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Clinical Trials/NCT04444570
NCT04444570UnknownNot Applicable

Continuous Glycemia Monitoring in Perioperative Period in Patients Undergoing Total Knee or Hip Arthroplasty: a Protocol of Observational Study

Medical University of Warsaw0 sites100 target enrollmentStarted: December 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Primary Endpoint
Changes of glycemia levels during perioperative period

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients hospitalized in the Department of Orthopedics and Rehabilitation of Medical University of Warsaw
  • Willingness to participate in the study
  • Qualified for total knee or hip replacement due to the primary osteoarthritis
  • Age above 18 years

Exclusion Criteria

  • No acceptance to participate in the study
  • Qualified for non-surgical treatment
  • Patients with other diseases but diabetes mellitus, compensated thyroid disorders and hypertension
  • Patients with poorly-controled diabetes mellitus and/or poorly-controlled hypertension
  • Patients with diabetes type 1
  • Patients from the rest-home
  • Patients who had previous lower limb surgeries
  • Patients who in opinion of research team might be poorly compliant
  • Patients during pregnancy
  • Patients who are not fluent in polish language

Outcomes

Primary Outcomes

Changes of glycemia levels during perioperative period

Time Frame: 4 weeks (14 days preoperatively and 14 postoperatively)

Continuous glycemia level monitoring with use of subcutaneously implanted device

Rate and type of complications

Time Frame: 12-months postoperatively

Any surgical site and/or implants complications during follow-up

Rate and type cardiovascular events during follow-up

Time Frame: 12-months postoperatively

Any cardiovascular events during follow-up (heart stroke, brain stroke, coronal arteries disease, transient ischaemic attack (TIA)

Secondary Outcomes

  • Objective functional outcome in Knee Injury and Osteoarthritis Outcome Score (KOOS)(14-days, 3-, 6-, and 12- months postoperatively)
  • Cardiovascular events and/or surgical site or implants complications(12 months postoperatively)

Investigators

Sponsor
Medical University of Warsaw
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Artur Stolarczyk

Head of the Department of Orthopedics and Rehabilitation

Medical University of Warsaw

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