<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/NCT02983526</url>
  </required_header>
  <id_info>
    <org_study_id>CFP-SUH</org_study_id>
    <nct_id>NCT02983526</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Study Comparing a Short Stem Hip Prosthesis With a Stem of Standard Length</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johan Karrholm</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis&#xD;
      were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden.&#xD;
      The patients were randomized to either CFP or Corail stem, both groups received Delta cup&#xD;
      from Lima. Randomisation was done using envelopes. Patients could only participate with one&#xD;
      hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The concept of femoral neck preserving hip replacement is intended for the young and active&#xD;
      patients. By preserving proximal bone load, the transmission to the proximal femur is&#xD;
      supposed to improve and future revision surgery would be facilitated. The hypothesis is that&#xD;
      a more conservative resection of the femoral neck could lead to better clinical outcomes&#xD;
      compared to a conventional stem. The clinical outcomes and the fixation of a short femoral&#xD;
      stem were therefore compared with a stem of standard length. 83 patients were included in our&#xD;
      randomized controlled trial where patients either received a Collum Femoris Preserving (CFP)&#xD;
      stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are&#xD;
      studied and the early migration is being measured using radiostereometric analysis. All of&#xD;
      the patients have gone through 1 year follow-up. The 2 years results will be available at the&#xD;
      end of 2017.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxford Hip Score</measure>
    <time_frame>Preoperatively to 2 years</time_frame>
    <description>The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. It is short, reproducible, valid and sensitive to clinically important changes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiostereometric analysis</measure>
    <time_frame>Preoperatively to 2 years</time_frame>
    <description>Radiostereometric analysis is an accurate method of determining the migration and wear of orthopaedic implants such as total hip arthroplasties. The overall concept of RSA is straightforward: determining the precise location of two distinct objects relative to each other in three dimension (such as the relative position of the femoral component and the proximal femur).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction (VAS), Pain (VAS)</measure>
    <time_frame>Preoperatively to 2 years</time_frame>
    <description>Patient satisfaction and pain are reported on visual analogue scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris hip score</measure>
    <time_frame>Preoperatively to 2 years</time_frame>
    <description>One of the oldest and most commonly used scores to assess function and pain with patients undergoing hip replacement surgery.</description>
  </secondary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Primary Osteoarthritis of Hip Nos</condition>
  <condition>Secondary Osteoarthritis of Hip</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total hip replacement (2 different designs)</intervention_name>
    <description>Patients will randomly receive either CFP or Corail stem</description>
    <other_name>CFP stem or Corail stem</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary osteoarthritis of hip&#xD;
&#xD;
          -  secondary osteoarthritis due to hip dysplasia or Perthes under condition that the&#xD;
             collum anatomy is well preserved and largely unaffected by the primary disease&#xD;
&#xD;
          -  avascular necrosis of femoral head&#xD;
&#xD;
          -  anatomy suitable for both designs according to preoperative planning&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous treatment with cortisone&#xD;
&#xD;
          -  generalized joint disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan Kärrholm, MD, PhD, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>April 7, 2017</last_update_submitted>
  <last_update_submitted_qc>April 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Johan Karrholm</investigator_full_name>
    <investigator_title>MD, Professor in Orthopaedics</investigator_title>
  </responsible_party>
  <keyword>short stem</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02983526
org study id: CFP-SUH
nct id: NCT02983526
lead sponsor: 
has dmc: No
80 patients eligible for a total hip replacement (THR) mainly due to primary osteoarthritis
      were recruited from the waiting list for hip arthroplasty at a university hospital in Sweden.
      The patients were randomized to either CFP or Corail stem, both groups received Delta cup
      from Lima. Randomisation was done using envelopes. Patients could only participate with one
      hip. Patients are evaluated with different questionnaires, radiographs and RSA analysis.
The concept of femoral neck preserving hip replacement is intended for the young and active
      patients. By preserving proximal bone load, the transmission to the proximal femur is
      supposed to improve and future revision surgery would be facilitated. The hypothesis is that
      a more conservative resection of the femoral neck could lead to better clinical outcomes
      compared to a conventional stem. The clinical outcomes and the fixation of a short femoral
      stem were therefore compared with a stem of standard length. 83 patients were included in our
      randomized controlled trial where patients either received a Collum Femoris Preserving (CFP)
      stem or a Corail hip stem. Clinical outcomes are being assessed, plain radiographs are
      studied and the early migration is being measured using radiostereometric analysis. All of
      the patients have gone through 1 year follow-up. The 2 years results will be available at the
      end of 2017.
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oxford Hip Score
time frame: Preoperatively to 2 years
description: The Oxford Hip Score (OHS) is a short 12-item patient-reported PRO specifically designed and developed to assess function and pain with patients undergoing hip replacement surgery. It is short, reproducible, valid and sensitive to clinically important changes.
measure: Radiostereometric analysis
time frame: Preoperatively to 2 years
description: Radiostereometric analysis is an accurate method of determining the migration and wear of orthopaedic implants such as total hip arthroplasties. The overall concept of RSA is straightforward: determining the precise location of two distinct objects relative to each other in three dimension (such as the relative position of the femoral component and the proximal femur).
measure: Patient satisfaction (VAS), Pain (VAS)
time frame: Preoperatively to 2 years
description: Patient satisfaction and pain are reported on visual analogue scales.
measure: Harris hip score
time frame: Preoperatively to 2 years
description: One of the oldest and most commonly used scores to assess function and pain with patients undergoing hip replacement surgery.
intervention type: Device
intervention name: Total hip replacement (2 different designs)
description: Patients will randomly receive either CFP or Corail stem
other name: CFP stem or Corail stem
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Johan Kärrholm, MD, PhD, Professor
role: Principal Investigator
affiliation: Sahlgrenska University Hospital, Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Johan Karrholm
investigator title: MD, Professor in Orthopaedics
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
sharing ipd: Undecided