Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001622897
Ethics application status
Approved
Date submitted
27/04/2021
Date registered
29/11/2021
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of intra-articular botulinum toxin A versus corticosteroid injections in knee osteoarthritis: A randomised control trial
Scientific title
Efficacy and safety of intra-articular botulinum toxin A versus corticosteroid injections in knee osteoarthritis: A randomised control trial
Secondary ID [1] 304075 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 321734 0
Condition category
Condition code
Musculoskeletal 319474 319474 0 0
Osteoarthritis
Anaesthesiology 321377 321377 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group

Intra-articular injection with botulinum toxin A (100 units) reconstituted with 0.9% normal saline (5ml) - once only.

The intra-articular injection will be administered by a radiologist under ultrasound guidance.

Patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post-injection at outpatient clinic appointments. Patients will be required to complete questionnaires, an adverse event logbook and an analgesia record and bring these to each appointment.
Intervention code [1] 320406 0
Treatment: Drugs
Comparator / control treatment
Coomparator group

Intra-articular injection with triamcinolone acetonide (40mg) and ropivacaine 0.75% (5ml).

The intra-articular injection will be administered by a radiologist under ultrasound guidance - once only.

Patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post-injection at outpatient clinic appointments. Patients will be required to complete questionnaires, an adverse event logbook and an analgesia record and bring these to each appointment.
Control group
Active

Outcomes
Primary outcome [1] 327349 0
The first primary outcome is level of pain post-injection assessed using the Visual Analogue Scale.
Timepoint [1] 327349 0
Baseline data pre-injection.
Two weeks post-injection.
Six weeks post-injection.
3 months post-injection.
6 months post-injection.
12 months post-injection - primary end-point.
Primary outcome [2] 329152 0
The second primary outcome is level of function post-injection assessed using the Oxford Knee Score questionnaire.
Timepoint [2] 329152 0
Baseline data pre-injection.
Two weeks post-injection.
Six weeks post-injection.
3 months post-injection.
6 months post-injection.
12 months post-injection - primary end-point.
Primary outcome [3] 329610 0
The third primary outcome is level of function post-injection assessed using the EQ-5D-5L questionnaire.
Timepoint [3] 329610 0
Baseline data pre-injection.
Two weeks post-injection.
Six weeks post-injection.
3 months post-injection.
6 months post-injection.
12 months post-injection - primary end-point.
Secondary outcome [1] 394677 0
One secondary outcome will assess analgesia requirements post-injection by asking participants to record their typical analgesia use pre-injection and then to keep a daily log of their analgesia use post-injection.
Timepoint [1] 394677 0
Baseline data pre-injection.
Two weeks post-injection.
Six weeks post-injection.
3 months post-injection.
6 months post-injection.
12 months post-injection.
Secondary outcome [2] 401661 0
Another secondary outcome is the safety profile of each injection which will be assessed by requiring participants to complete an adverse events checklist that the researchers will compile based on the established side effects of each intra-articular (IA) injection. Participants can simply check ‘yes’ or ‘no’ for each potential side effect. There will also be a section where participants can describe any other adverse event experienced in free text.
Timepoint [2] 401661 0
Two weeks post-injection.
Six weeks post-injection.
3 months post-injection.
6 months post-injection.
12 months post-injection.

Eligibility
Key inclusion criteria
1. Age more than or equal to 40 years.
2. Diagnosis of knee OA confirmed on clinical exam and radiologically by Kellgren-Lawrence Grading Scale (Grade III or IV);
3. Symptoms present for more than or equal to 6 months; and
4. Ability to understand and participate in the trial.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age less than 40 years;
2. Any intra-articular injection within the past 12 months;
3. History of trauma to the knee within the past 12 months;
4. History of surgery to the knee within the past 12 months;
5. Neuromuscular disorders (for example, myasthenia gravis, Lambert-Eaton, amyotrophic lateral sclerosis et cetera);
6. Other knee arthropathy (for example, RA, gout et cetera);
7. Lower extremity dysfunction due to a neurological or medical cause (for example, due to a cerebrovascular accident or traumatic brain injury, diabetic neuropathy et cetera);
8. Serious coagulation disorders or anticoagulant use; and
9. Pregnancy or breastfeeding.

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)
Participants will be randomly allocated in a concealed manner to one of the two treatment groups using a standard randomisation software tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study will use an intention-to-treat analysis. All statistical tests performed will be blinded to treatment group and performed as two-sided with an a of 0.05. Baseline characteristics for both treatment groups will be reported in a table and independent samples T-tests will be performed to assess for any significant differences between the groups. The primary outcomes of pain and function will be analysed using independent sample T-tests to assess differences between groups at each data collection time point. Paired sample T-tests will be used to assess difference within each group across the data collection time points. An ANOVA test will be conducted to assess for differences in pain and function based on a sub-group analyses of Kellgren-Lawrence Grade III versus Grade IV. The secondary outcome regarding analgesia use will be performed by categorising analgesia use into opioid and non-opioid categories and then performing a conversion to a numerical rating to enable independent sample T-tests to assess for significant differences between groups. The secondary outcome regarding adverse events will be presented as a qualitative data table with events categories as ‘minor’ and ‘major’.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
1/02/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20667 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 35458 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 308459 0
Hospital
Name [1] 308459 0
Royal Perth Hospital
Country [1] 308459 0
Australia
Primary sponsor type
Individual
Name
Stephanie Babic
Address
Royal Perth Hospital
Orthopaedic Department
Victoria Square, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 309297 0
None
Name [1] 309297 0
Address [1] 309297 0
Country [1] 309297 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308415 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 308415 0
Ethics committee country [1] 308415 0
Australia
Date submitted for ethics approval [1] 308415 0
30/04/2021
Approval date [1] 308415 0
24/08/2021
Ethics approval number [1] 308415 0
RGS0000004752

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110634 0
Dr Stephanie Babic
Address 110634 0
Royal Perth Hospital
Orthopaedic Department
Victoria Square, Perth WA 6000
Country 110634 0
Australia
Phone 110634 0
+61 450908747
Fax 110634 0
Email 110634 0
[email protected]
Contact person for public queries
Name 110635 0
Stephanie Babic
Address 110635 0
Royal Perth Hospital
Orthopaedic Department
Victoria Square, Perth WA 6000
Country 110635 0
Australia
Phone 110635 0
+61 450908747
Fax 110635 0
Email 110635 0
[email protected]
Contact person for scientific queries
Name 110636 0
Stephanie Babic
Address 110636 0
Royal Perth Hospital
Orthopaedic Department
Victoria Square, Perth WA 6000
Country 110636 0
Australia
Phone 110636 0
+61 450908747
Fax 110636 0
Email 110636 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?
Deidentified individual participant data underlying the published results and the statistical code.
When will data be available (start and end dates)?
Available 3 months following publication.

Ending 5 years post-main results publication.
Available to whom?
All trial investigators will have access to the trial dataset (on a running and final basis). No external parties will have access to the trial dataset until the final dataset and statistical code is published on a public data repository e.g. Dryad.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
The final dataset and statistical code will be published on a nominated public data repository e.g. Dryad.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11511Study protocol  [email protected] The protocol has been submitted for publication to... [More Details]
11512Ethical approval    381894-(Uploaded-06-10-2021-22-58-34)-Study-related document.pdf
11513Informed consent form    381894-(Uploaded-06-10-2021-22-58-51)-Study-related document.pdf


Updated to:
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.