<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/NCT03825029</url>
  </required_header>
  <id_info>
    <org_study_id>20190058</org_study_id>
    <nct_id>NCT03825029</nct_id>
  </id_info>
  <brief_title>Pillow Use During Total Hip Arthroplasty</brief_title>
  <official_title>Can the Difference Between the Operative and Radiographic Cup Inclination Angle Be Reduced by Applying a Pillow Between the Patient's Legs in Total Hip Arthroplasty Performed In The Lateral Decubitus Position?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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 purpose of this study is to find out whether placing a pillow between the legs during hip&#xD;
      surgery will result in a better aligned hip replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During hip replacement surgery the cup is placed on specific planned angles. Cup placement&#xD;
      has an effect on the patients' pain-free range of movement, dislocation rates and&#xD;
      satisfaction. However, the angles of the cup orientation (i.e. the tilt and rotation), which&#xD;
      are preoperatively planned and postoperatively measured on radiographs, have a high&#xD;
      variability even when an experienced surgeon is performing the surgery. One of the reasons&#xD;
      this occurs is because the operated leg can move the pelvis to a different position in the&#xD;
      time between set-up and actual implantation which may lead to the cup being placed in a&#xD;
      non-optimal position. This study aims to see if the difference between planned and achieved&#xD;
      cup angles and pelvic movement can be lessened by putting a pillow in between the legs to&#xD;
      keep it in a stable horizontal position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 22, 2019</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in radiographic cup inclination angle</measure>
    <time_frame>Intra-operatively and post-operatively (within one month after the surgery)</time_frame>
    <description>The difference between the operative and postoperative radiographic cup inclination angle</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Arthroplasty, Replacement, Hip</condition>
  <condition>Hip Replacement, Total</condition>
  <arm_group>
    <arm_group_label>Pillow Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There will be a pillow placed between the patients legs during their operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>They will receive a normal total hip arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pillow</intervention_name>
    <description>A pillow to lessen the angle differences between hips so that the acetabular component can be placed in an optimal position.</description>
    <arm_group_label>Pillow Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient awaiting primary total hip arthroplasty using a posterior approach in a&#xD;
             lateral decubitus position&#xD;
&#xD;
          -  Patients capable of reading, understanding, and willing to sign the informed consent&#xD;
             form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Total hip arthroplasty not using a posterior approach in a lateral decubitus position&#xD;
&#xD;
          -  Prior hip osteotomy or fracture osteosynthesis on the index hip&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Grammatopoulos, MBBS BSc FRCS DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Johanna Dobransky, MHK, BSc, CCRP</last_name>
    <phone>6137378899</phone>
    <phone_ext>78785</phone_ext>
    <email>jdobransky@ohri.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Meaghan Dufresne</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>73032</phone_ext>
    <email>meadufresne@ohri.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johanna Dobransky</last_name>
      <phone>6137378899</phone>
      <phone_ext>78785</phone_ext>
      <email>jdobransky@ohri.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Ozaki Y, Baba T, Homma Y, Ochi H, Watari T, Banno S, Matsumoto M, Kaneko K. Posterior versus direct anterior approach in total hip arthroplasty: difference in patient-reported outcomes measured with the Forgotten Joint Score-12. SICOT J. 2018;4:54. doi: 10.1051/sicotj/2018051. Epub 2016 Nov 27.</citation>
    <PMID>30480545</PMID>
  </reference>
  <reference>
    <citation>Kennedy JG, Rogers WB, Soffe KE, Sullivan RJ, Griffen DG, Sheehan LJ. Effect of acetabular component orientation on recurrent dislocation, pelvic osteolysis, polyethylene wear, and component migration. J Arthroplasty. 1998 Aug;13(5):530-4. doi: 10.1016/s0883-5403(98)90052-3.</citation>
    <PMID>9726318</PMID>
  </reference>
  <reference>
    <citation>D'Lima DD, Urquhart AG, Buehler KO, Walker RH, Colwell CW Jr. The effect of the orientation of the acetabular and femoral components on the range of motion of the hip at different head-neck ratios. J Bone Joint Surg Am. 2000 Mar;82(3):315-21. doi: 10.2106/00004623-200003000-00003.</citation>
    <PMID>10724224</PMID>
  </reference>
  <reference>
    <citation>Grammatopoulos G, Thomas GE, Pandit H, Beard DJ, Gill HS, Murray DW. The effect of orientation of the acetabular component on outcome following total hip arthroplasty with small diameter hard-on-soft bearings. Bone Joint J. 2015 Feb;97-B(2):164-72. doi: 10.1302/0301-620X.97B2.34294.</citation>
    <PMID>25628277</PMID>
  </reference>
  <reference>
    <citation>Widmer KH. [Impingement Free Motion in Total Hip Arthroplasty - How Can We Implement It?]. Z Orthop Unfall. 2016 Aug;154(4):392-7. doi: 10.1055/s-0042-108065. Epub 2016 Jun 23. German.</citation>
    <PMID>27336842</PMID>
  </reference>
  <reference>
    <citation>Fujishiro T, Hiranaka T, Hashimoto S, Hayashi S, Kurosaka M, Kanno T, Masuda T. The effect of acetabular and femoral component version on dislocation in primary total hip arthroplasty. Int Orthop. 2016 Apr;40(4):697-702. doi: 10.1007/s00264-015-2924-2. Epub 2015 Jul 23.</citation>
    <PMID>26202021</PMID>
  </reference>
  <reference>
    <citation>Grammatopoulos G, Pandit HG, da Assuncao R, Taylor A, McLardy-Smith P, De Smet KA, Murray DW, Gill HS. Pelvic position and movement during hip replacement. Bone Joint J. 2014 Jul;96-B(7):876-83. doi: 10.1302/0301-620X.96B7.32107.</citation>
    <PMID>24986939</PMID>
  </reference>
  <reference>
    <citation>Meermans G, Goetheer-Smits I, Lim RF, Van Doorn WJ, Kats J. The difference between the radiographic and the operative angle of inclination of the acetabular component in total hip arthroplasty: use of a digital protractor and the circumference of the hip to improve orientation. Bone Joint J. 2015 May;97-B(5):603-10. doi: 10.1302/0301-620X.97B5.34781.</citation>
    <PMID>25922452</PMID>
  </reference>
  <reference>
    <citation>Wright JG. Small Simple Trials: A Strategy for Orthopaedic Randomized Trials. J Bone Joint Surg Am. 2018 Jul 18;100(14):e95. doi: 10.2106/JBJS.17.01107. No abstract available.</citation>
    <PMID>30020133</PMID>
  </reference>
  <reference>
    <citation>Langton DJ, Sprowson AP, Mahadeva D, Bhatnagar S, Holland JP, Nargol AV. Cup anteversion in hip resurfacing: validation of EBRA and the presentation of a simple clinical grading system. J Arthroplasty. 2010 Jun;25(4):607-13. doi: 10.1016/j.arth.2009.08.020. Epub 2009 Dec 21.</citation>
    <PMID>20022454</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03825029
org study id: 20190058
nct id: NCT03825029
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find out whether placing a pillow between the legs during hip
      surgery will result in a better aligned hip replacement.
During hip replacement surgery the cup is placed on specific planned angles. Cup placement
      has an effect on the patients' pain-free range of movement, dislocation rates and
      satisfaction. However, the angles of the cup orientation (i.e. the tilt and rotation), which
      are preoperatively planned and postoperatively measured on radiographs, have a high
      variability even when an experienced surgeon is performing the surgery. One of the reasons
      this occurs is because the operated leg can move the pelvis to a different position in the
      time between set-up and actual implantation which may lead to the cup being placed in a
      non-optimal position. This study aims to see if the difference between planned and achieved
      cup angles and pelvic movement can be lessened by putting a pillow in between the legs to
      keep it in a stable horizontal position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in radiographic cup inclination angle
time frame: Intra-operatively and post-operatively (within one month after the surgery)
description: The difference between the operative and postoperative radiographic cup inclination angle
arm group label: Pillow Group
arm group type: Experimental
description: There will be a pillow placed between the patients legs during their operation.
arm group label: Control Group
arm group type: No Intervention
description: They will receive a normal total hip arthroplasty.
intervention type: Procedure
intervention name: Pillow
description: A pillow to lessen the angle differences between hips so that the acetabular component can be placed in an optimal position.
arm group label: Pillow Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Grammatopoulos, MBBS BSc FRCS DPhil
role: Principal Investigator
affiliation: The Ottawa Hospital Research Institute
last name: Johanna Dobransky, MHK, BSc, CCRP
phone: 6137378899
phone ext: 78785
email: jdobransky@ohri.ca
last name: Meaghan Dufresne
phone: 613-737-8899
phone ext: 73032
email: meadufresne@ohri.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Ozaki Y, Baba T, Homma Y, Ochi H, Watari T, Banno S, Matsumoto M, Kaneko K. Posterior versus direct anterior approach in total hip arthroplasty: difference in patient-reported outcomes measured with the Forgotten Joint Score-12. SICOT J. 2018;4:54. doi: 10.1051/sicotj/2018051. Epub 2016 Nov 27.
PMID: 30480545
citation: Kennedy JG, Rogers WB, Soffe KE, Sullivan RJ, Griffen DG, Sheehan LJ. Effect of acetabular component orientation on recurrent dislocation, pelvic osteolysis, polyethylene wear, and component migration. J Arthroplasty. 1998 Aug;13(5):530-4. doi: 10.1016/s0883-5403(98)90052-3.
PMID: 9726318
citation: D'Lima DD, Urquhart AG, Buehler KO, Walker RH, Colwell CW Jr. The effect of the orientation of the acetabular and femoral components on the range of motion of the hip at different head-neck ratios. J Bone Joint Surg Am. 2000 Mar;82(3):315-21. doi: 10.2106/00004623-200003000-00003.
PMID: 10724224
citation: Grammatopoulos G, Thomas GE, Pandit H, Beard DJ, Gill HS, Murray DW. The effect of orientation of the acetabular component on outcome following total hip arthroplasty with small diameter hard-on-soft bearings. Bone Joint J. 2015 Feb;97-B(2):164-72. doi: 10.1302/0301-620X.97B2.34294.
PMID: 25628277
citation: Widmer KH. [Impingement Free Motion in Total Hip Arthroplasty - How Can We Implement It?]. Z Orthop Unfall. 2016 Aug;154(4):392-7. doi: 10.1055/s-0042-108065. Epub 2016 Jun 23. German.
PMID: 27336842
citation: Fujishiro T, Hiranaka T, Hashimoto S, Hayashi S, Kurosaka M, Kanno T, Masuda T. The effect of acetabular and femoral component version on dislocation in primary total hip arthroplasty. Int Orthop. 2016 Apr;40(4):697-702. doi: 10.1007/s00264-015-2924-2. Epub 2015 Jul 23.
PMID: 26202021
citation: Grammatopoulos G, Pandit HG, da Assuncao R, Taylor A, McLardy-Smith P, De Smet KA, Murray DW, Gill HS. Pelvic position and movement during hip replacement. Bone Joint J. 2014 Jul;96-B(7):876-83. doi: 10.1302/0301-620X.96B7.32107.
PMID: 24986939
citation: Meermans G, Goetheer-Smits I, Lim RF, Van Doorn WJ, Kats J. The difference between the radiographic and the operative angle of inclination of the acetabular component in total hip arthroplasty: use of a digital protractor and the circumference of the hip to improve orientation. Bone Joint J. 2015 May;97-B(5):603-10. doi: 10.1302/0301-620X.97B5.34781.
PMID: 25922452
citation: Wright JG. Small Simple Trials: A Strategy for Orthopaedic Randomized Trials. J Bone Joint Surg Am. 2018 Jul 18;100(14):e95. doi: 10.2106/JBJS.17.01107. No abstract available.
PMID: 30020133
citation: Langton DJ, Sprowson AP, Mahadeva D, Bhatnagar S, Holland JP, Nargol AV. Cup anteversion in hip resurfacing: validation of EBRA and the presentation of a simple clinical grading system. J Arthroplasty. 2010 Jun;25(4):607-13. doi: 10.1016/j.arth.2009.08.020. Epub 2009 Dec 21.
PMID: 20022454
responsible party type: Sponsor