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

Not Applicable

• Conditions: Knee Osteoarthritis; Diabetes
• Interventions: Procedure: Intraarticular injection of dexamethasone

• Registration Number: NCT04902638
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Study First Posted: 2021-05-26
• Last Update Posted: 2021-05-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic patients without steroid	Intraarticular injection of dexamethasone	Injection of normal saline
Pre-diabetic patients with steroid	Intraarticular injection of dexamethasone	-
Pre-diabetic patients without steroid	Intraarticular injection of dexamethasone	Injection of normal saline
Non-diabetic patients with steroid	Intraarticular injection of dexamethasone	-
Non-diabetic patients without steroid	Intraarticular injection of dexamethasone	Injection of normal saline
Diabetic patients with steroid	Intraarticular injection of dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Hyperglycaemia time	Within 1 week of admission	Amount of time where patients are at hyperglycaemic state

Trial Locations

Locations (1)

Duchess of Kent Children Hospital; 🇭🇰 Hong Kong, Hong Kong