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

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Unknown

Conditions

Diabetes
Knee Osteoarthritis

Treatments

Procedure: Intraarticular injection of dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT04902638
Glucose Monitor TKR

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 6 patient groups, including a placebo group

Diabetic patients with steroid
Active Comparator group
Treatment:
Procedure: Intraarticular injection of dexamethasone
Diabetic patients without steroid
Placebo Comparator group
Description:
Injection of normal saline
Treatment:
Procedure: Intraarticular injection of dexamethasone
Pre-diabetic patients with steroid
Active Comparator group
Treatment:
Procedure: Intraarticular injection of dexamethasone
Pre-diabetic patients without steroid
Placebo Comparator group
Description:
Injection of normal saline
Treatment:
Procedure: Intraarticular injection of dexamethasone
Non-diabetic patients with steroid
Active Comparator group
Treatment:
Procedure: Intraarticular injection of dexamethasone
Non-diabetic patients without steroid
Placebo Comparator group
Description:
Injection of normal saline
Treatment:
Procedure: Intraarticular injection of dexamethasone

Trial contacts and locations

1

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Central trial contact

Vincent Chan, MBBS; Lik Hang Brian Leung, MBBS

Data sourced from clinicaltrials.gov

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