the items are coded from 0 to 4, no functional difficulty to extreme functional difficulty respectively. The total score of the questionnaires can go from 0 (worst outcome) to 100 (best outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional outcomes: total score of the joint-specific functional scales.</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>The joint-specific functional scales derive from the following validated questionnaires: Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement; Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement; the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants. For all questionnaires the items are coded from 0 to 4, no functional difficulty to extreme functional difficulty respectively. The total score of the questionnaires can go from 0 (worst outcome) to 100 (best outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional outcomes: total score of the joint-specific functional scales.</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>The joint-specific functional scales derive from the following validated questionnaires: Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement; Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement; the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants. For all questionnaires the items are coded from 0 to 4, no functional difficulty to extreme functional difficulty respectively. The total score of the questionnaires can go from 0 (worst outcome) to 100 (best outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Euro-Quality-5-Dimensions questionnaire scores.</measure>
    <time_frame>Baseline</time_frame>
    <description>Euro Quality 5 Dimensions, EQ-5D, will be used for the general assessment of patient's health status. The EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents are asked to choose one of the statements which best describes their health status of surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Euro-Quality-5-Dimensions questionnaire scores.</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Euro Quality 5 Dimensions, EQ-5D, will be used for the general assessment of patient's health status. The EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents are asked to choose one of the statements which best describes their health status of surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Euro-Quality-5-Dimensions questionnaire scores.</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Euro Quality 5 Dimensions, EQ-5D, will be used for the general assessment of patient's health status. The EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents are asked to choose one of the statements which best describes their health status of surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analogue scale (EQ-VAS) scores</measure>
    <time_frame>Baseline</time_frame>
    <description>The respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100: (0) corresponds to &quot; the worst health you can imagine&quot;, and (100) corresponds to &quot;the best health you can imagine&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analogue scale (EQ-VAS) scores</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>The respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100: (0) corresponds to &quot; the worst health you can imagine&quot;, and (100) corresponds to &quot;the best health you can imagine&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analogue scale (EQ-VAS) scores</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>The respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100: (0) corresponds to &quot; the worst health you can imagine&quot;, and (100) corresponds to &quot;the best health you can imagine&quot;.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1700</enrollment>
  <condition>Arthroplasty, Replacement, Hip</condition>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <condition>Arthroplasty, Replacement, Shoulder</condition>
  <arm_group>
    <arm_group_label>Hip arthroplasty</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Knee arthroplasty</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Shoulder arthroplasty</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire administration</intervention_name>
    <description>One questionnaire (Euro Quality 5 Dimensions, EQ-5D) for the general assessment of patient's health status will be administered to all the patients in the study. One joint-specific questionnaires will be administered to patients depending on the surgery procedure they will be undergoing. Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement (6); Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement (7); the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants.</description>
    <arm_group_label>Hip arthroplasty</arm_group_label>
    <arm_group_label>Knee arthroplasty</arm_group_label>
    <arm_group_label>Shoulder arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of consecutive patients undergoing hip, knee and shoulder&#xD;
        arthroplasty. Patients will be enrolled at 6 operative units of the IOR (Orthopedic and&#xD;
        Traumatological I Clinic, Orthopedic and Traumatological Clinic II, Orthopedic and&#xD;
        Traumatologic Clinic III, Reconstructive Orthopedic Surgery - Innovative Techniques /&#xD;
        Revision surgery of hip prosthesis and new implant development, Surgery of the Shoulder and&#xD;
        Elbow, Orthopedics-Traumatology and Prosthetic Surgery and of hip and knee replanting). For&#xD;
        patients accessing through the &quot;hospitalization-before-surgery&quot; pathway, the enrollment&#xD;
        will take place in the specific ambulatory in the month preceding the intervention. The&#xD;
        remaining patients will be enrolled directly at the operative Units involved.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females aged 18-95 years&#xD;
&#xD;
          2. Be on the list for an elective primary arthroplasty of hip, knee or shoulder&#xD;
&#xD;
          3. Availability to sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe cognitive impairment&#xD;
&#xD;
          2. To be listed for arthroplasty for musculoskeletal cancer&#xD;
&#xD;
          3. Not eligible for the surgical intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Stefano Zaffagnini, MD</last_name>
    <phone>+39 0516366520</phone>
    <email>stefano.zaffagnini@unibo.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Susanna Stea, PhD</last_name>
    <email>susanna.stea@ior.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>January 12, 2019</last_update_submitted>
  <last_update_submitted_qc>January 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Ortopedico Rizzoli</investigator_affiliation>
    <investigator_full_name>Stefano Zaffagnini</investigator_full_name>
    <investigator_title>Full Professor of Orthopaedics</investigator_title>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03790267/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03790267
org study id: PaRIS-IOR
nct id: NCT03790267
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
PaRIS-IOR is a prospective observational study that aims to collect and analyze functional
      outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder
      arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR).
PaRIS-IOR is a prospective observational study that aims to collect and analyze functional
      outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder
      arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR). IOR was selected as a pilot
      center for the launch of the OECD's PaRIS Initiative in Italy, whose purpose is to accelerate
      the adoption and reporting of validated, standardised, internationally-comparable
      patient-reported indicators, particularly within patient registries.

      PaRIS-IOR's study population will consist of consecutive patients undergoing hip, knee and
      shoulder arthroplasty performed at 6 Operative Units of the IOR. The study will last 30
      months and will include a 12-month recruitment period, a 12-month follow-up and 6 months for
      data analysis and reporting. Functional outcomes and quality of life will be detected through
      the administration of validated questionnaires (EQ-5D, HOOS, KOOS, ASES). The questionnaires
      will be administered in the month preceding the surgical procedure in the clinic or in the
      ward, while the 2 follow-up questionnaires will be send by mail at patients' home. The
      collected data will be combined with those routinely collected by the Registry of Orthopedic
      Prosthetic Implantology (RIPO), already active at the IOR since year 1990.
observational model: Cohort
time perspective: Prospective
measure: Functional outcomes: total score of the joint-specific functional scales.
time frame: Baseline
description: The joint-specific functional scales derive from the following validated questionnaires: Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement; Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement; the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants. For all questionnaires the items are coded from 0 to 4, no functional difficulty to extreme functional difficulty respectively. The total score of the questionnaires can go from 0 (worst outcome) to 100 (best outcome).
measure: Functional outcomes: total score of the joint-specific functional scales.
time frame: 6 months after surgery
description: The joint-specific functional scales derive from the following validated questionnaires: Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement; Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement; the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants. For all questionnaires the items are coded from 0 to 4, no functional difficulty to extreme functional difficulty respectively. The total score of the questionnaires can go from 0 (worst outcome) to 100 (best outcome).
measure: Functional outcomes: total score of the joint-specific functional scales.
time frame: 12 months after surgery
description: The joint-specific functional scales derive from the following validated questionnaires: Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement; Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement; the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants. For all questionnaires the items are coded from 0 to 4, no functional difficulty to extreme functional difficulty respectively. The total score of the questionnaires can go from 0 (worst outcome) to 100 (best outcome).
measure: Euro-Quality-5-Dimensions questionnaire scores.
time frame: Baseline
description: Euro Quality 5 Dimensions, EQ-5D, will be used for the general assessment of patient's health status. The EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents are asked to choose one of the statements which best describes their health status of surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
measure: Euro-Quality-5-Dimensions questionnaire scores.
time frame: 6 months after surgery
description: Euro Quality 5 Dimensions, EQ-5D, will be used for the general assessment of patient's health status. The EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents are asked to choose one of the statements which best describes their health status of surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
measure: Euro-Quality-5-Dimensions questionnaire scores.
time frame: 12 months after surgery
description: Euro Quality 5 Dimensions, EQ-5D, will be used for the general assessment of patient's health status. The EQ-5D is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents are asked to choose one of the statements which best describes their health status of surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
measure: Visual analogue scale (EQ-VAS) scores
time frame: Baseline
description: The respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100: (0) corresponds to " the worst health you can imagine", and (100) corresponds to "the best health you can imagine".
measure: Visual analogue scale (EQ-VAS) scores
time frame: 6 months after surgery
description: The respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100: (0) corresponds to " the worst health you can imagine", and (100) corresponds to "the best health you can imagine".
measure: Visual analogue scale (EQ-VAS) scores
time frame: 12 months after surgery
description: The respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100: (0) corresponds to " the worst health you can imagine", and (100) corresponds to "the best health you can imagine".
arm group label: Hip arthroplasty
arm group label: Knee arthroplasty
arm group label: Shoulder arthroplasty
intervention type: Other
intervention name: Questionnaire administration
description: One questionnaire (Euro Quality 5 Dimensions, EQ-5D) for the general assessment of patient's health status will be administered to all the patients in the study. One joint-specific questionnaires will be administered to patients depending on the surgery procedure they will be undergoing. Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement (6); Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement (7); the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants.
arm group label: Hip arthroplasty
arm group label: Knee arthroplasty
arm group label: Shoulder arthroplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Stefano Zaffagnini, MD
phone: +39 0516366520
email: stefano.zaffagnini@unibo.it
last name: Susanna Stea, PhD
email: susanna.stea@ior.it
facility: 
status: Recruiting
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto Ortopedico Rizzoli
investigator full name: Stefano Zaffagnini
investigator title: Full Professor of Orthopaedics
provided document: 