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

NCT ID: NCT04902638

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Diabetic patients with steroid

Group Type ACTIVE_COMPARATOR

Intraarticular injection of dexamethasone

Intervention Type PROCEDURE

Intraarticular injection of dexamethasone

Diabetic patients without steroid

Injection of normal saline

Group Type PLACEBO_COMPARATOR

Intraarticular injection of dexamethasone

Intervention Type PROCEDURE

Intraarticular injection of dexamethasone

Pre-diabetic patients with steroid

Group Type ACTIVE_COMPARATOR

Intraarticular injection of dexamethasone

Intervention Type PROCEDURE

Intraarticular injection of dexamethasone

Pre-diabetic patients without steroid

Injection of normal saline

Group Type PLACEBO_COMPARATOR

Intraarticular injection of dexamethasone

Intervention Type PROCEDURE

Intraarticular injection of dexamethasone

Non-diabetic patients with steroid

Group Type ACTIVE_COMPARATOR

Intraarticular injection of dexamethasone

Intervention Type PROCEDURE

Intraarticular injection of dexamethasone

Non-diabetic patients without steroid

Injection of normal saline

Group Type PLACEBO_COMPARATOR

Intraarticular injection of dexamethasone

Intervention Type PROCEDURE

Intraarticular injection of dexamethasone

Interventions

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Intraarticular injection of dexamethasone

Intraarticular injection of dexamethasone

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lik Hang Brian Leung, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Duchess of Kent Children Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Lik Hang Brian Leung, MBBS

Role: CONTACT

(+852) 62909986

Vincent Chan, MBBS

Role: CONTACT

Facility Contacts

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Lik Hang Brian Leung, MBBS

Role: primary

(+852) 62909986

Vincent Chan, MBBS

Role: backup

Other Identifiers

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Glucose Monitor TKR

Identifier Type: -

Identifier Source: org_study_id

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