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/NCT06037278</url>
    </required_header>
    <id_info>
      <org_study_id>ROH22ORTH13</org_study_id>
      <nct_id>NCT06037278</nct_id>
    </id_info>
    <brief_title>Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study</brief_title>
    <acronym>MyPAO</acronym>
    <official_title>MyPAO Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Royal Orthopaedic Hospital NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Royal Orthopaedic Hospital NHS Trust</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>
        A case series to provide post marketing evaluation of the MyPAO surgical planning and patient&#xD;
        specific guides technology. This will be a single-centre, multi-surgeon evaluation assessing&#xD;
        the safety of the use of these guides in periacetabular osteotomy surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After enrolment, baseline data will be collected including age, sex and ethnicity of the&#xD;
        participant. The radiographic measures of centre edge angle of Wiberg and acetabular&#xD;
        inclination will be measured by the surgeon and patient reported outcome measures (PROMS)&#xD;
        will be collected. The PROMS collected at usual care timepoints in patients undergoing pelvic&#xD;
        osteotomy will be collated for use in the dataset. Peri-operative data, including clinician&#xD;
        opinion on ease of use, intraoperative dose of radiation used and device associated adverse&#xD;
        events, will be recorded and reported in the results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Product safety assessment</measure>
      <time_frame>3 months post-surgery</time_frame>
      <description>evaluate the use of the MyPAOTM technology by reviewing number of device related adverse events, in order to continue to assess product safety as part of post marketing surveillance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proof of concept</measure>
      <time_frame>12 months</time_frame>
      <description>surgeon questionnaires after each case. We will determine technical difficulties in using the device, surgeon satisfaction with the use of guides and the guided correction and the presence of any intra-operative adverse events.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>i-hot12 questionnaire</measure>
      <time_frame>12 months post-surgery</time_frame>
      <description>hip-specific health related quality of life outcome tool</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Eq-5D</measure>
      <time_frame>12 months post-surgery</time_frame>
      <description>validated measure of health-related quality of life</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Pelvic Osteotomy</condition>
    <condition>Acetabular Dysplasia</condition>
    <condition>Periacetabular Osteotomy</condition>
    <arm_group>
      <arm_group_label>MyPAO use</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>SIngle arm study, use of device</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MyPAO</intervention_name>
      <description>use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia</description>
      <arm_group_label>MyPAO use</arm_group_label>
      <other_name>periacetabular osteotomy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  · Age greater than 18 years&#xD;
  &#xD;
                 -  Patient undergoing pelvic osteotomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  · Evidence of hip degeneration assessed by the surgeon on x-ray (Tonnis Grade 1 or&#xD;
               greater)&#xD;
  &#xD;
                 -  Known allergy to Polyamide PA12&#xD;
  &#xD;
                 -  Unable to provide written informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The Royal Orthopaedic Hospital NHS Trust</name>
        <address>
          <city>Birmingham</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gareth Mr Stephens, BSc</last_name>
        <phone>01216854316</phone>
        <email>gareth.stephens@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>sam papadopoullos, BSc</last_name>
        <phone>01216854316</phone>
        <email>sam.papadopoullos@nhs.net</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Customised surgical guides</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Developmental Dysplasia of the Hip</mesh_term>
      <mesh_term>Hip Dislocation, Congenital</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06037278
  org study id: ROH22ORTH13
  nct id: NCT06037278
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A case series to provide post marketing evaluation of the MyPAO surgical planning and patient
        specific guides technology. This will be a single-centre, multi-surgeon evaluation assessing
        the safety of the use of these guides in periacetabular osteotomy surgery.
  After enrolment, baseline data will be collected including age, sex and ethnicity of the
        participant. The radiographic measures of centre edge angle of Wiberg and acetabular
        inclination will be measured by the surgeon and patient reported outcome measures (PROMS)
        will be collected. The PROMS collected at usual care timepoints in patients undergoing pelvic
        osteotomy will be collated for use in the dataset. Peri-operative data, including clinician
        opinion on ease of use, intraoperative dose of radiation used and device associated adverse
        events, will be recorded and reported in the results.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Product safety assessment
  time frame: 3 months post-surgery
  description: evaluate the use of the MyPAOTM technology by reviewing number of device related adverse events, in order to continue to assess product safety as part of post marketing surveillance.
  measure: Proof of concept
  time frame: 12 months
  description: surgeon questionnaires after each case. We will determine technical difficulties in using the device, surgeon satisfaction with the use of guides and the guided correction and the presence of any intra-operative adverse events.
  measure: i-hot12 questionnaire
  time frame: 12 months post-surgery
  description: hip-specific health related quality of life outcome tool
  measure: Eq-5D
  time frame: 12 months post-surgery
  description: validated measure of health-related quality of life
  arm group label: MyPAO use
  arm group type: Other
  description: SIngle arm study, use of device
  intervention type: Device
  intervention name: MyPAO
  description: use of MyPAO surgical guide to support periacetabular osteotomy procedures for treatment of acetabular dysplasia
  arm group label: MyPAO use
  other name: periacetabular osteotomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Developmental Dysplasia of the Hip
  mesh term: Hip Dislocation, Congenital
  sharing ipd: No