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
About this trial
This is an interventional supportive care trial for Diabetes
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
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
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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