Continuous Glucose Monitoring in Total Knee Arthroplasty With Preoperative High Dose Dexamethasone

May 25, 2021 updated by: The University of Hong Kong

Continuous Glucose Monitoring in Total Knee Arthroplasty With Preoperative High Dose Dexamethasone: A Randomized Controlled Study

Perioperative joint infection (PJI) is a rare but serious postoperative complication from total knee arthroplasty (TKA) and it is known to cause significant morbidities to the patients suffering from it. Literatures have found evidence that there is correlation between patients' perioperative blood glucose level and their risks of developing PJI postoperatively. By monitoring patients' perioperative blood glucose level, clinicians may be able to better identify patients who are at risks of developing PJI.

Continuous blood glucose level monitoring, where patients carry a blood glucose monitoring device, has been a novel intervention in various medical specialties for recording and monitoring patients' blood glucose levels. However, currently there has only limited studies using this intervention for perioperative blood glucose monitoring in patients who are receiving total knee arthroplasty.

Intravenous dexamethasone is a widely used treatment for patients undergoing total knee arthroplasty as it has been shown in previous studies that it can provide good analgesic effect and also reduce patients' nauesea symptoms preoperatively. However, hyperglycaemia is also a known side effects from dexamethasone. There still has not been ample amount of investigation on how significant this potential effect is and at what period of time perioperatively that this side effect occurs.

This study is designed to investigate how intravenous dexamethasone can potentially affect the perioperative blood glucose levels in patients receiving total knee arthroplasty. And by using a continuous glucose monitoring machine we are also aiming to find out the variability of the perioperative blood glucose profiles of these patients in order to design a better glucose monitoring schedule.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Perioperative joint infection (PJI) is a rare but serious postoperative complication from total knee arthroplasty (TKA) and it is known to cause significant morbidities to the patients suffering from it. Literatures have found evidence that there is correlation between patients' perioperative blood glucose level and their risks of developing PJI postoperatively. By monitoring patients' perioperative blood glucose level, clinicians may be able to better identify patients who are at risks of developing PJI.

Continuous blood glucose level monitoring, where patients carry a blood glucose monitoring device, has been a novel intervention in various medical specialties for recording and monitoring patients' blood glucose levels. However, currently there has only limited studies using this intervention for perioperative blood glucose monitoring in patients who are receiving total knee arthroplasty.

Intravenous dexamethasone is a widely used treatment for patients undergoing total knee arthroplasty as it has been shown in previous studies that it can provide good analgesic effect and also reduce patients' nauesea symptoms preoperatively. However, hyperglycaemia is also a known side effects from dexamethasone. There still has not been ample amount of investigation on how significant this potential effect is and at what period of time perioperatively that this side effect occurs.

This study is designed to investigate how intravenous dexamethasone can potentially affect the perioperative blood glucose levels in patients receiving total knee arthroplasty. And by using a continuous glucose monitoring machine we are also aiming to find out the variability of the perioperative blood glucose profiles of these patients in order to design a better glucose monitoring schedule.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obtained informed consent
  • Adult patients (>18 years old)
  • Primary osteoarthritis of knees scheduled for unilateral TKA

Exclusion Criteria:

  • Unable to obtain consent
  • Refusal to continuous glucose monitoring
  • Contraindication to dexamethasone
  • Patients scheduled for one-staged bilateral Total Knee Arthroplasty (TKA)
  • History of peptic ulcer/GI bleeding
  • Hepatitis B carrier
  • Patients on long-term steroid
  • Patients requiring general anesthesia for the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Diabetic patients with steroid
Procedure: Intraarticular injection of dexamethasone
Intraarticular injection of dexamethasone
PLACEBO_COMPARATOR: Diabetic patients without steroid
Injection of normal saline
Procedure: Intraarticular injection of dexamethasone
Intraarticular injection of dexamethasone
ACTIVE_COMPARATOR: Pre-diabetic patients with steroid
Procedure: Intraarticular injection of dexamethasone
Intraarticular injection of dexamethasone
PLACEBO_COMPARATOR: Pre-diabetic patients without steroid
Injection of normal saline
Procedure: Intraarticular injection of dexamethasone
Intraarticular injection of dexamethasone
ACTIVE_COMPARATOR: Non-diabetic patients with steroid
Procedure: Intraarticular injection of dexamethasone
Intraarticular injection of dexamethasone
PLACEBO_COMPARATOR: Non-diabetic patients without steroid
Injection of normal saline
Procedure: Intraarticular injection of dexamethasone
Intraarticular injection of dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperglycaemia time
Time Frame: Within 1 week of admission
Amount of time where patients are at hyperglycaemic state
Within 1 week of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Lik Hang Brian Leung, MBBS, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (ACTUAL)

May 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Glucose Monitor TKR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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