<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/NCT03264196</url>
  </required_header>
  <id_info>
    <org_study_id>12513</org_study_id>
    <nct_id>NCT03264196</nct_id>
  </id_info>
  <brief_title>Condylar Head Operative or Conservative 1</brief_title>
  <acronym>CHOC1</acronym>
  <official_title>Condylar Head Operative or Conservative 1, Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oxford University Hospitals 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>
      The condylar head is the part of the lower jaw which forms the joint. Displaced fractures of&#xD;
      this area are uncommon but can cause problems with function, such as chewing, if not treated&#xD;
      effectively. The medical literature does not have a clear consensus on whether these should&#xD;
      be treated operatively (with surgery to reduce and fix the fracture) or conservatively (with&#xD;
      advice and exercise and no surgery). The investigators propose a randomised controlled trial&#xD;
      comparing the outcome of the operative or conservative treatment of condylar head fractures&#xD;
      of the mandible, primarily with regards to patient related outcome measures of mandibular&#xD;
      function, and secondarily objective measures of mandibular movement, function and symptoms to&#xD;
      try and provide a clearer answer as to the best way of managing them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current medical literature provides conflicting evidence as to the benefits of operative&#xD;
      or conservative management of displaced condylar head fractures. Whilst conservative&#xD;
      treatment has few risks in itself, most of the evidence would suggest that outcomes are not&#xD;
      quite as good as operative management. Operative treatment has complications that are not&#xD;
      presented by conservative treatment, such as the risk of infection or facial nerve injury and&#xD;
      therefore it is important to demonstrate that such treatment has sufficient benefits to merit&#xD;
      it's consideration, and to properly inform the patients about the benefits and risks of&#xD;
      treatment. When patients present with these injuries it is currently difficult to provide&#xD;
      them with good evidence for them to make an informed decision with, as to whether to undergo&#xD;
      surgery or not. At present the patient is expected to make a decision as to whether to have&#xD;
      surgery or not based on this limited knowledge, and it is the investigator's experience with&#xD;
      consulting these patients and the questions they asked that has demonstrated the need for and&#xD;
      guided the design of the trial focusing on a patient related outcome quality of life measure,&#xD;
      rather than the common objective measures.#&#xD;
&#xD;
      The main purpose of undertaking this RCT is to directly compare the results of operative and&#xD;
      conservative management focusing on an outcome which is determined by the patients perception&#xD;
      of their function and quality of life rather than purely objective measurements. A randomised&#xD;
      controlled trial would provide the strongest level of evidence to support future care&#xD;
      decisions and any patient with a unilateral fracture would be considered for inclusion if&#xD;
      they can give informed consent and are able to complete the PROM questionnaire at the&#xD;
      necessary time points. Exclusion criteria are limited, but include bilateral fractures&#xD;
      because these are less common and the results may not be directly comparable.&#xD;
&#xD;
      The trial design has been kept simple and adds no significant burden to patients as all&#xD;
      aspects of care and follow up are the same as the current standard of care apart from the&#xD;
      completion of the questionnaire, which can be completed relatively quickly during&#xD;
      participant's clinic appointments. The investigators are experienced surgeons in this field&#xD;
      and able to fully answer any questions from patients with regards to the trial, and to risks&#xD;
      and benefits of either treatment option. Neither has any conflict of interest in undertaking&#xD;
      the trial.&#xD;
&#xD;
      All trial data will be handled confidentially in line with good governance procedures, and&#xD;
      will be monitored by appropriate persons from the trial sponsors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 24, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</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>Randomised Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in functional self reported outcome measure</measure>
    <time_frame>12 months</time_frame>
    <description>Difference in function assessed using Mandibular Functional Impairment Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fracture Reduction</measure>
    <time_frame>12 months</time_frame>
    <description>Post operative fracture reduction (ramus / condyle height - fracture side compared to normal on post operative OPG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mouth Opening</measure>
    <time_frame>12 months</time_frame>
    <description>Mean interincisal opening- mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mandibular lateral movements</measure>
    <time_frame>12 months</time_frame>
    <description>Mean lateral excursion from affected side - mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mandibular protrusion</measure>
    <time_frame>12 months</time_frame>
    <description>Mean Protrusion - mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>12 months</time_frame>
    <description>Pain - linkart score (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary interference</measure>
    <time_frame>12 months</time_frame>
    <description>Dietary interference - linkart score (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mandibular functional impairment</measure>
    <time_frame>12 months</time_frame>
    <description>Functional impairment rating scale (1-4)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Condylar Process of Mandible Open Fracture</condition>
  <arm_group>
    <arm_group_label>Operative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open Reduction and Internal Fixation of Condylar Head Fracture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non-operatively managed Condylar Head Fracture</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Reduction and Internal Fixation</intervention_name>
    <description>Surgical treatment of fracture</description>
    <arm_group_label>Operative</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             trial.&#xD;
&#xD;
          -  Male or Female, aged 18 years or above.&#xD;
&#xD;
          -  Be in good health - suitable for general anaesthesia for surgical treatment&#xD;
&#xD;
          -  Willing to allow his or her General Practitioner and consultant, if appropriate, to be&#xD;
             notified of participation in the trial.&#xD;
&#xD;
          -  Unilateral condylar head fracture with or without other mandibular body or angle&#xD;
             fractures, or other maxillofacial injuries&#xD;
&#xD;
          -  Condylar head fracture displaced by at least 2 mm measured on coronal or sagittal CT&#xD;
             scan&#xD;
&#xD;
          -  In the Investigator's opinion, is able and willing to comply with all trial&#xD;
             requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undisplaced condylar head fractures, or displaced less than 2 mm on coronal or&#xD;
             sagittal CT&#xD;
&#xD;
          -  Bilateral condylar head fractures&#xD;
&#xD;
          -  Pre-existing congenital or acquired pathology of the ipsilateral or contralateral&#xD;
             temporomandibular joint - including but not limited to ankylosis, inflammatory&#xD;
             arthropathy, idiopathic condylar resorption&#xD;
&#xD;
          -  Pregnancy (increased risk of joint pain and laxity)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niall MH Mcleod, FRCS(OMFS)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oxford University Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Niall MH McLeod, FRCS(OMFS)</last_name>
    <phone>01865743102</phone>
    <email>niall.mcleod@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Gerber</last_name>
      <phone>+441865743101</phone>
      <email>barbara.gerber@ouh.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 14, 2022</last_update_submitted>
  <last_update_submitted_qc>September 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oxford University Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Niall Mcleod</investigator_full_name>
    <investigator_title>Consultant Oral and Maxillofacial Surgeon</investigator_title>
  </responsible_party>
  <keyword>condylar hear</keyword>
  <keyword>fracture</keyword>
  <keyword>randomised controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Open</mesh_term>
  </condition_browse>
  <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/NCT03264196
org study id: 12513
nct id: NCT03264196
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The condylar head is the part of the lower jaw which forms the joint. Displaced fractures of
      this area are uncommon but can cause problems with function, such as chewing, if not treated
      effectively. The medical literature does not have a clear consensus on whether these should
      be treated operatively (with surgery to reduce and fix the fracture) or conservatively (with
      advice and exercise and no surgery). The investigators propose a randomised controlled trial
      comparing the outcome of the operative or conservative treatment of condylar head fractures
      of the mandible, primarily with regards to patient related outcome measures of mandibular
      function, and secondarily objective measures of mandibular movement, function and symptoms to
      try and provide a clearer answer as to the best way of managing them.
The current medical literature provides conflicting evidence as to the benefits of operative
      or conservative management of displaced condylar head fractures. Whilst conservative
      treatment has few risks in itself, most of the evidence would suggest that outcomes are not
      quite as good as operative management. Operative treatment has complications that are not
      presented by conservative treatment, such as the risk of infection or facial nerve injury and
      therefore it is important to demonstrate that such treatment has sufficient benefits to merit
      it's consideration, and to properly inform the patients about the benefits and risks of
      treatment. When patients present with these injuries it is currently difficult to provide
      them with good evidence for them to make an informed decision with, as to whether to undergo
      surgery or not. At present the patient is expected to make a decision as to whether to have
      surgery or not based on this limited knowledge, and it is the investigator's experience with
      consulting these patients and the questions they asked that has demonstrated the need for and
      guided the design of the trial focusing on a patient related outcome quality of life measure,
      rather than the common objective measures.#

      The main purpose of undertaking this RCT is to directly compare the results of operative and
      conservative management focusing on an outcome which is determined by the patients perception
      of their function and quality of life rather than purely objective measurements. A randomised
      controlled trial would provide the strongest level of evidence to support future care
      decisions and any patient with a unilateral fracture would be considered for inclusion if
      they can give informed consent and are able to complete the PROM questionnaire at the
      necessary time points. Exclusion criteria are limited, but include bilateral fractures
      because these are less common and the results may not be directly comparable.

      The trial design has been kept simple and adds no significant burden to patients as all
      aspects of care and follow up are the same as the current standard of care apart from the
      completion of the questionnaire, which can be completed relatively quickly during
      participant's clinic appointments. The investigators are experienced surgeons in this field
      and able to fully answer any questions from patients with regards to the trial, and to risks
      and benefits of either treatment option. Neither has any conflict of interest in undertaking
      the trial.

      All trial data will be handled confidentially in line with good governance procedures, and
      will be monitored by appropriate persons from the trial sponsors.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised Controlled Trial
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in functional self reported outcome measure
time frame: 12 months
description: Difference in function assessed using Mandibular Functional Impairment Questionnaire
measure: Fracture Reduction
time frame: 12 months
description: Post operative fracture reduction (ramus / condyle height - fracture side compared to normal on post operative OPG)
measure: Mouth Opening
time frame: 12 months
description: Mean interincisal opening- mm
measure: Mandibular lateral movements
time frame: 12 months
description: Mean lateral excursion from affected side - mm
measure: Mandibular protrusion
time frame: 12 months
description: Mean Protrusion - mm
measure: Pain Score
time frame: 12 months
description: Pain - linkart score (0-10)
measure: Dietary interference
time frame: 12 months
description: Dietary interference - linkart score (0-10)
measure: Mandibular functional impairment
time frame: 12 months
description: Functional impairment rating scale (1-4)
arm group label: Operative
arm group type: Active Comparator
description: Open Reduction and Internal Fixation of Condylar Head Fracture
arm group label: Conservative
arm group type: No Intervention
description: Non-operatively managed Condylar Head Fracture
intervention type: Procedure
intervention name: Open Reduction and Internal Fixation
description: Surgical treatment of fracture
arm group label: Operative
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Niall MH Mcleod, FRCS(OMFS)
role: Principal Investigator
affiliation: Oxford University Hospitals
last name: Niall MH McLeod, FRCS(OMFS)
phone: 01865743102
email: niall.mcleod@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Oxford University Hospitals NHS Trust
investigator full name: Niall Mcleod
investigator title: Consultant Oral and Maxillofacial Surgeon
mesh term: Fractures, Open
sharing ipd: No