Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001465549
Ethics application status
Approved
Date submitted
24/10/2024
Date registered
17/12/2024
Date last updated
26/01/2025
Date data sharing statement initially provided
17/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The design and impact of a patient educational program targeted at setting realistic expectations of the outcomes of total knee arthroplasty surgery (EXTOKA).
Scientific title
The design and impact of a patient educational program targeted at setting realistic expectations of the outcomes of total knee arthroplasty surgery in patients undergone a primary total knee arthroplasty (EXTOKA)
Secondary ID [1] 313239 0
None
Universal Trial Number (UTN)
Trial acronym
EXTOKA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 335560 0
Condition category
Condition code
Musculoskeletal 332131 332131 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stage 1: Participants will be involved in alpha testing of the novel educational program being developed and evaluated in this project. This will entail participants viewing the program being developed and providing feedback regarding the material format and content. This will involve a single viewing of the educational videos developed which should last no more than 30 minutes. Following this session participants will be asked to complete a questionnaire regarding the format, content, presentation and suitability of the videos in providing information effectively to total knee replacement candidates regarding their expectations of outcomes following surgery. They will also meet face to face and have the opportunity to discuss informally the reasons for their responses to the questionnaire and provide further information to the research team regarding suggestions for potential changes or improvements to the materials provided. The information obtained will enable the research team for fine tune the educational videos so they can be then applied and assessed in the RCT in Stage 2.
Stage 2: Participants will be randomised to two study arms designed to assess the ability of the education program to impact patient expectations of surgical outcomes following total knee replacement. Arm 1: participants will be view the novel education videos, which they can view at least once and will last for up to 30 minutes, developed in Stage 1 online with access provided by a link emailed to them by the research team, in addition to any other materials they may be provided by their orthopaedic team (standard care). Arm 2: will be the control comparator group who will not be exposed to the novel education program and will be provided standard care. All participants will complete their pre-intervention study assessments 7 weeks prior to their scheduled TKA. The intervention / standard care will be provided 6 weeks prior to the TKA and post-intervention assessments undertaken 5 weeks prior to the TKA.
Intervention code [1] 329823 0
Rehabilitation
Comparator / control treatment
Stage 2, Arm 2 will be the control / comparator group for the randomization trial. if randomized to this arm, participants will undergo 'standard care' and can be exposed to any education materials provided by their treating physician or healthcare provider. This may be a discussion they have with their treating orthopaedic surgeon, printed materials or information provided by their healthcare provider, any online information they choose to view (not study-specific). They will not have access to the novel education program materials provided to Arm 1 of this trial.
Control group
Active

Outcomes
Primary outcome [1] 339706 0
Any change in patient post-surgical expectation score (within individual patients' scores), conducted prior to and following intervention exposure.
Timepoint [1] 339706 0
T1 - 1 week prior to intervention exposure and T3 - 1 week following intervention exposure.
Secondary outcome [1] 440954 0
Satisfaction with surgical outcomes.
Timepoint [1] 440954 0
T4- 24 weeks (6 months) following total knee replacement.
Secondary outcome [2] 440953 0
Fulfillment of pre-surgery expectations of surgical outcomes.
Timepoint [2] 440953 0
T3 - 1 week post intervention exposure and T4- 24 weeks (6 months) post-total knee replacement surgery.

Eligibility
Key inclusion criteria
Stage 1:
1. Have undergone a primary total knee arthroplasty (unilateral or bilateral) within the last 2 years.
2. Have the capacity to complete a series of self-reported questionnaires (presented in English).
3. Are able to provide informed consent.
Stage 2:
1. Have been identified as requiring a primary total knee arthroplasty (unilateral or bilateral) by their treating orthopaedic specialist.
2. Have the capacity to complete a series of self-reported questionnaires (presented in English).
3. Are able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage 1:
1. Have undergone a recent primary total knee replacement due to acute trauma.
2. Are unable to provide informed consent.
Stage 2:
1. Will be undergoing a primary total knee replacement due to acute trauma.
2. Have undergone previous knee replacement surgery.
3. Have had knee surgery within the preceding 6 months, have knee surgery scheduled within the next 6 months, or undergoing a revision for existing joint surgery.
4. Are unable to provide informed consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the holder of the allocation schedule who is in a central administration role within the Centre for Rehab Innovations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization will be used using a randomization table created by computerized sequence generation. If multiple healthcare providers are involved in the participant recruitment process then we will stratify participants based on healthcare provider.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power Calculation: The number of participants was selected based on previously published findings using the HSS-TKA as our primary outcome measure, to demonstrate a clinically meaningful change in the overall patient expectation score. Mancuso et al 2008 describe a clinical meaningful change in expectations to be associated with a 6-point change in transformed HSS-TKA total scores. To determine a significant difference between two groups of patients, such that alpha=0.05, Power=80%, SD=12, will require 64 patients per group. In the current study, we will enroll 75 patients per treatment arm, to allow for any potential loss of participation at the follow up time points.

Statistical plan: Descriptive and inferential statistical analyses will be undertaken to describe the characteristics of the participant cohort and to assess the research hypotheses, respectively. Clinical and demographic characteristics will be described using proportions, measures of central tendency (e.g., mean, median) and dispersion (e.g. standard deviation, interquartile range). Inferential statistics will be used to test for differences in, or associations between, outcome measures within and between groups of interest. Methods appropriate to both dependent and independent samples (e.g. t-test, ANOVA, correlation) will be utilized, including non-parametric methods for data in violation of normality and variance assumptions (e.g. Mann-Whitney U, Kruskal-Wallis). The threshold for statistical significance will be set at a p-value of .05.
To determine the impact of the health education program to change expectations, the primary outcome measure (HSS-TKA) will be measured and compared between the two treatment arms. The within patient changes of the open-ended measures of patient expectations between T0 and T2 will also be compared between the two treatment arms to further inform the efficacy of the education platform intervention. We will utilize data from all participants post-surgery to determine the association between expectation fulfillment and overall satisfaction. Activity expectation fulfillment satisfaction and overall procedure satisfaction generate ordinal datasets with associations between the two measures undertaken using Spearman’s rank correlation coefficients.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/05/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27262 0
Maitland Private Hospital - East Maitland
Recruitment hospital [2] 27261 0
Lingard Private Hospital - Merewether
Recruitment hospital [3] 27260 0
Lake Macquarie Private Hospital - Gateshead
Recruitment postcode(s) [1] 43349 0
2323 - East Maitland
Recruitment postcode(s) [2] 43348 0
2291 - Merewether
Recruitment postcode(s) [3] 43347 0
2290 - Gateshead

Funding & Sponsors
Funding source category [1] 317681 0
Charities/Societies/Foundations
Name [1] 317681 0
Hunter Medical Research Institute - nib foundation grant
Country [1] 317681 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 320003 0
None
Name [1] 320003 0
Address [1] 320003 0
Country [1] 320003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316381 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 316381 0
Ethics committee country [1] 316381 0
Australia
Date submitted for ethics approval [1] 316381 0
01/11/2024
Approval date [1] 316381 0
07/01/2025
Ethics approval number [1] 316381 0
H-2024-0312

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

Contacts
Principal investigator
Name 137714 0
Dr Karen Ribbons
Address 137714 0
Centre for Rehab Innovations, Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights, NSW, 2305
Country 137714 0
Australia
Phone 137714 0
+61 02 40420758
Fax 137714 0
Email 137714 0
[email protected]
Contact person for public queries
Name 137715 0
Karen Ribbons
Address 137715 0
Centre for Rehab Innovations, Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights, NSW, 2305
Country 137715 0
Australia
Phone 137715 0
+61 02 40420758
Fax 137715 0
Email 137715 0
[email protected]
Contact person for scientific queries
Name 137716 0
Karen Ribbons
Address 137716 0
Centre for Rehab Innovations, Hunter Medical Research Institute, Kookaburra Circuit, New Lambton Heights, NSW, 2305
Country 137716 0
Australia
Phone 137716 0
+61 02 40420758
Fax 137716 0
Email 137716 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be accessible to key stake holders and collaborative groups involved in the current study. Data can be made available to external research teams who make a request directed to the corresponding author of peer-reviewed publications. Requests will be reviewed on a case by case basis.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified evaluable data derived from stage 2 (randomized controlled trial) can be made available.

What types of analyses could be done with individual participant data?
• Data could be accessed for use in meta-analyses undertaken in a systematic review or to support development of comparable educational programs.

When can requests for individual participant data be made (start and end dates)?
From:
Data can be made available following generating the final study report and publication of study findings in peer-reviewed scientific journals which we currently forecast to be after 01/08/2027.
Data can be made available after the results have been published in a peer-reviewed scientific journal and will be available for up to 5 years after this publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data requests will need to be forwarded to the corresponding author stipulated in peer- reviewed publications with access mediated by the research team and approval granted on a case by case basis. Data requests can be made by emailing the principal investigator ([email protected]).

Are there extra considerations when requesting access to individual participant data?
No


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.