<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/NCT04432012</url>
  </required_header>
  <id_info>
    <org_study_id>ORL-ORT-013</org_study_id>
    <nct_id>NCT04432012</nct_id>
  </id_info>
  <brief_title>A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation</brief_title>
  <official_title>Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplasty for Knee Osteoarthritis - A Randomized Controlled Trial Clinical Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christian Candrian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ente Ospedaliero Cantonale, Bellinzona</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      We are going to evaluate the difference between perioperative intravenous steroid&#xD;
      supplementation, perioperative periarticular steroid supplementation, and standard&#xD;
      anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who&#xD;
      are undergoing Total Knee Arthroplasty to understand which of the three treatments give more&#xD;
      benefits to the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 159 patients will be needed (53 patients per arm, 3 arms in total). Dexamethasone&#xD;
      (brand name: Mephameson) is the steroid drug that we perioperative administer in two&#xD;
      different ways: intra-venous (IV) dexamethasone (9mg) in arm-A, intra-articular (IA)&#xD;
      dexamethasone (9mg) in arm-B. No steroid supplementation will be provided in the control&#xD;
      group (arm-C).&#xD;
&#xD;
      The primary objective of the study is to compare the effect on post-operative pain of I.V.&#xD;
      and I.A. perioperative dexamethasone supplementation for total knee arthroplasty (TKA).&#xD;
&#xD;
      The secondary objectives of the studies will be the comparison between I.V. and I.A.&#xD;
      peri-operative dexamethasone supplementation in terms of post-operative pain and function,&#xD;
      opioids and analgesic drugs consumption, knee range of motion, systemic inflammatory&#xD;
      response, time to mobilisation, length of stay, and patient satisfaction.&#xD;
&#xD;
      Moreover, both I.V. and I.A. steroid supplementation protocols will be compared to routine&#xD;
      analgesia protocol (no steroid supplementation group) in order to document their advantages&#xD;
      over the absence of steroid supplementation.&#xD;
&#xD;
      The safety of I.V. and I.A. peri-operative dexamethasone will be evaluated and compared&#xD;
      recording all the steroid supplementation related complications. In particular, the risk of&#xD;
      hyperglycaemia-related complications and post-operative infections will be documented. The&#xD;
      safety of both I.V. and I.A. steroid supplementation protocols will be verified comparing&#xD;
      them to the no-treatment group in terms of incidence of complications.&#xD;
&#xD;
      Overall study duration will be 12 years: 2 years to enroll all the patients and 10 years to&#xD;
      complete the last follow-up. Primary data analysis is planned after the completion of the&#xD;
      1-year follow-up visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2032</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The present study will be double blinded: both participants and assessor will be blinded to the assigned treatment. Only the surgeons and the anaesthetists taking part to surgery will be aware of the group to which the patient was assigned but they will not take part to the follow-up visits.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Mean daily pain at rest during the first 3 days reported on a 0-10 numeric rating scale (NRS) by the patients.&#xD;
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>Pain reported on 0-10 numeric rating scale (NRS) during the first 6 weeks and documented with a mobile application (developed at our Institution) that will ask the patients to report pain twice a day (once in the morning, once in the evening). Comparison will be performed in terms of mean daily pain during the first 6 weeks and mean daily pain during every single week.&#xD;
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative knee pain during the first 10 years after surgery</measure>
    <time_frame>10 years</time_frame>
    <description>reported on 0-10 NRS at 3, 6, 12, 24, 60 and 120 months using a questionnaire. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative function during the first 6 weeks after surgery</measure>
    <time_frame>6 weeks</time_frame>
    <description>reported on 0-10 NRS 8see above) during the first 6 weeks, documented with a mobile application developed by our institution that will ask the patients to report pain twice a day (once in the morning, once in the evening). Comparison will be performed in terms of mean daily pain during the first 6 weeks and mean daily pain during every single week. Furthermore, pain trajectories will be created.&#xD;
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating the worst possible function and 10 reflecting the best possible function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative knee function during the first 10 years after surgery</measure>
    <time_frame>10 years</time_frame>
    <description>reported on 0-10 NRS at 3, 6, 12, 24, 60 and 120 months using a questionnaire. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating the worst possible function and 10 reflecting the best possible function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC)</measure>
    <time_frame>10 years</time_frame>
    <description>Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis.&#xD;
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee conditions on Knee society score (KSS)</measure>
    <time_frame>10 years</time_frame>
    <description>Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. The original KSS has a &quot;Knee Score&quot; section (7 items) and a &quot;Functional Score&quot; section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of pain on PainDETECT questionnaire</measure>
    <time_frame>10 years</time_frame>
    <description>Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. PainDETECT consists of seven questions that address the quality of pain symptoms; it is completed by the patient and no physical examination is required. A score ≤12 indicates that pain is unlikely to have a neuropathic component (&lt; 15%), while a score of ≥19 suggests that pain is likely to have a neuropathic component (&gt; 90%). An intermediate score (≥13, ≤18) indicates a possible neuropathic component .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: numeric rating scale (NRS)</measure>
    <time_frame>10 years</time_frame>
    <description>Patient satisfaction reported on 0-10 numeric rating scale (NRS) at 3, 6, 12, 24, 60 and 120 months using a questionnaire.&#xD;
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating that patient is not satisfied at all and 10 reflecting that patient is totally satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative nausea incidence</measure>
    <time_frame>During Hospitalization, approximately 3 days</time_frame>
    <description>incidence (on a 0-10 NRS) of nausea will be evaluated in the first post-operative days.&#xD;
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the maximum intensity of nausea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative nausea intensity</measure>
    <time_frame>During Hospitalization, approximately 3 days</time_frame>
    <description>intensity (on a 0-10 NRS) of nausea will be evaluated in the first post-operative days.&#xD;
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the maximum intensity of nausea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative opioids and analgesic drugs consumption</measure>
    <time_frame>During Hospitalization, approximately 3 days</time_frame>
    <description>Medication Quantification Scale (MQS) score will be used to evaluate analgesic drug consumption.&#xD;
Medication Quantification Scale (MQS) scor is calculated for each medication by taking a consensus-based detriment weight for a given pharmacologic class and multiplying it by a score for dosage. The calculated values for each medication are then summed for a total MQS score. The score can provide a useful point measure of medication usage for any pain medication regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative C-Reactive Protein (CRP)</measure>
    <time_frame>every days 3 days from surgery</time_frame>
    <description>Hematic C-Reactive Protein in mg/L will be evaluated as index of post-operative inflammatory response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative erythrocyte sedimentation rate (ESR)</measure>
    <time_frame>every days 3 days from surgery</time_frame>
    <description>Erythrocyte sedimentation rate (mm/h) will be evaluated as index of post-operative inflammatory response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from surgery to first mobilization</measure>
    <time_frame>During Hospitalization, approximately 1 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time needed for climbing stairs the first time</measure>
    <time_frame>approximately 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>approximately 1 week</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of patients with treatment-related adverse events</measure>
    <time_frame>10 years</time_frame>
    <description>The safety of I.V. and I.A. dexamethasone supplementation will be evaluated in terms of: rate of serious adverse events related to steroid supplementation, rate of prosthetic joint infections, rate of wound infections, rate of wound healing problems.&#xD;
Furthermore, glycaemia will be evaluated daily during the first three days after surgery.&#xD;
To delineate a complete safety profile of dexamethasone supplementation, all treatment related adverse events will be reported.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">159</enrollment>
  <condition>Total Knee Replacement</condition>
  <arm_group>
    <arm_group_label>arm-A Intra-venous dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9 mg of Intra-venous dexamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm-B intra-articular dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9 mg of intra-articular dexamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm-C routine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Sodium Phosphate 4 mg/ml intravenous</intervention_name>
    <description>Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)</description>
    <arm_group_label>arm-A Intra-venous dexamethasone</arm_group_label>
    <other_name>Mephameson</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Sodium Phosphate 4 mg/ml intra-articular</intervention_name>
    <description>Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)</description>
    <arm_group_label>arm-B intra-articular dexamethasone</arm_group_label>
    <other_name>Mephameson</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing unilateral primary TKA at the Ospedale Regionale di Lugano.&#xD;
&#xD;
          -  Patients with a BMI &gt;18.5 and &lt;35.&#xD;
&#xD;
          -  Patients able to provide informed consent and follow all the study procedures as&#xD;
             indicated by the protocol.&#xD;
&#xD;
          -  Informed Consent as documented by signature (Appendix Informed Consent Form).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to steroids.&#xD;
&#xD;
          -  Revision TKA.&#xD;
&#xD;
          -  Active steroid therapy.&#xD;
&#xD;
          -  Women who are pregnant or breast feeding.&#xD;
&#xD;
          -  Presence of other clinically significant concomitant disease states (ASA IV).&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse.&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant.&#xD;
&#xD;
          -  Participation in another study with investigational drug within the 30 days preceding&#xD;
             and during the present study.&#xD;
&#xD;
          -  Previous enrolment into the current study.&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Candrian, MD, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>EOC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Candrian, MD, Prof</last_name>
    <phone>+41 (0) 91 811 61 23</phone>
    <email>christian.candrian@eoc.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marco Delcogliano, MD</last_name>
    <phone>+41 (0)91 811 66 56</phone>
    <email>marco.delcogliano@eoc.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ospedale Regionale di Lugano Civico e Italiano</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Candrian, MD, Prof</last_name>
      <phone>+41 (0)91 811 7029</phone>
      <email>christian.candrian@eoc.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ente Ospedaliero Cantonale, Bellinzona</investigator_affiliation>
    <investigator_full_name>Christian Candrian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Knee</keyword>
  <keyword>surgery</keyword>
  <keyword>replacement</keyword>
  <keyword>arthroplasty</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Dexamethasone 21-phosphate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>not foreseen</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/NCT04432012
org study id: ORL-ORT-013
nct id: NCT04432012
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
We are going to evaluate the difference between perioperative intravenous steroid
      supplementation, perioperative periarticular steroid supplementation, and standard
      anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who
      are undergoing Total Knee Arthroplasty to understand which of the three treatments give more
      benefits to the patient.
A total of 159 patients will be needed (53 patients per arm, 3 arms in total). Dexamethasone
      (brand name: Mephameson) is the steroid drug that we perioperative administer in two
      different ways: intra-venous (IV) dexamethasone (9mg) in arm-A, intra-articular (IA)
      dexamethasone (9mg) in arm-B. No steroid supplementation will be provided in the control
      group (arm-C).

      The primary objective of the study is to compare the effect on post-operative pain of I.V.
      and I.A. perioperative dexamethasone supplementation for total knee arthroplasty (TKA).

      The secondary objectives of the studies will be the comparison between I.V. and I.A.
      peri-operative dexamethasone supplementation in terms of post-operative pain and function,
      opioids and analgesic drugs consumption, knee range of motion, systemic inflammatory
      response, time to mobilisation, length of stay, and patient satisfaction.

      Moreover, both I.V. and I.A. steroid supplementation protocols will be compared to routine
      analgesia protocol (no steroid supplementation group) in order to document their advantages
      over the absence of steroid supplementation.

      The safety of I.V. and I.A. peri-operative dexamethasone will be evaluated and compared
      recording all the steroid supplementation related complications. In particular, the risk of
      hyperglycaemia-related complications and post-operative infections will be documented. The
      safety of both I.V. and I.A. steroid supplementation protocols will be verified comparing
      them to the no-treatment group in terms of incidence of complications.

      Overall study duration will be 12 years: 2 years to enroll all the patients and 10 years to
      complete the last follow-up. Primary data analysis is planned after the completion of the
      1-year follow-up visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The present study will be double blinded: both participants and assessor will be blinded to the assigned treatment. Only the surgeons and the anaesthetists taking part to surgery will be aware of the group to which the patient was assigned but they will not take part to the follow-up visits.
measure: Mean daily pain at rest during the first 3 days on a 0-10 numeric rating scale
time frame: 3 days after surgery
description: Mean daily pain at rest during the first 3 days reported on a 0-10 numeric rating scale (NRS) by the patients.
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.
measure: Post-operative knee pain during the first 6 weeks after surgery on a 0-10 numeric rating scale
time frame: 6 weeks after surgery
description: Pain reported on 0-10 numeric rating scale (NRS) during the first 6 weeks and documented with a mobile application (developed at our Institution) that will ask the patients to report pain twice a day (once in the morning, once in the evening). Comparison will be performed in terms of mean daily pain during the first 6 weeks and mean daily pain during every single week.
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.
measure: Post-operative knee pain during the first 10 years after surgery
time frame: 10 years
description: reported on 0-10 NRS at 3, 6, 12, 24, 60 and 120 months using a questionnaire. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no pain and 10 reflecting the worst possible pain.
measure: Post-operative function during the first 6 weeks after surgery
time frame: 6 weeks
description: reported on 0-10 NRS 8see above) during the first 6 weeks, documented with a mobile application developed by our institution that will ask the patients to report pain twice a day (once in the morning, once in the evening). Comparison will be performed in terms of mean daily pain during the first 6 weeks and mean daily pain during every single week. Furthermore, pain trajectories will be created.
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating the worst possible function and 10 reflecting the best possible function.
measure: Post-operative knee function during the first 10 years after surgery
time frame: 10 years
description: reported on 0-10 NRS at 3, 6, 12, 24, 60 and 120 months using a questionnaire. The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating the worst possible function and 10 reflecting the best possible function.
measure: Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: 10 years
description: Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
measure: Knee conditions on Knee society score (KSS)
time frame: 10 years
description: Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
measure: Quality of pain on PainDETECT questionnaire
time frame: 10 years
description: Questionnaire at 2 and 6 weeks, and at 3, 6, 12, 24, 60 and 120 months. PainDETECT consists of seven questions that address the quality of pain symptoms; it is completed by the patient and no physical examination is required. A score ≤12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of ≥19 suggests that pain is likely to have a neuropathic component (> 90%). An intermediate score (≥13, ≤18) indicates a possible neuropathic component .
measure: Patient satisfaction: numeric rating scale (NRS)
time frame: 10 years
description: Patient satisfaction reported on 0-10 numeric rating scale (NRS) at 3, 6, 12, 24, 60 and 120 months using a questionnaire.
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating that patient is not satisfied at all and 10 reflecting that patient is totally satisfied.
measure: Post-operative nausea incidence
time frame: During Hospitalization, approximately 3 days
description: incidence (on a 0-10 NRS) of nausea will be evaluated in the first post-operative days.
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the maximum intensity of nausea.
measure: Post-operative nausea intensity
time frame: During Hospitalization, approximately 3 days
description: intensity (on a 0-10 NRS) of nausea will be evaluated in the first post-operative days.
The 0-10 NRS consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the maximum intensity of nausea.
measure: Post-operative opioids and analgesic drugs consumption
time frame: During Hospitalization, approximately 3 days
description: Medication Quantification Scale (MQS) score will be used to evaluate analgesic drug consumption.
Medication Quantification Scale (MQS) scor is calculated for each medication by taking a consensus-based detriment weight for a given pharmacologic class and multiplying it by a score for dosage. The calculated values for each medication are then summed for a total MQS score. The score can provide a useful point measure of medication usage for any pain medication regimen.
measure: Post-operative C-Reactive Protein (CRP)
time frame: every days 3 days from surgery
description: Hematic C-Reactive Protein in mg/L will be evaluated as index of post-operative inflammatory response.
measure: Post-operative erythrocyte sedimentation rate (ESR)
time frame: every days 3 days from surgery
description: Erythrocyte sedimentation rate (mm/h) will be evaluated as index of post-operative inflammatory response.
measure: Time from surgery to first mobilization
time frame: During Hospitalization, approximately 1 days
measure: Time needed for climbing stairs the first time
time frame: approximately 1 week
measure: Length of hospital stay
time frame: approximately 1 week
measure: Number of patients with treatment-related adverse events
time frame: 10 years
description: The safety of I.V. and I.A. dexamethasone supplementation will be evaluated in terms of: rate of serious adverse events related to steroid supplementation, rate of prosthetic joint infections, rate of wound infections, rate of wound healing problems.
Furthermore, glycaemia will be evaluated daily during the first three days after surgery.
To delineate a complete safety profile of dexamethasone supplementation, all treatment related adverse events will be reported.
arm group label: arm-A Intra-venous dexamethasone
arm group type: Experimental
description: 9 mg of Intra-venous dexamethasone
arm group label: arm-B intra-articular dexamethasone
arm group type: Experimental
description: 9 mg of intra-articular dexamethasone
arm group label: arm-C routine
arm group type: No Intervention
description: No steroid supplementation or other drugs will be added to the routinely performed anaesthesia protocol in the control group
intervention type: Drug
intervention name: Dexamethasone Sodium Phosphate 4 mg/ml intravenous
description: Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)
arm group label: arm-A Intra-venous dexamethasone
other name: Mephameson
intervention type: Drug
intervention name: Dexamethasone Sodium Phosphate 4 mg/ml intra-articular
description: Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
arm group label: arm-B intra-articular dexamethasone
other name: Mephameson
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Christian Candrian, MD, Prof.
role: Principal Investigator
affiliation: EOC
last name: Christian Candrian, MD, Prof
phone: +41 (0) 91 811 61 23
email: christian.candrian@eoc.ch
last name: Marco Delcogliano, MD
phone: +41 (0)91 811 66 56
email: marco.delcogliano@eoc.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Ente Ospedaliero Cantonale, Bellinzona
investigator full name: Christian Candrian
investigator title: Principal Investigator
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Dexamethasone 21-phosphate
mesh term: BB 1101
sharing ipd: No
ipd description: not foreseen