<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/NCT02253966</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2014-089</org_study_id>
    <nct_id>NCT02253966</nct_id>
  </id_info>
  <brief_title>Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lundbeck Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for&#xD;
      osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It&#xD;
      has been suggested that preoperative degree of intraarticular inflammation is associated to&#xD;
      postoperative degree of pain and level of function. Furthermore it is known, that patients&#xD;
      with preoperative inflammation have hyperalgesia and severe movement related pain.&#xD;
&#xD;
      The aim of this study is to investigate the effect of a preoperative intraarticular injection&#xD;
      of Methylprednisoloneacetate in reducing acute postoperative pain after total knee&#xD;
      arthroplasty in patients with signs of severe pre-operative inflammation and pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>From day 1 to day 14</time_frame>
    <description>Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>From day 1 to day 14</time_frame>
    <description>Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitisation</measure>
    <time_frame>On day 0 and day 2</time_frame>
    <description>Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>On day 0 and day 2</time_frame>
    <description>Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>On day 0</time_frame>
    <description>Measurement of interleukin-6 level in knee joint fluid on the day of surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Knee Joint Osteoarthrosis</condition>
  <condition>Hyperalgesia</condition>
  <condition>Severe Movement Related Pain</condition>
  <arm_group>
    <arm_group_label>Methylprednisoloneacetate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of:&#xD;
1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium chloride</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of:&#xD;
5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisoloneacetate</intervention_name>
    <arm_group_label>Methylprednisoloneacetate</arm_group_label>
    <other_name>Depo-Medrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <arm_group_label>Methylprednisoloneacetate</arm_group_label>
    <arm_group_label>Sodium chloride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sodium chloride</intervention_name>
    <arm_group_label>Methylprednisoloneacetate</arm_group_label>
    <arm_group_label>Sodium chloride</arm_group_label>
    <other_name>saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 50 -80&#xD;
&#xD;
          -  Osteoarthrosis&#xD;
&#xD;
          -  Scheduled for primary unilateral TKA&#xD;
&#xD;
          -  Preoperative pain report with NRS &gt; 5 upon walking&#xD;
&#xD;
          -  Signs of sensitisation in knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment&#xD;
&#xD;
          -  Deficient written or spoken danish&#xD;
&#xD;
          -  Impairment from psychological or neurological disease&#xD;
&#xD;
          -  Local og systemic infection&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Treatment with corticosteroid within 30 days of inclusion&#xD;
&#xD;
          -  Insulin treated diabetes mellitus&#xD;
&#xD;
          -  Anticoagulant therapy&#xD;
&#xD;
          -  ASA (American Society of Anaesthesia) class &gt; 3&#xD;
&#xD;
          -  General anaesthesia&#xD;
&#xD;
          -  Alchohol use &gt; 21 units / week&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>June 3, 2016</last_update_submitted>
  <last_update_submitted_qc>June 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Iben Engelund Luna</investigator_full_name>
    <investigator_title>MD, Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Hyperalgesia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_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/NCT02253966
org study id: H-3-2014-089
nct id: NCT02253966
lead sponsor: 
collaborator: 
has dmc: Yes
Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for
      osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It
      has been suggested that preoperative degree of intraarticular inflammation is associated to
      postoperative degree of pain and level of function. Furthermore it is known, that patients
      with preoperative inflammation have hyperalgesia and severe movement related pain.

      The aim of this study is to investigate the effect of a preoperative intraarticular injection
      of Methylprednisoloneacetate in reducing acute postoperative pain after total knee
      arthroplasty in patients with signs of severe pre-operative inflammation and pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain
time frame: 24 hours postoperatively
description: Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery
measure: Pain
time frame: 48 hours postoperatively
description: Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following
measure: Pain
time frame: From day 1 to day 14
description: Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day
measure: Pain
time frame: From day 1 to day 14
description: Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day
measure: Sensitisation
time frame: On day 0 and day 2
description: Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.
measure: Inflammation
time frame: On day 0 and day 2
description: Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day.
measure: Inflammation
time frame: On day 0
description: Measurement of interleukin-6 level in knee joint fluid on the day of surgery.
arm group label: Methylprednisoloneacetate
arm group type: Active Comparator
description: Administration of:
1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.
arm group label: Sodium chloride
arm group type: Placebo Comparator
description: Administration of:
5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.
intervention type: Drug
intervention name: Methylprednisoloneacetate
arm group label: Methylprednisoloneacetate
other name: Depo-Medrol
intervention type: Drug
intervention name: Lidocaine
arm group label: Methylprednisoloneacetate
arm group label: Sodium chloride
intervention type: Other
intervention name: sodium chloride
arm group label: Methylprednisoloneacetate
arm group label: Sodium chloride
other name: saline
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Iben Engelund Luna
investigator title: MD, Research Fellow
mesh term: Osteoarthritis
mesh term: Hyperalgesia
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Lidocaine
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate