<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/NCT02998034</url>
  </required_header>
  <id_info>
    <org_study_id>13/WM/0049</org_study_id>
    <nct_id>NCT02998034</nct_id>
  </id_info>
  <brief_title>Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty</brief_title>
  <official_title>Randomised Controlled Trial of Cemented Hemiarthroplasty Versus Uncemented Furlong Hemiarthroplasty</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 9,000 people fracture their hip. Most of these are elderly females&#xD;
      with the fracture occurring after a fall. Approximately half of these fractures are&#xD;
      classified as intracapsular fractures because of their close proximity to the hip joint. The&#xD;
      majority of these fractures are treated surgically by excising the broken femoral neck and&#xD;
      removing the femoral head (ball part of the hip joint) and replacing it with an artificial&#xD;
      hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed&#xD;
      a 'half hip replacement' in which only the ball part of the hip joint is replaced.&#xD;
&#xD;
      There are a number of different designs of hemiarthroplasty that may be used. Some of the&#xD;
      implants are fixed in place with bone cement whilst the rest are inserted as a press fit&#xD;
      without the bone cement. The early designs of implant were all press fit but these designs&#xD;
      have now been shown to be inferior to those implants that are fixed in place with bone&#xD;
      cement.&#xD;
&#xD;
      There are however a number of newer designs of implant that are coated with a substance&#xD;
      (hydroxyapatite) that encourage the bone to grow onto the implant to fix it into place. To&#xD;
      date these implants have only been compared to the cement fit implants in only one previous&#xD;
      study. This study found no notable difference between the two types of hemiarthroplasty. This&#xD;
      study aims to add to the research studies by comparing standard cement fit implant with a&#xD;
      hydroxyapatite coated press fit implant to assist in determining the optimum surgical&#xD;
      treatment for this common and disabling condition.&#xD;
&#xD;
      Both implants to be used in this study are still being used extensively within the United&#xD;
      Kingdom and worldwide to treat this fracture. The study is therefore using two different&#xD;
      implants within their recommended area of use, but in which there is uncertainty as to which&#xD;
      is the best implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a follow-on from our current randomised trials of different types of treatment for hip&#xD;
      fractures, we wish to undertake a prospective randomised trial to compare a modern cemented&#xD;
      hemiarthroplasty prosthesis with a modern hydroxyapatite coated uncemented arthroplasty.&#xD;
&#xD;
      Cemented Exeter monoblock hemiarthroplasty The Exeter stemmed total hip replacement is&#xD;
      considered one of foremost performing hip replacements in the world. The ETS (Exeter trauma&#xD;
      stem) is one such implant and costs around £200. The implant has modern instrumentation and&#xD;
      the stem has proven long term survival rates when used for total hip replacement.&#xD;
&#xD;
      Hyroxyapatite coated prosthesis Coating a hip prosthesis with hydroxyapatite is common&#xD;
      practice for an uncemented hip replacement arthroplasty. The hydroxyapatite stimulates bone&#xD;
      ingrowth around the prosthesis and is this is thought to reduce loosening of the implant,&#xD;
      residual pain and the long-term revision rate.&#xD;
&#xD;
      The aim of the study is to assist in defining the optimum choice of arthroplasty for an acute&#xD;
      hip fracture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">June 2018</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</measure>
    <time_frame>assessed at one year from injury</time_frame>
    <description>measurement with a mobility score - Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med 2008;40:589-91.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Cemented monoblock hemiarthroplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The cemented monoblock hemiarthroplasty is a double tapered polished stem with a hemiarthroplasty head cemented in place (Zimmer incorporated, UK)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyroxyapatite coated prosthesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the Furlong Hyroxyapatite coated prosthesis (JRI orthopaedics limited UK) is a hydroxyapatite coating uncemented a hip prosthesis with a hemiarthroplasty head. The implant is uncemented.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Uncemented Furlong Hemiarthroplasty</intervention_name>
    <description>A furlong uncemeneted hyroxyapatite coated prosthesis.The hydroxyapatite stimulates bone ingrowth around the prosthesis and is this is thought to reduce loosening of the implant, residual pain and the long-term revision rate.</description>
    <arm_group_label>Hyroxyapatite coated prosthesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cemented tapered stem hemiarthroplasty</intervention_name>
    <description>A cemented double tapered stem hemiarthroplasty</description>
    <arm_group_label>Cemented monoblock hemiarthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to Peterborough City Hospital with a displaced intracapsular&#xD;
             fracture will be considered for inclusion in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Younger patients in which internal fixation is felt to be the choice of treatment to&#xD;
             preserve the femoral head. This is generally those aged less than 60 years in which&#xD;
             these patient have an expected good long term survival and are all treated by&#xD;
             reduction and internal fixation.&#xD;
&#xD;
               -  All other patients in whom the injury is to be treated by reduction and internal&#xD;
                  fixation for a specific indication.&#xD;
&#xD;
               -  Those patients who are able to walk independently out of doors with no more than&#xD;
                  the use of a stick and are not cognitively impaired. These patients will first be&#xD;
                  considered for the ongoing randomised trial of Hemiarthroplasty or Total hip&#xD;
                  replacement (R&amp;D reference - R&amp;D/2012/30, REC reference - 12/LO/15490)&#xD;
&#xD;
               -  Patients who decline to participate.&#xD;
&#xD;
               -  Patients admitted when MJP is not available to supervise treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Parker MJ, Cawley S. Cemented or uncemented hemiarthroplasty for displaced intracapsular fractures of the hip: a randomized trial of 400 patients. Bone Joint J. 2020 Jan;102-B(1):11-16. doi: 10.1302/0301-620X.102B1.BJJ-2019-1041.R1.</citation>
    <PMID>31888358</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no IPD will be generated</ipd_description>
  </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/NCT02998034
org study id: 13/WM/0049
nct id: NCT02998034
lead sponsor: 
has dmc: No
In England each year over 9,000 people fracture their hip. Most of these are elderly females
      with the fracture occurring after a fall. Approximately half of these fractures are
      classified as intracapsular fractures because of their close proximity to the hip joint. The
      majority of these fractures are treated surgically by excising the broken femoral neck and
      removing the femoral head (ball part of the hip joint) and replacing it with an artificial
      hip joint. This hip replacement has traditionally been a hemiarthroplasty or sometimes termed
      a 'half hip replacement' in which only the ball part of the hip joint is replaced.

      There are a number of different designs of hemiarthroplasty that may be used. Some of the
      implants are fixed in place with bone cement whilst the rest are inserted as a press fit
      without the bone cement. The early designs of implant were all press fit but these designs
      have now been shown to be inferior to those implants that are fixed in place with bone
      cement.

      There are however a number of newer designs of implant that are coated with a substance
      (hydroxyapatite) that encourage the bone to grow onto the implant to fix it into place. To
      date these implants have only been compared to the cement fit implants in only one previous
      study. This study found no notable difference between the two types of hemiarthroplasty. This
      study aims to add to the research studies by comparing standard cement fit implant with a
      hydroxyapatite coated press fit implant to assist in determining the optimum surgical
      treatment for this common and disabling condition.

      Both implants to be used in this study are still being used extensively within the United
      Kingdom and worldwide to treat this fracture. The study is therefore using two different
      implants within their recommended area of use, but in which there is uncertainty as to which
      is the best implant.
As a follow-on from our current randomised trials of different types of treatment for hip
      fractures, we wish to undertake a prospective randomised trial to compare a modern cemented
      hemiarthroplasty prosthesis with a modern hydroxyapatite coated uncemented arthroplasty.

      Cemented Exeter monoblock hemiarthroplasty The Exeter stemmed total hip replacement is
      considered one of foremost performing hip replacements in the world. The ETS (Exeter trauma
      stem) is one such implant and costs around £200. The implant has modern instrumentation and
      the stem has proven long term survival rates when used for total hip replacement.

      Hyroxyapatite coated prosthesis Coating a hip prosthesis with hydroxyapatite is common
      practice for an uncemented hip replacement arthroplasty. The hydroxyapatite stimulates bone
      ingrowth around the prosthesis and is this is thought to reduce loosening of the implant,
      residual pain and the long-term revision rate.

      The aim of the study is to assist in defining the optimum choice of arthroplasty for an acute
      hip fracture.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: regain of mobility
time frame: assessed at one year from injury
description: measurement with a mobility score - Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med 2008;40:589-91.
arm group label: Cemented monoblock hemiarthroplasty
arm group type: Experimental
description: The cemented monoblock hemiarthroplasty is a double tapered polished stem with a hemiarthroplasty head cemented in place (Zimmer incorporated, UK)
arm group label: Hyroxyapatite coated prosthesis
arm group type: Experimental
description: the Furlong Hyroxyapatite coated prosthesis (JRI orthopaedics limited UK) is a hydroxyapatite coating uncemented a hip prosthesis with a hemiarthroplasty head. The implant is uncemented.
intervention type: Device
intervention name: Uncemented Furlong Hemiarthroplasty
description: A furlong uncemeneted hyroxyapatite coated prosthesis.The hydroxyapatite stimulates bone ingrowth around the prosthesis and is this is thought to reduce loosening of the implant, residual pain and the long-term revision rate.
arm group label: Hyroxyapatite coated prosthesis
intervention type: Device
intervention name: Cemented tapered stem hemiarthroplasty
description: A cemented double tapered stem hemiarthroplasty
arm group label: Cemented monoblock hemiarthroplasty
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
citation: Parker MJ, Cawley S. Cemented or uncemented hemiarthroplasty for displaced intracapsular fractures of the hip: a randomized trial of 400 patients. Bone Joint J. 2020 Jan;102-B(1):11-16. doi: 10.1302/0301-620X.102B1.BJJ-2019-1041.R1.
PMID: 31888358
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: Hip Fractures
sharing ipd: No
ipd description: no IPD will be generated