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

Primary Purpose

Diabetes, Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Intraarticular injection of dexamethasone
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duchess of Kent Children HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Diabetic patients with steroid

Diabetic patients without steroid

Pre-diabetic patients with steroid

Pre-diabetic patients without steroid

Non-diabetic patients with steroid

Non-diabetic patients without steroid

Arm Description

Injection of normal saline

Injection of normal saline

Injection of normal saline

Outcomes

Primary Outcome Measures

Hyperglycaemia time
Amount of time where patients are at hyperglycaemic state

Secondary Outcome Measures

Full Information

First Posted
May 20, 2021
Last Updated
May 25, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04902638
Brief Title
Continuous Glucose Monitoring in Total Knee Arthroplasty With Preoperative High Dose Dexamethasone
Official Title
Continuous Glucose Monitoring in Total Knee Arthroplasty With Preoperative High Dose Dexamethasone: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Knee Osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetic patients with steroid
Arm Type
Active Comparator
Arm Title
Diabetic patients without steroid
Arm Type
Placebo Comparator
Arm Description
Injection of normal saline
Arm Title
Pre-diabetic patients with steroid
Arm Type
Active Comparator
Arm Title
Pre-diabetic patients without steroid
Arm Type
Placebo Comparator
Arm Description
Injection of normal saline
Arm Title
Non-diabetic patients with steroid
Arm Type
Active Comparator
Arm Title
Non-diabetic patients without steroid
Arm Type
Placebo Comparator
Arm Description
Injection of normal saline
Intervention Type
Procedure
Intervention Name(s)
Intraarticular injection of dexamethasone
Intervention Description
Intraarticular injection of dexamethasone
Primary Outcome Measure Information:
Title
Hyperglycaemia time
Description
Amount of time where patients are at hyperglycaemic state
Time Frame
Within 1 week of admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lik Hang Brian Leung, MBBS
Phone
(+852) 62909986
Email
bleung.811@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Chan, MBBS
Email
loveholika@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lik Hang Brian Leung, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duchess of Kent Children Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lik Hang Brian Leung, MBBS
Phone
(+852) 62909986
Email
bleung.811@gmail.com
First Name & Middle Initial & Last Name & Degree
Vincent Chan, MBBS
Email
loveholika@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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