Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000345280
Ethics application status
Not yet submitted
Date submitted
5/05/2009
Date registered
25/05/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the peri-articular injection of corticosteroid during knee replacement surgery result in reduced pain and improved knee function ?
Scientific title
The role of intra-operative peri-articular steroid injection in reducing post-operative pain and improving knee function after total knee arthroplasty: a prospective randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arthritis of the knee 4719 0
Condition category
Condition code
Surgery 5041 5041 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective randomised trial comparing pain/functional outcomes between the intra-operative peri-articular injection of either 0, 20 mg or 40 mg of triamcinolone acetonide
Intervention code [1] 4486 0
Treatment: Drugs
Comparator / control treatment
The treatment groups will be given either 20 mg or 40 mg triamcinolone acetate as a single dose intra-operatively (added to a local anaesthetic solution). The control group will not have steroid added to their local aesthetic solution (syringe is covered and volume effect is neglible) so I have still classified the control group as placebo
Control group
Placebo

Outcomes
Primary outcome [1] 5881 0
knee injury and osteoarthritis outcome score (KOOS) assessing knee pain, function and quality of life
Timepoint [1] 5881 0
12 weeks after total knee replacement
Primary outcome [2] 5882 0
knee range of motion as measured by goniometer by the treating surgeon
Timepoint [2] 5882 0
12 weeks after total knee replacement
Primary outcome [3] 5883 0
visual analogue pain scale (VAS)
Timepoint [3] 5883 0
12 weeks after total knee replacement
Secondary outcome [1] 241913 0
knee society score (KSS) measuring knee pain, range of motion, stability and function
Timepoint [1] 241913 0
12 weeks after total knee replacement
Secondary outcome [2] 241914 0
average daily standardised anagelsic requirements (oxycontin, endone, digesic) as measured by supplied diary (self reporting)
Timepoint [2] 241914 0
12 weeks after total knee replacement

Eligibility
Key inclusion criteria
patients undergoing total knee arthroplasty
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diabetes mellitus requiring insulin replacement
corticosteroid allergy
immunocompromise
chronic regional pain syndromes
workers compensation cases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subject enrolled by surgeon after excluding contra-indications and informed consent. Allocation to treatment group is performed via randomisation table by our anaesthesist (who is not involved in patient review and data collection). The syringe is covered by an opaque dressing to conceal any cloudiness that may result by the addition of corticosteroid.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation (computer generated) table was created and the patients allocated to a group in numerical order down the table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4899 0
Self funded/Unfunded
Name [1] 4899 0
Sam Chia
Country [1] 4899 0
Australia
Primary sponsor type
Individual
Name
Sam Chia
Address
PO Box 634
Waverley
NSW Australia 2024
Country
Australia
Secondary sponsor category [1] 4431 0
Individual
Name [1] 4431 0
Sam Macdessi
Address [1] 4431 0
Suite 211
Edgecliff Centre
203-233 New South Head Road
Edgecliff
NSW Australia 2027
Country [1] 4431 0
Australia
Other collaborator category [1] 661 0
Individual
Name [1] 661 0
Darren Chen
Address [1] 661 0
Suite 211
Edgecliff Centre
203-233 New South Head Road
Edgecliff
NSW Australia 2027
Country [1] 661 0
Australia
Other collaborator category [2] 662 0
Individual
Name [2] 662 0
Martin Bohm
Address [2] 662 0
Suite 211
Edgecliff Centre
203-233 New South Head Road
Edgecliff
NSW Australia 2027
Country [2] 662 0
Australia
Other collaborator category [3] 663 0
Individual
Name [3] 663 0
Greg Wernicke
Address [3] 663 0
Suite 211
Edgecliff Centre
203-233 New South Head Road
Edgecliff
NSW Australia 2027
Country [3] 663 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6962 0
Ethics committee address [1] 6962 0
Ethics committee country [1] 6962 0
Date submitted for ethics approval [1] 6962 0
06/05/2009
Approval date [1] 6962 0
Ethics approval number [1] 6962 0

Summary
Brief summary
The aim of this study is to determine if injecting corticosteroid into the knee during total knee replacement results in improved pain and function (in the short to medium term).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29569 0
Address 29569 0
Country 29569 0
Phone 29569 0
Fax 29569 0
Email 29569 0
Contact person for public queries
Name 12816 0
Sam Chia
Address 12816 0
PO Box 634
Waverley
NSW Australia 2024
Country 12816 0
Australia
Phone 12816 0
+61283070333
Fax 12816 0
Email 12816 0
skchia@tpg.com.au
Contact person for scientific queries
Name 3744 0
Sam Chia
Address 3744 0
PO Box 634
Waverley
NSW Australia 2024
Country 3744 0
Australia
Phone 3744 0
+61283070333
Fax 3744 0
Email 3744 0
skchia@tpg.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.