Continuous Glucose Monitoring in Total Knee Arthroplasty With Preoperative High Dose Dexamethasone
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 26, 2021
May 1, 2021
1.5 years
May 20, 2021
May 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Hyperglycaemia time
Amount of time where patients are at hyperglycaemic state
Within 1 week of admission
Study Arms (6)
Diabetic patients with steroid
ACTIVE COMPARATORDiabetic patients without steroid
PLACEBO COMPARATORInjection of normal saline
Pre-diabetic patients with steroid
ACTIVE COMPARATORPre-diabetic patients without steroid
PLACEBO COMPARATORInjection of normal saline
Non-diabetic patients with steroid
ACTIVE COMPARATORNon-diabetic patients without steroid
PLACEBO COMPARATORInjection of normal saline
Interventions
Intraarticular injection of dexamethasone
Eligibility Criteria
You may qualify if:
- Obtained informed consent
- Adult patients (\>18 years old)
- Primary osteoarthritis of knees scheduled for unilateral TKA
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duchess of Kent Children Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lik Hang Brian Leung, MBBS
The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 26, 2021
Study Start
July 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
May 26, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share