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

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04902638
Collaborator
(none)
100
1
6
18
5.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intraarticular injection of dexamethasone
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Continuous Glucose Monitoring in Total Knee Arthroplasty With Preoperative High Dose Dexamethasone: A Randomized Controlled Study
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Hyperglycaemia time [Within 1 week of admission]

    Amount of time where patients are at hyperglycaemic state

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duchess of Kent Children Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04902638
Other Study ID Numbers:
  • Glucose Monitor TKR
First Posted:
May 26, 2021
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2021