<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/NCT03758183</url>
  </required_header>
  <id_info>
    <org_study_id>TokatSH</org_study_id>
    <nct_id>NCT03758183</nct_id>
  </id_info>
  <brief_title>Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty</brief_title>
  <official_title>Cost Effectiveness of Two-stage Algorithm (Prolotherapy Injections Prior to Total Knee Arthroplasty) in the Management of Advanced Stage Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tokat State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tokat State Hospital</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>
      This study compared the cost effectiveness of two-stage algorithm (prolotherapy injections&#xD;
      (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)) and&#xD;
      one-stage algorithm (TKA) in the management of advanced stage knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the present study was to compare the cost effectiveness of two-stage algorithm&#xD;
      (prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee&#xD;
      arthroplasty (TKA)) and one-stage algorithm (TKA) in the management of advanced stage knee&#xD;
      osteoarthritis.&#xD;
&#xD;
      A total of 197 patients who had chronic knee osteoarthritis were included in the present&#xD;
      study. The patients were divided into two groups as two-stage algorithm (PrT combined with RP&#xD;
      prior to TKA), (Group A, n=98) and one-stage (TKA),(Group B, n=99). Clinical effectiveness&#xD;
      was evaluated via Visual Analog Scale (VAS), The Western Ontario and McMaster Universities&#xD;
      Arthritis Index (WOMAC) at baseline and 3-, 6-, 12-, and 18-month follow-ups. Utility scores&#xD;
      of the groups were obtained by extracting and converting WOMAC scores to health utilities&#xD;
      index mark 3 scores. Cost-utility per quality-adjusted life years (QALY) and Incremental&#xD;
      cost-effectiveness ratios (ICERs) of each group were calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">October 24, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>18 months</time_frame>
    <description>Self reported pain intensity. Each item is scored 0-10 (0=no pain; 10= pain as bad as can be), yielding a total between 0 and 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Western Ontario and McMaster Universities Arthritis Index (WOMAC)</measure>
    <time_frame>18 months</time_frame>
    <description>Self-administered questionnaire consisting of 24 items divided into 3 subscales:&#xD;
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. Each item is scored 0-96 (0=minimum; 96= as bad as can be), yielding a total between 0 and 96.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">197</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>two-stage algorithm</arm_group_label>
    <description>Prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>one-stage algorithm</arm_group_label>
    <description>total knee arthroplasty (TKA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>total knee arthroplasty</intervention_name>
    <arm_group_label>one-stage algorithm</arm_group_label>
    <arm_group_label>two-stage algorithm</arm_group_label>
    <other_name>injection</other_name>
    <other_name>prolotherapy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Age of the patients varied between 50 and 90&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  III and IV levels of knee osteoarthritis according to Kellgren-Lawrence&#xD;
&#xD;
          -  Had at least six months of symptoms resistant to at least three months of conservative&#xD;
             methods (lifestyle modification, weight reduction, regular exercise, physiotherapy,&#xD;
             non-steroidal anti-inflammatory drugs, intraarticular injection methods) -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With rheumatic diseases, immune diseases or other systemic inflammatory diseases&#xD;
&#xD;
          -  With active infection, osteomyelitis or history of chronic infection around knee joint&#xD;
&#xD;
          -  Had undergone previous operation on knee&#xD;
&#xD;
          -  Had bleeding tendency (hereditary or acquired)&#xD;
&#xD;
          -  Pregnant patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serkan Akpancar, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Tokat State Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Serkan Akpancar</name>
      <address>
        <city>Tokat</city>
        <zip>60060</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tokat State Hospital</investigator_affiliation>
    <investigator_full_name>Serkan Akpancar</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Arthroplasty</keyword>
  <keyword>Prolotherapy</keyword>
  <keyword>Osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All primary and secondary data will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available with in 3 months of the study completed</ipd_time_frame>
    <ipd_access_criteria>Data will be reviewed by external independent review panel. Requesters will be required to sign a data access agreement.</ipd_access_criteria>
  </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/NCT03758183
org study id: TokatSH
nct id: NCT03758183
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compared the cost effectiveness of two-stage algorithm (prolotherapy injections
      (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)) and
      one-stage algorithm (TKA) in the management of advanced stage knee osteoarthritis.
The aim of the present study was to compare the cost effectiveness of two-stage algorithm
      (prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee
      arthroplasty (TKA)) and one-stage algorithm (TKA) in the management of advanced stage knee
      osteoarthritis.

      A total of 197 patients who had chronic knee osteoarthritis were included in the present
      study. The patients were divided into two groups as two-stage algorithm (PrT combined with RP
      prior to TKA), (Group A, n=98) and one-stage (TKA),(Group B, n=99). Clinical effectiveness
      was evaluated via Visual Analog Scale (VAS), The Western Ontario and McMaster Universities
      Arthritis Index (WOMAC) at baseline and 3-, 6-, 12-, and 18-month follow-ups. Utility scores
      of the groups were obtained by extracting and converting WOMAC scores to health utilities
      index mark 3 scores. Cost-utility per quality-adjusted life years (QALY) and Incremental
      cost-effectiveness ratios (ICERs) of each group were calculated.
observational model: Cohort
time perspective: Retrospective
measure: Visual Analog Scale (VAS)
time frame: 18 months
description: Self reported pain intensity. Each item is scored 0-10 (0=no pain; 10= pain as bad as can be), yielding a total between 0 and 10.
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: 18 months
description: Self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. Each item is scored 0-96 (0=minimum; 96= as bad as can be), yielding a total between 0 and 96.
arm group label: two-stage algorithm
description: Prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)
arm group label: one-stage algorithm
description: total knee arthroplasty (TKA)
intervention type: Procedure
intervention name: total knee arthroplasty
arm group label: one-stage algorithm
arm group label: two-stage algorithm
other name: injection
other name: prolotherapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
last name: Serkan Akpancar, Dr
role: Study Director
affiliation: Tokat State Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Tokat State Hospital
investigator full name: Serkan Akpancar
investigator title: Dr
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Yes
ipd description: All primary and secondary data will be made available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available with in 3 months of the study completed
ipd access criteria: Data will be reviewed by external independent review panel. Requesters will be required to sign a data access agreement.