<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/NCT03257709</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 184490</org_study_id>
    <nct_id>NCT03257709</nct_id>
  </id_info>
  <brief_title>The Arthroscopic Labral Excision or Repair Trial (ALERT)</brief_title>
  <acronym>ALERT</acronym>
  <official_title>The Arthroscopic Labral Excision or Repair Trial (ALERT) - A Randomised Controlled Trial to Determine the Effectiveness of Arthroscopic Hip Labral Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arthritis Research UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Royal College of Surgeons of England</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares two established surgical treatments for acetabular labral tears. Patients&#xD;
      will be prospectively recruited and randomised to either labral repair or debridement. All&#xD;
      patients will be followed for 2 years after intervention with a primary outcome assessment at&#xD;
      6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY DESIGN&#xD;
&#xD;
      Study design This will be a two-arm randomised controlled parallel group superiority study&#xD;
      and will take place in a hospital setting. Stratification will be performed for sex and age&#xD;
      by means of a minimisation technique during randomisation for each subject entering the&#xD;
      trial.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Adults between 18 and 75 years of age diagnosed with symptomatic acetabular labral tears&#xD;
      demonstrated on MRI arthrogram but without radiographic evidence of OA ie: Kellgren &amp;&#xD;
      Lawrence grade less than 2 randomly selected from the Nuffield Orthopaedic Centre outpatient&#xD;
      clinics.&#xD;
&#xD;
      Arm 1 Arthroscopic acetabular labral repair.&#xD;
&#xD;
      Arm 2 Arthroscopic acetabular labral resection&#xD;
&#xD;
      48 patients per arm (total 96 patients) will be selected from outpatient clinics and the&#xD;
      operative waiting list (pre-operative assessment clinics) at the Nuffield Orthopaedic Centre,&#xD;
      Oxford. The surgeries will be conducted using routine instrumentation in use at the centre.&#xD;
&#xD;
      STUDY PROCEDURES&#xD;
&#xD;
      Recruitment&#xD;
&#xD;
      All patients will undergo surgery in accordance with established practice regardless of their&#xD;
      treatment allocation. Arthroscopy will be performed using standard anterior and lateral&#xD;
      portals for insertion of instruments. All patients will undergo arthroscopic evaluation of&#xD;
      the entire joint. Subsequent procedures will vary according to treatment allocation:&#xD;
&#xD;
        -  Arm 1 - Labral Repair - acetabular labral tear will be identified and reattached using&#xD;
           suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a&#xD;
           cam or pincer lesion is identified then this will be treated with osteochondroplasty&#xD;
           (cam) or acetabular rim recession (pincer).&#xD;
&#xD;
        -  Arm 2 - Labral Resection - the acetabular labral tear will be identified and its' limits&#xD;
           defined. The torn portion of labrum will be resected to a stable edge. As with arm 1&#xD;
           there will be treatment of FAI if identified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hip Outcome Score</measure>
    <time_frame>6 Months Post Intervention</time_frame>
    <description>Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hip Outcome Scores (HOS)</measure>
    <time_frame>12, 18 &amp; 24 months post intervention</time_frame>
    <description>Hip Outcome Score at 12, 18 and 24 months post-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiologic MRI</measure>
    <time_frame>6 Months Post Intervention</time_frame>
    <description>T2 relaxation time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>X Ray</measure>
    <time_frame>6 Months Post Intervention</time_frame>
    <description>Joint space width</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>X Ray</measure>
    <time_frame>6 Months Post Intervention</time_frame>
    <description>Kellgren-Lawrence score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of Osteo Arthritis (OA)</measure>
    <time_frame>At surgery and 6, 12 &amp; 24 months post intervention.</time_frame>
    <description>Biomarkers of OA from synovial fluid and serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Assessment of Function</measure>
    <time_frame>6, 12 &amp; 24 months post intervention.</time_frame>
    <description>Clinical assessment of range of motion and impingement tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Economics</measure>
    <time_frame>6, 12, 18 &amp; 24 months post intervention</time_frame>
    <description>Assessment of economic burden associated with disease using EQ5D score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiologic MRI</measure>
    <time_frame>6 Months Post Intervention</time_frame>
    <description>T1 Rho</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Acetabular Labrum Tear</condition>
  <arm_group>
    <arm_group_label>Arthroscopic acetabular labral repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arthroscopic acetabular labral resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic acetabular labral repair</intervention_name>
    <description>Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).</description>
    <arm_group_label>Arthroscopic acetabular labral repair</arm_group_label>
    <other_name>Labral Repair</other_name>
    <other_name>Labral Reconstruction</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic acetabular labral resection</intervention_name>
    <description>The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.</description>
    <arm_group_label>Arthroscopic acetabular labral resection</arm_group_label>
    <other_name>Labral Resection</other_name>
    <other_name>Labral Debridement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to give informed consent for participation in the study.&#xD;
&#xD;
          -  Male or Female, aged between 18 and 75 years.&#xD;
&#xD;
          -  Symptomatic labral tear with evidence of labral tear on MRI.&#xD;
&#xD;
          -  No radiographic evidence of OA (Kellgren-Lawrence Grade &lt; 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous ipsilateral hip surgery&#xD;
&#xD;
          -  Irreparable labral tear&#xD;
&#xD;
          -  Previous fracture of femoral neck or acetabulum&#xD;
&#xD;
          -  Female patient who is pregnant&#xD;
&#xD;
          -  Established osteoarthritis (Kellgren-Lawrence ≥ 2)&#xD;
&#xD;
          -  Hip dysplasia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sion Glyn-Jones</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joanna S Burchall</last_name>
    <phone>01865737694</phone>
    <email>joanna.burchall@ndorms.ox.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>John AJ Broomfield</last_name>
    <phone>01865737694</phone>
    <email>john.broomfield@ndorms.ox.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nuffield Orthopaedic Centre, Oxford University Hospitals Trust</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanna Burchall</last_name>
      <phone>01865737694</phone>
      <email>joanna.burchall@ndorms.px.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>John Broomfield</last_name>
      <phone>01865737694</phone>
      <email>john.broomfield@ndorms.ox.ac.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Sion Glyn-Jones</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03257709
org study id: IRAS 184490
nct id: NCT03257709
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study compares two established surgical treatments for acetabular labral tears. Patients
      will be prospectively recruited and randomised to either labral repair or debridement. All
      patients will be followed for 2 years after intervention with a primary outcome assessment at
      6 months.
STUDY DESIGN

      Study design This will be a two-arm randomised controlled parallel group superiority study
      and will take place in a hospital setting. Stratification will be performed for sex and age
      by means of a minimisation technique during randomisation for each subject entering the
      trial.

      Study population:

      Adults between 18 and 75 years of age diagnosed with symptomatic acetabular labral tears
      demonstrated on MRI arthrogram but without radiographic evidence of OA ie: Kellgren &
      Lawrence grade less than 2 randomly selected from the Nuffield Orthopaedic Centre outpatient
      clinics.

      Arm 1 Arthroscopic acetabular labral repair.

      Arm 2 Arthroscopic acetabular labral resection

      48 patients per arm (total 96 patients) will be selected from outpatient clinics and the
      operative waiting list (pre-operative assessment clinics) at the Nuffield Orthopaedic Centre,
      Oxford. The surgeries will be conducted using routine instrumentation in use at the centre.

      STUDY PROCEDURES

      Recruitment

      All patients will undergo surgery in accordance with established practice regardless of their
      treatment allocation. Arthroscopy will be performed using standard anterior and lateral
      portals for insertion of instruments. All patients will undergo arthroscopic evaluation of
      the entire joint. Subsequent procedures will vary according to treatment allocation:

        -  Arm 1 - Labral Repair - acetabular labral tear will be identified and reattached using
           suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a
           cam or pincer lesion is identified then this will be treated with osteochondroplasty
           (cam) or acetabular rim recession (pincer).

        -  Arm 2 - Labral Resection - the acetabular labral tear will be identified and its' limits
           defined. The torn portion of labrum will be resected to a stable edge. As with arm 1
           there will be treatment of FAI if identified.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Hip Outcome Score
time frame: 6 Months Post Intervention
description: Change in Hip Outcome Score (Activities of Daily Living Subscale) at 6 months post intervention from baseline.
measure: Hip Outcome Scores (HOS)
time frame: 12, 18 & 24 months post intervention
description: Hip Outcome Score at 12, 18 and 24 months post-operatively.
measure: Physiologic MRI
time frame: 6 Months Post Intervention
description: T2 relaxation time
measure: X Ray
time frame: 6 Months Post Intervention
description: Joint space width
measure: X Ray
time frame: 6 Months Post Intervention
description: Kellgren-Lawrence score
measure: Biomarkers of Osteo Arthritis (OA)
time frame: At surgery and 6, 12 & 24 months post intervention.
description: Biomarkers of OA from synovial fluid and serum.
measure: Clinical Assessment of Function
time frame: 6, 12 & 24 months post intervention.
description: Clinical assessment of range of motion and impingement tests.
measure: Health Economics
time frame: 6, 12, 18 & 24 months post intervention
description: Assessment of economic burden associated with disease using EQ5D score
measure: Physiologic MRI
time frame: 6 Months Post Intervention
description: T1 Rho
arm group label: Arthroscopic acetabular labral repair
arm group type: Active Comparator
description: Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
arm group label: Arthroscopic acetabular labral resection
arm group type: Active Comparator
description: The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.
intervention type: Procedure
intervention name: Arthroscopic acetabular labral repair
description: Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
arm group label: Arthroscopic acetabular labral repair
other name: Labral Repair
other name: Labral Reconstruction
intervention type: Procedure
intervention name: Arthroscopic acetabular labral resection
description: The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.
arm group label: Arthroscopic acetabular labral resection
other name: Labral Resection
other name: Labral Debridement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sion Glyn-Jones
role: Principal Investigator
affiliation: University of Oxford
last name: Joanna S Burchall
phone: 01865737694
email: joanna.burchall@ndorms.ox.ac.uk
last name: John AJ Broomfield
phone: 01865737694
email: john.broomfield@ndorms.ox.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No