xml: <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/NCT06032507</url>
    </required_header>
    <id_info>
      <org_study_id>IIBSP-HPL-2021-90</org_study_id>
      <nct_id>NCT06032507</nct_id>
    </id_info>
    <brief_title>Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty</brief_title>
    <official_title>Effect of High-pressure Pulsatile Lavage Versus Manual Rinsing on Bone Cement Penetration in Total Knee Arthroplasty - A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Background&#xD;
  &#xD;
        Bone irrigation is essential in cemented total knee arthroplasty surgical technique in order&#xD;
        to improve cement penetration and interdigitation into cancellous bone, that is going to&#xD;
        determine the strength of the bone-cement interface.&#xD;
  &#xD;
        Purpose&#xD;
  &#xD;
        To report the effect of high-pressure pulsatile lavage versus manual rinsing on bone cement&#xD;
        penetration in total knee arthroplasty.&#xD;
  &#xD;
        Methods&#xD;
  &#xD;
        This is a single-centre, prospective, randomized, controlled clinical trial. The study&#xD;
        included 100 patients undergoing primary total knee arthroplasty. All patients meeting&#xD;
        inclusion criteria were randomly assigned to the pulsed lavage or non-pulsed lavage group.&#xD;
        The cumulative bone cement penetration was radiologically assessed in antero posterior and&#xD;
        lateral radiograph views in 10 zones according to the Knee Society Scoring System. A&#xD;
        statistical analysis was performed between both groups comparing bone cement penetration&#xD;
        cumulative scores.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Anticipated">September 10, 2024</completion_date>
    <primary_completion_date type="Actual">March 1, 2023</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>100 patients undergoing primary TKA</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cumulative bone cement penetration</measure>
      <time_frame>48 hours postoperative xrays</time_frame>
      <description>The cumulative bone cement penetration was radiologically assessed in AP and lateral radiograph views in 10 zones according to the Knee Society Scoring System (for each zone, &lt;4 = nonprogressive, 5-9 = risk of progression, &gt;10 = risk of failure) - minimum 0, maximum non established-.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>Knee</condition>
    <arm_group>
      <arm_group_label>Pulsed lavagegroup</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Bone cementation with previous high-pressure pulsatile lavage</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-pulsed lavage group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Bone cementation with previous manual rinsing lavage</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bone lavage previous to cementation</intervention_name>
      <description>Bone lavage previous to cementation in total knee arthroplasty</description>
      <arm_group_label>Non-pulsed lavage group</arm_group_label>
      <arm_group_label>Pulsed lavagegroup</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;60 years&#xD;
  &#xD;
            -  Age &lt;89 years&#xD;
  &#xD;
            -  Clinical symptoms of knee osteoarthritis&#xD;
  &#xD;
            -  Failed conservative treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Metal allergies&#xD;
  &#xD;
            -  Active or latent knee sepsis&#xD;
  &#xD;
            -  Extensor mechanism dysfunction&#xD;
  &#xD;
            -  Morbid obesity&#xD;
  &#xD;
            -  Several peripheral vascular disease&#xD;
  &#xD;
            -  Noncompliance due to major psychiatric or neurological disorders.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hospital de la Santa Creu i Sant Pau</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002 Nov;(404):7-13. doi: 10.1097/00003086-200211000-00003.</citation>
      <PMID>12439231</PMID>
    </reference>
    <reference>
      <citation>Peters CL, Craig MA, Mohr RA, Bachus KN. Tibial component fixation with cement: full- versus surface-cementation techniques. Clin Orthop Relat Res. 2003 Apr;(409):158-68. doi: 10.1097/01.blo.0000058638.94987.20.</citation>
      <PMID>12671498</PMID>
    </reference>
    <reference>
      <citation>Maistrelli GL, Antonelli L, Fornasier V, Mahomed N. Cement penetration with pulsed lavage versus syringe irrigation in total knee arthroplasty. Clin Orthop Relat Res. 1995 Mar;(312):261-5.</citation>
      <PMID>7634612</PMID>
    </reference>
    <reference>
      <citation>Clarius M, Seeger JB, Jaeger S, Mohr G, Bitsch RG. The importance of pulsed lavage on interface temperature and ligament tension force in cemented unicompartmental knee arthroplasty. Clin Biomech (Bristol, Avon). 2012 May;27(4):372-6. doi: 10.1016/j.clinbiomech.2011.10.006. Epub 2011 Nov 1.</citation>
      <PMID>22051198</PMID>
    </reference>
    <reference>
      <citation>Jaeger S, Seeger JB, Schuld C, Bitsch RG, Clarius M. Tibial cementing in UKA: a three-dimensional analysis of the bone cement implant interface and the effect of bone lavage. J Arthroplasty. 2013 Oct;28(9 Suppl):191-4. doi: 10.1016/j.arth.2013.05.014. Epub 2013 Jun 21.</citation>
      <PMID>23790498</PMID>
    </reference>
    <reference>
      <citation>Ritter MA, Herbst SA, Keating EM, Faris PM. Radiolucency at the bone-cement interface in total knee replacement. The effects of bone-surface preparation and cement technique. J Bone Joint Surg Am. 1994 Jan;76(1):60-5. doi: 10.2106/00004623-199401000-00008.</citation>
      <PMID>8288666</PMID>
    </reference>
    <reference>
      <citation>14. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system - PubMed. https://pubmed.ncbi.nlm.nih.gov/2805502/. Accessed March 17, 2021.</citation>
    </reference>
    <reference>
      <citation>Wing N, Van Zyl N, Wing M, Corrigan R, Loch A, Wall C. Reliability of three radiographic classification systems for knee osteoarthritis among observers of different experience levels. Skeletal Radiol. 2021 Feb;50(2):399-405. doi: 10.1007/s00256-020-03551-4. Epub 2020 Aug 11.</citation>
      <PMID>32780155</PMID>
    </reference>
    <reference>
      <citation>Schlegel UJ, Bishop NE, Puschel K, Morlock MM, Nagel K. Comparison of different cement application techniques for tibial component fixation in TKA. Int Orthop. 2015 Jan;39(1):47-54. doi: 10.1007/s00264-014-2468-x. Epub 2014 Aug 1.</citation>
      <PMID>25082179</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>February 23, 2022</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Total Knee Arthroplasty Cementation</keyword>
    <keyword>Bone cement penetration</keyword>
    <keyword>High Pressure Pulsatile Lavage</keyword>
    <keyword>Pulsatile lavage</keyword>
    <keyword>Total Knee Arthroplasty</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032507
  org study id: IIBSP-HPL-2021-90
  nct id: NCT06032507
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Background
  
        Bone irrigation is essential in cemented total knee arthroplasty surgical technique in order
        to improve cement penetration and interdigitation into cancellous bone, that is going to
        determine the strength of the bone-cement interface.
  
        Purpose
  
        To report the effect of high-pressure pulsatile lavage versus manual rinsing on bone cement
        penetration in total knee arthroplasty.
  
        Methods
  
        This is a single-centre, prospective, randomized, controlled clinical trial. The study
        included 100 patients undergoing primary total knee arthroplasty. All patients meeting
        inclusion criteria were randomly assigned to the pulsed lavage or non-pulsed lavage group.
        The cumulative bone cement penetration was radiologically assessed in antero posterior and
        lateral radiograph views in 10 zones according to the Knee Society Scoring System. A
        statistical analysis was performed between both groups comparing bone cement penetration
        cumulative scores.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 100 patients undergoing primary TKA
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Cumulative bone cement penetration
  time frame: 48 hours postoperative xrays
  description: The cumulative bone cement penetration was radiologically assessed in AP and lateral radiograph views in 10 zones according to the Knee Society Scoring System (for each zone, <4 = nonprogressive, 5-9 = risk of progression, >10 = risk of failure) - minimum 0, maximum non established-.
  arm group label: Pulsed lavagegroup
  arm group type: Experimental
  description: Bone cementation with previous high-pressure pulsatile lavage
  arm group label: Non-pulsed lavage group
  arm group type: Experimental
  description: Bone cementation with previous manual rinsing lavage
  intervention type: Procedure
  intervention name: Bone lavage previous to cementation
  description: Bone lavage previous to cementation in total knee arthroplasty
  arm group label: Non-pulsed lavage group
  arm group label: Pulsed lavagegroup
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 89 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Spain
  citation: Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002 Nov;(404):7-13. doi: 10.1097/00003086-200211000-00003.
  PMID: 12439231
  citation: Peters CL, Craig MA, Mohr RA, Bachus KN. Tibial component fixation with cement: full- versus surface-cementation techniques. Clin Orthop Relat Res. 2003 Apr;(409):158-68. doi: 10.1097/01.blo.0000058638.94987.20.
  PMID: 12671498
  citation: Maistrelli GL, Antonelli L, Fornasier V, Mahomed N. Cement penetration with pulsed lavage versus syringe irrigation in total knee arthroplasty. Clin Orthop Relat Res. 1995 Mar;(312):261-5.
  PMID: 7634612
  citation: Clarius M, Seeger JB, Jaeger S, Mohr G, Bitsch RG. The importance of pulsed lavage on interface temperature and ligament tension force in cemented unicompartmental knee arthroplasty. Clin Biomech (Bristol, Avon). 2012 May;27(4):372-6. doi: 10.1016/j.clinbiomech.2011.10.006. Epub 2011 Nov 1.
  PMID: 22051198
  citation: Jaeger S, Seeger JB, Schuld C, Bitsch RG, Clarius M. Tibial cementing in UKA: a three-dimensional analysis of the bone cement implant interface and the effect of bone lavage. J Arthroplasty. 2013 Oct;28(9 Suppl):191-4. doi: 10.1016/j.arth.2013.05.014. Epub 2013 Jun 21.
  PMID: 23790498
  citation: Ritter MA, Herbst SA, Keating EM, Faris PM. Radiolucency at the bone-cement interface in total knee replacement. The effects of bone-surface preparation and cement technique. J Bone Joint Surg Am. 1994 Jan;76(1):60-5. doi: 10.2106/00004623-199401000-00008.
  PMID: 8288666
  citation: 14. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system - PubMed. https://pubmed.ncbi.nlm.nih.gov/2805502/. Accessed March 17, 2021.
  citation: Wing N, Van Zyl N, Wing M, Corrigan R, Loch A, Wall C. Reliability of three radiographic classification systems for knee osteoarthritis among observers of different experience levels. Skeletal Radiol. 2021 Feb;50(2):399-405. doi: 10.1007/s00256-020-03551-4. Epub 2020 Aug 11.
  PMID: 32780155
  citation: Schlegel UJ, Bishop NE, Puschel K, Morlock MM, Nagel K. Comparison of different cement application techniques for tibial component fixation in TKA. Int Orthop. 2015 Jan;39(1):47-54. doi: 10.1007/s00264-014-2468-x. Epub 2014 Aug 1.
  PMID: 25082179
  responsible party type: Sponsor
  sharing ipd: Undecided