<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/NCT04444570</url>
  </required_header>
  <id_info>
    <org_study_id>Glycemia / WarsawMU</org_study_id>
    <nct_id>NCT04444570</nct_id>
  </id_info>
  <brief_title>Continuous Glycemia Monitoring in Perioperative Period in Patients Undergoing Total Knee or Hip Arthroplasty</brief_title>
  <official_title>Continuous Glycemia Monitoring in Perioperative Period in Patients Undergoing Total Knee or Hip Arthroplasty: a Protocol of Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</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>
      All across surgery specialties, wound or implant infections constitute rare, yet potentially&#xD;
      severe complications of surgical procedure. It is considered, that glucose metabolism&#xD;
      disorders, e.g. diabetes, are one of the main risk factors of such condition.&#xD;
&#xD;
      Aim of the study The aim of the study is a prospective evaluation of glucose blood level and&#xD;
      its variability during 2 weeks before hospitalization and 2 weeks of postoperative period in&#xD;
      patients, that will undergo elective orthopaedic surgeries, and its impact on number of&#xD;
      cardiovascular and orthopaedic complications.&#xD;
&#xD;
      Materials and methods To this study, patients qualified for elective total knee or hip&#xD;
      replacement in the single orthopedic center will be recruited. 100 patients will be included&#xD;
      in this study. Every patient will be evaluated on the risk of developing diabetes mellitus in&#xD;
      10 years time and on the risk of death in 10 years due to the cardiovascular events. 14 days&#xD;
      before procedure patients will have continuous glucose level measurement sensor implemented&#xD;
      in subcutaneous tissue. After 14 days, during standard visit for stitches removal, the sensor&#xD;
      will be removed and glycemia data will be collected. Next, patients will have their casual&#xD;
      glucose blood level checked and surgery outcome, cardiovascular events or surgery&#xD;
      complication risk evaluated in 3-, 6- and 12 month follow-up visits.&#xD;
&#xD;
      Expected benefits of the study Results of this study may allow to define impact of&#xD;
      orthopaedic treatment on glycemia and possible necessity to modify treatment of hyperglycemia&#xD;
      in perioperative period in patients with Diabetes Mellitus type 2 (DM2). Moreover it will&#xD;
      allow to specify change of glucose levels and possibly implicating a need to monitor&#xD;
      perioperative glycemia in patients without carbohydrate metabolism disorders. Additionally,&#xD;
      the study will help to evaluate corelation between perioperative glucose blood level and the&#xD;
      risk of cardiovascular events or surgical complications in 1-year after the procedure, which&#xD;
      may decrease the risk of such incidents in the future (e.g. by adequate control and effective&#xD;
      treatment of hyperglycemia), hence may result in reduction of mortality and lesser lowering&#xD;
      of the quality of life in patients with DM2 or high risk of it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In every surgical subspeciality surgical site or implants infections are not common but&#xD;
      potentially devastating for patients health. One of the most known risk factors of such state&#xD;
      is glucose metabolism disorders. Such pathologies, containing diabetes mellitus, are&#xD;
      considered one of the most epidemic health-related problems in XXI century.&#xD;
&#xD;
      Diabetes is a civilization disease, caused mainly by obesity, unhealthy eating habits and&#xD;
      lack of physical activity. It was concerning about 108 million people in 1980, while in next&#xD;
      40 years this number grew 4-times and is expecting to reach almost 600 million people in&#xD;
      2035.&#xD;
&#xD;
      Total joint arthroplasty is considered the most effective way of treating the end-stage&#xD;
      osteoarthritis of hip and knee joints. It is estimated that every year more that one million&#xD;
      total joint replacements are performed in Europe. It is believed that our community is&#xD;
      getting older and that is the reason why the number of total joint replacements will be&#xD;
      growing, as well as patients expectations towards it. Even though total knee and hip&#xD;
      replacement have wonderful outcome and are improving significantly patients life and its&#xD;
      quality, there are several potential side effect that might lower patients limb function.&#xD;
&#xD;
      There were several studies confirming increased risk of surgical site or implants infections&#xD;
      in patients undergoing total joint replacements such as knee or hip, who had perioperative&#xD;
      poor glycemic control or had treated diabetes mellitus. However, there is lack of literature&#xD;
      concerning analysis of continuous glycemia measurements before and after hospital stay. There&#xD;
      are some promises that glycemic disturbances during postoperative period might also increase&#xD;
      risk of cardiovascular events in this time and more frequent periods of hypoglycemia, which&#xD;
      might result in higher risk of unconsciousness and falls. What is more higher cardiovascular&#xD;
      risk is corelated with higher risk of disability and death.&#xD;
&#xD;
      Results of this research will allow to investigate influence of orthopedic surgery on&#xD;
      glycemia and possible modifications of hyperglycemia treatment in perioperative period in&#xD;
      patients with diabetes or glucose intolerance. What is more it will allow to investigate&#xD;
      changes of glycemia in patients with normal glycemia metabolism, potentially protecting them&#xD;
      from hypoglycemia during hospital stay and increasing their awareness of potentially&#xD;
      suffering diabetes mellitus in the future. Additionally, this study will allow to corelate&#xD;
      perioperative glycemia levels with risk of cardiovascular events in one year follow-up, and&#xD;
      its influence on surgical site and implants complications. Thanks to these findings surgeons&#xD;
      will be able to lower the risk of such complications in the future, hence lowering mortality&#xD;
      and quality of life, especially in patients with diabetes mellitus and from the group with&#xD;
      high risk of developing this disorder.&#xD;
&#xD;
      Nowadays, with technological development concerning our every day life, also devices used in&#xD;
      medicine are getting more and more sophisticated and are making patients lifes easier. One of&#xD;
      the most prominent examples of such device are the &quot;discs&quot; implanted into the subcutaneous&#xD;
      tissue which might measure patients glycemia level. Thanks to it patients no longer need to&#xD;
      measure it with traditional glucometers, which action relayed on blood samples collected from&#xD;
      the tip of the finger. It was associated with every day unpleasant needling. Nowadays modern&#xD;
      solution allow patients to get the result from their devices on their smartphones by only&#xD;
      sliding it above the place of the implanted device.&#xD;
&#xD;
      Taking into considerations, such a wide spread of diabetes mellitus in our population it is&#xD;
      obvious, that among patients qualified for total hip or knee arthroplasty many of them will&#xD;
      have this disease. Adding to it common risk factors of diabetes and osteoarthritis, such as&#xD;
      obesity, it seems that number of patients with such diseases is much bigger than it seems.&#xD;
      According to the literature mentioned above it is obvious that microangiopathic changes, as&#xD;
      well as hyperglycemia, have negative influence on wound healing, surgery itself and might&#xD;
      increase the risk of periprosthetic infections. It is worthy to look for ways to optimize&#xD;
      patients care in perioperative period.&#xD;
&#xD;
      Additional good side of this study is a fact, that it contains patients without recognized&#xD;
      diabetes mellitus to assess their glycemia fluctuations, without carbohydrate metabolism&#xD;
      disorders. Such knowledge might improve and allow to develop the algorithm of perioperative&#xD;
      care for the high number of patients, who in such demanding for their body period are exposed&#xD;
      to significant glycemia fluctuations.&#xD;
&#xD;
      What is more, it must be admitted that this study has unique model (described below), in&#xD;
      which glycemia monitoring will contain both pre- and postoperative period of every included&#xD;
      patient. Such way of analyzing patients allows to produce &quot;perfect control group&quot;, because&#xD;
      every measurements after the surgery has its counterpart before the surgery.&#xD;
&#xD;
      The aim of this project is to prospectively evaluate the level of glycemia and its&#xD;
      variability in patients undergoing elective orthopedic surgeries during one month (two weeks&#xD;
      before the surgery and two weeks postoperatively) and its influence on the number of&#xD;
      cardiovascular and orthopedic complications. What is more the investigators want to evaluate&#xD;
      its influence on objective functional outcome of the surgery in one year follow-up. It seems&#xD;
      that long bone surgery as a stress factor might increase the risk of developing diabetes or&#xD;
      glucose intolerance, what might increase the risk of cardiovascular diseases and number of&#xD;
      complications.&#xD;
&#xD;
      To this prospective observational study, patients qualified for elective total knee or hip&#xD;
      replacement in the Department of Orthopedics and Rehabilitation in Miedzyleski Specialist&#xD;
      Hospital in Warsaw will be recruited. 100 patients will be included.&#xD;
&#xD;
      There were several studies confirming increased risk of surgical site or implants infections&#xD;
      in patients undergoing total joint replacements such as knee or hip, who had perioperative&#xD;
      poor glycemic control or had treated diabetes mellitus. However, there is lack of literature&#xD;
      concerning analysis of continuous glycemia measurements before and after hospital stay. There&#xD;
      are some premises that glycemic disturbances during postoperative period might also increase&#xD;
      risk of cardiovascular events in this time and more frequent periods of hypoglycemia, which&#xD;
      might result in higher risk of unconsciousness and falls. What is more higher cardiovascular&#xD;
      risk is corelated with higher risk of disability and death.&#xD;
&#xD;
      Results of this research will allow to investigate influence of orthopedic surgery on&#xD;
      glycemia and possible modifications of hyperglycemia treatment in perioperative period in&#xD;
      patients with diabetes or glucose intolerance. What is more it will allow to investigate&#xD;
      changes of glycemia in patients with normal glycemia metabolism, potentially protecting them&#xD;
      from hypoglycemia during hospital stay and increasing their awareness of potentially&#xD;
      suffering diabetes mellitus in the future. Additionally, this study will allow to corelate&#xD;
      perioperative glycemia levels with risk of cardiovascular events in one year follow-up, and&#xD;
      its influence on surgical site and implants complications. Thanks to these findings surgeons&#xD;
      will be able to lower the risk of such complications in the future, hence lowering mortality&#xD;
      and quality of life, especially in patients with diabetes mellitus and from the group with&#xD;
      high risk of developing this disorder.&#xD;
&#xD;
      Nowadays, with technological development concerning our every day life, also devices used in&#xD;
      medicine are getting more and more sophisticated and are making patients lifes easier. One of&#xD;
      the most prominent examples of such device are the &quot;discs&quot; implanted into the subcutaneous&#xD;
      tissue which might measure patients glycemia level. Thanks to it patients no longer need to&#xD;
      measure it with traditional glucometers, which action relayed on blood samples collected from&#xD;
      the tip of the finger. It was associated with every day unpleasant needling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of glycemia levels during perioperative period</measure>
    <time_frame>4 weeks (14 days preoperatively and 14 postoperatively)</time_frame>
    <description>Continuous glycemia level monitoring with use of subcutaneously implanted device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate and type cardiovascular events during follow-up</measure>
    <time_frame>12-months postoperatively</time_frame>
    <description>Any cardiovascular events during follow-up (heart stroke, brain stroke, coronal arteries disease, transient ischaemic attack (TIA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate and type of complications</measure>
    <time_frame>12-months postoperatively</time_frame>
    <description>Any surgical site and/or implants complications during follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective functional outcome in Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>14-days, 3-, 6-, and 12- months postoperatively</time_frame>
    <description>KOOS is a questionnaire designed to assess patient-relevant outcomes following knee injury. The KOOS assesses outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. All items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems). Scores between 0 and 100 represent the percentage of total possible score achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular events and/or surgical site or implants complications</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>Correlation of FINDRISC scale results with cardiovascular events and/or surgical site or implants complications</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Osteoarthritis, Hip</condition>
  <condition>Hyperglycemia</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>14 days before the date of the surgery every participant will have implemented the device for continuous glycemia measurement (Dexcom)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Right after the surgery every participant will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue</intervention_name>
    <description>14 days before the date of the surgery and after the surgery patient will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Power analysis was performed to assess how many patients should be included in the study.&#xD;
        Determining effect size was hindered by lack of literature comparing mean values and&#xD;
        standard deviations (SD) between groups with and without complications. The effect size can&#xD;
        be deemed &quot;large&quot;, described numerically as 0.8 by Cohen. However, we decide to be more&#xD;
        conservative and used effect size of 0.6, located between &quot;medium&quot; and &quot;large&quot; in Cohen's&#xD;
        scale. Standard p value of 0.05, beta value of 0.8 and allocation ratio of 1/1 were used,&#xD;
        resulting in total needed sample size of 90 patients. Taking into consideration that 10 %&#xD;
        of patients might drop off the follow-up predicted number of participants is 100.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients hospitalized in the Department of Orthopedics and Rehabilitation of Medical&#xD;
             University of Warsaw&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
          -  Qualified for total knee or hip replacement due to the primary osteoarthritis&#xD;
&#xD;
          -  Age above 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No acceptance to participate in the study&#xD;
&#xD;
          -  Qualified for non-surgical treatment&#xD;
&#xD;
          -  Patients with other diseases but diabetes mellitus, compensated thyroid disorders and&#xD;
             hypertension&#xD;
&#xD;
          -  Patients with poorly-controled diabetes mellitus and/or poorly-controlled hypertension&#xD;
&#xD;
          -  Patients with diabetes type 1&#xD;
&#xD;
          -  Patients from the rest-home&#xD;
&#xD;
          -  Patients who had previous lower limb surgeries&#xD;
&#xD;
          -  Patients who in opinion of research team might be poorly compliant&#xD;
&#xD;
          -  Patients during pregnancy&#xD;
&#xD;
          -  Patients who are not fluent in polish language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Artur Stolarczyk, qMD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bartosz M. Maciąg, MD</last_name>
    <phone>+48 881568144</phone>
    <email>bartosz.maciag94@gmail.com</email>
  </overall_contact>
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    <citation>OECD (2017), &quot;Hip and knee replacement&quot;, in Health at a Glance 2017: OECD Indicators, OECD Publishing, Paris.</citation>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Artur Stolarczyk</investigator_full_name>
    <investigator_title>Head of the Department of Orthopedics and Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>hip</keyword>
  <keyword>knee</keyword>
  <keyword>diabetes</keyword>
  <keyword>glycemia</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>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04444570
org study id: Glycemia / WarsawMU
nct id: NCT04444570
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
All across surgery specialties, wound or implant infections constitute rare, yet potentially
      severe complications of surgical procedure. It is considered, that glucose metabolism
      disorders, e.g. diabetes, are one of the main risk factors of such condition.

      Aim of the study The aim of the study is a prospective evaluation of glucose blood level and
      its variability during 2 weeks before hospitalization and 2 weeks of postoperative period in
      patients, that will undergo elective orthopaedic surgeries, and its impact on number of
      cardiovascular and orthopaedic complications.

      Materials and methods To this study, patients qualified for elective total knee or hip
      replacement in the single orthopedic center will be recruited. 100 patients will be included
      in this study. Every patient will be evaluated on the risk of developing diabetes mellitus in
      10 years time and on the risk of death in 10 years due to the cardiovascular events. 14 days
      before procedure patients will have continuous glucose level measurement sensor implemented
      in subcutaneous tissue. After 14 days, during standard visit for stitches removal, the sensor
      will be removed and glycemia data will be collected. Next, patients will have their casual
      glucose blood level checked and surgery outcome, cardiovascular events or surgery
      complication risk evaluated in 3-, 6- and 12 month follow-up visits.

      Expected benefits of the study Results of this study may allow to define impact of
      orthopaedic treatment on glycemia and possible necessity to modify treatment of hyperglycemia
      in perioperative period in patients with Diabetes Mellitus type 2 (DM2). Moreover it will
      allow to specify change of glucose levels and possibly implicating a need to monitor
      perioperative glycemia in patients without carbohydrate metabolism disorders. Additionally,
      the study will help to evaluate corelation between perioperative glucose blood level and the
      risk of cardiovascular events or surgical complications in 1-year after the procedure, which
      may decrease the risk of such incidents in the future (e.g. by adequate control and effective
      treatment of hyperglycemia), hence may result in reduction of mortality and lesser lowering
      of the quality of life in patients with DM2 or high risk of it.
In every surgical subspeciality surgical site or implants infections are not common but
      potentially devastating for patients health. One of the most known risk factors of such state
      is glucose metabolism disorders. Such pathologies, containing diabetes mellitus, are
      considered one of the most epidemic health-related problems in XXI century.

      Diabetes is a civilization disease, caused mainly by obesity, unhealthy eating habits and
      lack of physical activity. It was concerning about 108 million people in 1980, while in next
      40 years this number grew 4-times and is expecting to reach almost 600 million people in
      2035.

      Total joint arthroplasty is considered the most effective way of treating the end-stage
      osteoarthritis of hip and knee joints. It is estimated that every year more that one million
      total joint replacements are performed in Europe. It is believed that our community is
      getting older and that is the reason why the number of total joint replacements will be
      growing, as well as patients expectations towards it. Even though total knee and hip
      replacement have wonderful outcome and are improving significantly patients life and its
      quality, there are several potential side effect that might lower patients limb function.

      There were several studies confirming increased risk of surgical site or implants infections
      in patients undergoing total joint replacements such as knee or hip, who had perioperative
      poor glycemic control or had treated diabetes mellitus. However, there is lack of literature
      concerning analysis of continuous glycemia measurements before and after hospital stay. There
      are some promises that glycemic disturbances during postoperative period might also increase
      risk of cardiovascular events in this time and more frequent periods of hypoglycemia, which
      might result in higher risk of unconsciousness and falls. What is more higher cardiovascular
      risk is corelated with higher risk of disability and death.

      Results of this research will allow to investigate influence of orthopedic surgery on
      glycemia and possible modifications of hyperglycemia treatment in perioperative period in
      patients with diabetes or glucose intolerance. What is more it will allow to investigate
      changes of glycemia in patients with normal glycemia metabolism, potentially protecting them
      from hypoglycemia during hospital stay and increasing their awareness of potentially
      suffering diabetes mellitus in the future. Additionally, this study will allow to corelate
      perioperative glycemia levels with risk of cardiovascular events in one year follow-up, and
      its influence on surgical site and implants complications. Thanks to these findings surgeons
      will be able to lower the risk of such complications in the future, hence lowering mortality
      and quality of life, especially in patients with diabetes mellitus and from the group with
      high risk of developing this disorder.

      Nowadays, with technological development concerning our every day life, also devices used in
      medicine are getting more and more sophisticated and are making patients lifes easier. One of
      the most prominent examples of such device are the "discs" implanted into the subcutaneous
      tissue which might measure patients glycemia level. Thanks to it patients no longer need to
      measure it with traditional glucometers, which action relayed on blood samples collected from
      the tip of the finger. It was associated with every day unpleasant needling. Nowadays modern
      solution allow patients to get the result from their devices on their smartphones by only
      sliding it above the place of the implanted device.

      Taking into considerations, such a wide spread of diabetes mellitus in our population it is
      obvious, that among patients qualified for total hip or knee arthroplasty many of them will
      have this disease. Adding to it common risk factors of diabetes and osteoarthritis, such as
      obesity, it seems that number of patients with such diseases is much bigger than it seems.
      According to the literature mentioned above it is obvious that microangiopathic changes, as
      well as hyperglycemia, have negative influence on wound healing, surgery itself and might
      increase the risk of periprosthetic infections. It is worthy to look for ways to optimize
      patients care in perioperative period.

      Additional good side of this study is a fact, that it contains patients without recognized
      diabetes mellitus to assess their glycemia fluctuations, without carbohydrate metabolism
      disorders. Such knowledge might improve and allow to develop the algorithm of perioperative
      care for the high number of patients, who in such demanding for their body period are exposed
      to significant glycemia fluctuations.

      What is more, it must be admitted that this study has unique model (described below), in
      which glycemia monitoring will contain both pre- and postoperative period of every included
      patient. Such way of analyzing patients allows to produce "perfect control group", because
      every measurements after the surgery has its counterpart before the surgery.

      The aim of this project is to prospectively evaluate the level of glycemia and its
      variability in patients undergoing elective orthopedic surgeries during one month (two weeks
      before the surgery and two weeks postoperatively) and its influence on the number of
      cardiovascular and orthopedic complications. What is more the investigators want to evaluate
      its influence on objective functional outcome of the surgery in one year follow-up. It seems
      that long bone surgery as a stress factor might increase the risk of developing diabetes or
      glucose intolerance, what might increase the risk of cardiovascular diseases and number of
      complications.

      To this prospective observational study, patients qualified for elective total knee or hip
      replacement in the Department of Orthopedics and Rehabilitation in Miedzyleski Specialist
      Hospital in Warsaw will be recruited. 100 patients will be included.

      There were several studies confirming increased risk of surgical site or implants infections
      in patients undergoing total joint replacements such as knee or hip, who had perioperative
      poor glycemic control or had treated diabetes mellitus. However, there is lack of literature
      concerning analysis of continuous glycemia measurements before and after hospital stay. There
      are some premises that glycemic disturbances during postoperative period might also increase
      risk of cardiovascular events in this time and more frequent periods of hypoglycemia, which
      might result in higher risk of unconsciousness and falls. What is more higher cardiovascular
      risk is corelated with higher risk of disability and death.

      Results of this research will allow to investigate influence of orthopedic surgery on
      glycemia and possible modifications of hyperglycemia treatment in perioperative period in
      patients with diabetes or glucose intolerance. What is more it will allow to investigate
      changes of glycemia in patients with normal glycemia metabolism, potentially protecting them
      from hypoglycemia during hospital stay and increasing their awareness of potentially
      suffering diabetes mellitus in the future. Additionally, this study will allow to corelate
      perioperative glycemia levels with risk of cardiovascular events in one year follow-up, and
      its influence on surgical site and implants complications. Thanks to these findings surgeons
      will be able to lower the risk of such complications in the future, hence lowering mortality
      and quality of life, especially in patients with diabetes mellitus and from the group with
      high risk of developing this disorder.

      Nowadays, with technological development concerning our every day life, also devices used in
      medicine are getting more and more sophisticated and are making patients lifes easier. One of
      the most prominent examples of such device are the "discs" implanted into the subcutaneous
      tissue which might measure patients glycemia level. Thanks to it patients no longer need to
      measure it with traditional glucometers, which action relayed on blood samples collected from
      the tip of the finger. It was associated with every day unpleasant needling.
observational model: Cohort
time perspective: Prospective
measure: Changes of glycemia levels during perioperative period
time frame: 4 weeks (14 days preoperatively and 14 postoperatively)
description: Continuous glycemia level monitoring with use of subcutaneously implanted device
measure: Rate and type cardiovascular events during follow-up
time frame: 12-months postoperatively
description: Any cardiovascular events during follow-up (heart stroke, brain stroke, coronal arteries disease, transient ischaemic attack (TIA)
measure: Rate and type of complications
time frame: 12-months postoperatively
description: Any surgical site and/or implants complications during follow-up
measure: Objective functional outcome in Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 14-days, 3-, 6-, and 12- months postoperatively
description: KOOS is a questionnaire designed to assess patient-relevant outcomes following knee injury. The KOOS assesses outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. All items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems). Scores between 0 and 100 represent the percentage of total possible score achieved.
measure: Cardiovascular events and/or surgical site or implants complications
time frame: 12 months postoperatively
description: Correlation of FINDRISC scale results with cardiovascular events and/or surgical site or implants complications
arm group label: Control group
description: 14 days before the date of the surgery every participant will have implemented the device for continuous glycemia measurement (Dexcom)
arm group label: Study group
description: Right after the surgery every participant will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected
intervention type: Device
intervention name: Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue
description: 14 days before the date of the surgery and after the surgery patient will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected
arm group label: Control group
arm group label: Study group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Artur Stolarczyk, qMD, PhD
role: Study Chair
affiliation: Medical University of Warsaw
last name: Bartosz M. Maciąg, MD
phone: +48 881568144
email: bartosz.maciag94@gmail.com
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citation: OECD (2017), "Hip and knee replacement", in Health at a Glance 2017: OECD Indicators, OECD Publishing, Paris.
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Artur Stolarczyk
investigator title: Head of the Department of Orthopedics and Rehabilitation
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis, Hip
mesh term: Diabetes Mellitus, Type 2
mesh term: Hyperglycemia
sharing ipd: No