Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001278628
Ethics application status
Approved
Date submitted
16/10/2023
Date registered
7/12/2023
Date last updated
3/04/2024
Date data sharing statement initially provided
7/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Knee Injection Study at St George Hospital (KISS) for the Treatment of Knee Osteoarthritis
Scientific title
A Double Blinded Three Arm Randomized Controlled Trial of Placebo, Intraarticular Corticosteroid Injection and Genicular Nerve Block for the Treatment of Symptomatic Knee Osteoarthritis
Secondary ID [1] 310794 0
None
Universal Trial Number (UTN)
Trial acronym
KISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 331774 0
Condition category
Condition code
Musculoskeletal 328515 328515 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All interventions are once-off only

Arm 1: Genicular nerve block
o Ultrasound used to localise superolateral genicular nerve (SLGN), superomedial genicular nerve (SMGN), and inferomedial genicular nerve (IMGN)
o Subcutaneous injection of a total of 1ml of 1% lignocaine at three needle entry points for comfort
o Continuous 22-gauge needle visualization to the nerve bundle using a long-axis approach to guide perineural injections of 5.7 mg celestone chronodose (1 ml) and 0.5% bupivacaine (3 ml) at three sites.
o Introduction of 3ml of normal saline into the intraarticular space of the knee joint under direct visualisation

Arm 2: Intraarticular steroid injection:
o Visualisation of the knee joint with bedside ultrasound
o Subcutaneous injection of a total of 1ml of 1% lignocaine at three points for comfort and sham, one of which is the entry point for intraarticular injection, the other two being sham injections
o Introduction of 80mg of methyl-prednisone (2ml) admixed with 1ml of 1% lignocaine to make 3mls into the intraarticular space of the knee joint under direct visualisation
Intervention code [1] 327207 0
Treatment: Drugs
Comparator / control treatment
Arm 3: Placebo

o Visualisation of the knee joint with bedside ultrasound
o Subcutaneous injection of a total of 1ml of 1% lignocaine at three points for comfort and sham
o Introduction of 3ml of normal saline into the intraarticular space under direct visualisation
Control group
Placebo

Outcomes
Primary outcome [1] 336340 0
Pain
Timepoint [1] 336340 0
Week 4 post treatment
Secondary outcome [1] 427911 0
Pain
Timepoint [1] 427911 0
Weeks 0, 2, 8, 12 post treatment
Secondary outcome [2] 427912 0
Western Ontario and McMasters Universities Osteoarthritis Index
Timepoint [2] 427912 0
Weeks 0, 2, 8, 12 post treatment
Secondary outcome [3] 427913 0
Safety
Timepoint [3] 427913 0
Weeks 0, 2, 8, 12 post treatment
Secondary outcome [4] 429325 0
Intermittent and Constant Osteoarthritis Pain
Timepoint [4] 429325 0
Weeks 0, 2, 8, 12 post treatment
Secondary outcome [5] 429326 0
Global Perceived Effect Scale
Timepoint [5] 429326 0
Weeks 0, 2, 8, 12 post treatment

Eligibility
Key inclusion criteria
• Age >= 18 years
• Able to consent
• Has readily accessible XRs of the knees of less than 12 months duration
• Knee OA as defined by ACR classification criteria
• Chronicity of pain as defined by 4 or more on VAS (1-10) on most days for at least 3 months
• Kellgren-Lawrence score of II or III
• Intraarticular steroid injection to the knee naive
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inflammatory arthritis
• Allergy to intervention compounds
• Pregnancy
• Cognitive impairment or short term memory loss
• Planned orthopaedic surgery within 6 months

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence stratified random allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size with 80% power and alpha of 0.05 to detect a 32mm difference in the VAS (based on previous studies), is36 subjects per arm. In our RCT the control arm is shared between the two interventions / comparisons, and in order to reduce the type 1 error, an alpha is 0.0375 increases the sample size per arm to 39 subjects. With a 10% dropout rate, 44 subjects per arm are needed for a total sample size of 132.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25741 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 41565 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 315033 0
Hospital
Name [1] 315033 0
Department of Rheumatology St George Hospital
Country [1] 315033 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
St George Hospital, Kensington Street, Kogarah, NSW 2217
Country
Australia
Secondary sponsor category [1] 317054 0
None
Name [1] 317054 0
Address [1] 317054 0
Country [1] 317054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313994 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 313994 0
St George Hospital, Kensington Road, Kogarah NSW 2217
Ethics committee country [1] 313994 0
Australia
Date submitted for ethics approval [1] 313994 0
15/01/2024
Approval date [1] 313994 0
01/03/2024
Ethics approval number [1] 313994 0
2023/ETH02313

Summary
Brief summary
There is currently no disease-modifying agents available for knee osteoarthritis and treatment focuses on relief of symptoms such as pain and stiffness.
There is limited placebo controlled randomised clinical trial data for a number of procedures to improve symptoms of knee osteoarthritis to improve function.
These include steroid injections into the joint and blocking the nerves that supply the joint.
These interventions have not been adequately studied against placebo.
This study will look at comparing the effectiveness and safety profile of these two technqiues agents against a shared placebo group to see if they are effective.
A further exploratory outcome is how well these interventions compare against each other if they prove effective against placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130054 0
Dr Alwin Lian
Address 130054 0
St George Hospital, Kensington Street, Kogarah 2217 NSW
Country 130054 0
Australia
Phone 130054 0
+61291132513
Fax 130054 0
Email 130054 0
[email protected]
Contact person for public queries
Name 130055 0
Alwin Lian
Address 130055 0
St George Hospital, Kensington Street, Kogarah 2217 NSW
Country 130055 0
Australia
Phone 130055 0
+61291132513
Fax 130055 0
Email 130055 0
[email protected]
Contact person for scientific queries
Name 130056 0
Alwin Lian
Address 130056 0
St George Hospital, Kensington Street, Kogarah 2217 NSW
Country 130056 0
Australia
Phone 130056 0
+61425876842
Fax 130056 0
Email 130056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
End of recruitment for 10 years
Available to whom?
researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
via secure email after approval is granted
[email protected]


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.