NCT04902638

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

1.5 years

First QC Date

May 20, 2021

Last Update Submit

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 COMPARATOR
Procedure: Intraarticular injection of dexamethasone

Diabetic patients without steroid

PLACEBO COMPARATOR

Injection of normal saline

Procedure: Intraarticular injection of dexamethasone

Pre-diabetic patients with steroid

ACTIVE COMPARATOR
Procedure: Intraarticular injection of dexamethasone

Pre-diabetic patients without steroid

PLACEBO COMPARATOR

Injection of normal saline

Procedure: Intraarticular injection of dexamethasone

Non-diabetic patients with steroid

ACTIVE COMPARATOR
Procedure: Intraarticular injection of dexamethasone

Non-diabetic patients without steroid

PLACEBO COMPARATOR

Injection of normal saline

Procedure: Intraarticular injection of dexamethasone

Interventions

Intraarticular injection of dexamethasone

Diabetic patients with steroidDiabetic patients without steroidNon-diabetic patients with steroidNon-diabetic patients without steroidPre-diabetic patients with steroidPre-diabetic patients without steroid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lik Hang Brian Leung, MBBS

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lik Hang Brian Leung, MBBS

CONTACT

Vincent Chan, MBBS

CONTACT

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

Locations