<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/NCT02996383</url>
  </required_header>
  <id_info>
    <org_study_id>R&amp;D/2016/05</org_study_id>
    <nct_id>NCT02996383</nct_id>
  </id_info>
  <brief_title>Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures</brief_title>
  <official_title>Fixation Versus Arthroplasty for Undisplaced Intracapsular Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peterborough and Stamford Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peterborough and Stamford Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In England each year over 70,000 people fracture their hip. Most of these patients are&#xD;
      elderly females with the fracture occurring after a simple trip or stumble. Approximately&#xD;
      half of these fractures are classified from their relationship to the hip joint capsule as&#xD;
      intracapsular. These fractures are subdivided into those that are displaced and those that&#xD;
      are undisplaced. The majority of displaced fractures are treated with a replacement&#xD;
      arthroplasty. Current treatment for the undisplaced fractures is generally by internal&#xD;
      fixation of the fracture using screws and a plate, although some centres prefer replacement&#xD;
      arthroplasty.&#xD;
&#xD;
      A recent randomised study on patients from Norway with undisplaced intracapsular fractures&#xD;
      treated with either internal fixation or arthroplasty has just reported reduced complications&#xD;
      and re-operations for those patients treated with an arthroplasty. In addition functional&#xD;
      results were marginally better for those patients treated with an arthroplasty. Current&#xD;
      practice in the UK is generally to treat these fractures by internal fixation. This study&#xD;
      aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the&#xD;
      Norwegian study.&#xD;
&#xD;
      Patients who satisfy the inclusion criteria and are willing to participate will be randomised&#xD;
      to receive either reduction and internal fixation of the fracture with a screw and plate&#xD;
      device or alternatively replacement of their femoral head with an artificial hip replacement&#xD;
      (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be&#xD;
      discharge home when able, with follow-up review in the hip fracture clinic. Subsequent&#xD;
      follow-up for the research project is by phone calls from a research nurse who is blinded to&#xD;
      the type of treatment that the patient has received. There will be no additional&#xD;
      investigations or out-patient follow-up visits for these patients in comparison to normal&#xD;
      treatment protocols. Results of the study will ultimately be published in a medical journal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <primary_completion_date type="Anticipated">September 2019</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>regain of mobility using the Parker and Palmer mobility scale</measure>
    <time_frame>one year</time_frame>
    <description>Assessment is using the Parker and Palmer mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993;75:797-8.)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Undisplaced Intracapsular Hip Fracture</condition>
  <arm_group>
    <arm_group_label>Cemented hemiarthroplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment of the fracture by a replacement arthroplasty with a cemented CPT hemiarthroplasty (manafactured by Zimmer company, Warsaw IN, USA) inserted via an anteriolateral approach to the hip</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Internal fixation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Internal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Internal fixation</intervention_name>
    <description>Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)</description>
    <arm_group_label>Internal fixation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cemented Hemiarthroplasty</intervention_name>
    <description>Replacement of the femoral head with a cemented hemiarthroplasty</description>
    <arm_group_label>Cemented hemiarthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to Peterborough and Stamford Hospitals NHS Foundation Trust with&#xD;
             an undisplaced intracapsular fracture will be considered for inclusion within the&#xD;
             study. Patients who lack Capacity for example dementia who are unable to provide&#xD;
             informed consent will be included if the assent of their next of kin or legal guardian&#xD;
             can be obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • patients who decline to participate or in whom consent or assent is not available&#xD;
&#xD;
               -  patients admitted when MJP is not available to supervise treatment&#xD;
&#xD;
               -  patients with pathological fractures from Paget's disease of bone secondary's&#xD;
                  from tumour&#xD;
&#xD;
               -  patients with delayed presentation who would be treated conservatively&#xD;
&#xD;
               -  patients considered unfit for either surgical procedure&#xD;
&#xD;
               -  younger patients, aged less than 80 years who are independently mobile and very&#xD;
                  active will be excluded at treated by internal fixation (the risk of fracture&#xD;
                  healing complication for this group is less, whilst there is an increased risk of&#xD;
                  long term complications after arthroplasty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>martyn parker</last_name>
    <phone>441733678000</phone>
    <email>martyn.parker@pbh-tr.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peterborough and Stamford Hospital NHS Foundation Trust</name>
      <address>
        <city>Peterborough</city>
        <state>Cambs</state>
        <zip>PE36DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martyn J Parker, MD</last_name>
      <phone>441733874000</phone>
      <phone_ext>4193</phone_ext>
      <email>Martyn.Parker@pbh-tr.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>June 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peterborough and Stamford Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Martyn J Parker</investigator_full_name>
    <investigator_title>consultant orthopaedic surgeon</investigator_title>
  </responsible_party>
  <keyword>arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <!-- 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/NCT02996383
org study id: R&D/2016/05
nct id: NCT02996383
lead sponsor: 
has dmc: No
In England each year over 70,000 people fracture their hip. Most of these patients are
      elderly females with the fracture occurring after a simple trip or stumble. Approximately
      half of these fractures are classified from their relationship to the hip joint capsule as
      intracapsular. These fractures are subdivided into those that are displaced and those that
      are undisplaced. The majority of displaced fractures are treated with a replacement
      arthroplasty. Current treatment for the undisplaced fractures is generally by internal
      fixation of the fracture using screws and a plate, although some centres prefer replacement
      arthroplasty.

      A recent randomised study on patients from Norway with undisplaced intracapsular fractures
      treated with either internal fixation or arthroplasty has just reported reduced complications
      and re-operations for those patients treated with an arthroplasty. In addition functional
      results were marginally better for those patients treated with an arthroplasty. Current
      practice in the UK is generally to treat these fractures by internal fixation. This study
      aims to see if replacement arthroplasty can indeed lead to the advantages suggested from the
      Norwegian study.

      Patients who satisfy the inclusion criteria and are willing to participate will be randomised
      to receive either reduction and internal fixation of the fracture with a screw and plate
      device or alternatively replacement of their femoral head with an artificial hip replacement
      (hemiarthroplasty). After surgery patients will receive the same treatment as normal and be
      discharge home when able, with follow-up review in the hip fracture clinic. Subsequent
      follow-up for the research project is by phone calls from a research nurse who is blinded to
      the type of treatment that the patient has received. There will be no additional
      investigations or out-patient follow-up visits for these patients in comparison to normal
      treatment protocols. Results of the study will ultimately be published in a medical journal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: regain of mobility using the Parker and Palmer mobility scale
time frame: one year
description: Assessment is using the Parker and Palmer mobility score (Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993;75:797-8.)
arm group label: Cemented hemiarthroplasty
arm group type: Active Comparator
description: Treatment of the fracture by a replacement arthroplasty with a cemented CPT hemiarthroplasty (manafactured by Zimmer company, Warsaw IN, USA) inserted via an anteriolateral approach to the hip
arm group label: Internal fixation
arm group type: Active Comparator
description: Internal fixation of the fracture with a screw and plate device (Targon FN plate, Aesculap cooperation, Tuttingham, Germany)
intervention type: Device
intervention name: Internal fixation
description: Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)
arm group label: Internal fixation
intervention type: Device
intervention name: Cemented Hemiarthroplasty
description: Replacement of the femoral head with a cemented hemiarthroplasty
arm group label: Cemented hemiarthroplasty
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: martyn parker
phone: 441733678000
email: martyn.parker@pbh-tr.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Peterborough and Stamford Hospitals NHS Foundation Trust
investigator full name: Martyn J Parker
investigator title: consultant orthopaedic surgeon
mesh term: Fractures, Bone
mesh term: Hip Fractures