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Trial registered on ANZCTR
Registration number
ACTRN12624001109594p
Ethics application status
Not yet submitted
Date submitted
13/08/2024
Date registered
16/09/2024
Date last updated
16/09/2024
Date data sharing statement initially provided
16/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Identifying rehabilitation associated predictors of patient satisfaction following primary total knee arthroplasty: a survey study
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Scientific title
Identifying rehabilitation associated predictors of patient satisfaction following primary total knee arthroplasty: a retrospective cohort study
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Secondary ID [1]
312409
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Nil known.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary total knee arthroplasty for a diagnosis of knee osteoarthritis
334724
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Condition category
Condition code
Musculoskeletal
331285
331285
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0
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Osteoarthritis
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Physical Medicine / Rehabilitation
331286
331286
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0
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Physiotherapy
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The condition being observed in this study are patients who have undergone a total knee arthroplasty for a primary diagnosis of osteoarthritis at Robina Hospital within the previous 6 months of the survey data collection.
Some data collected in this study will involve no direct patient involvement and will be obtained via medical records, including demographic characteristics and the frequency and type of supervised physiotherapy received following Total Knee Arthroplasty (TKA) surgery.
The patients in this study will also be directly involved in completing a 10-question survey asking them retrospectively about their experience with rehabilitation and outpatient physiotherapy following their TKA (10 minutes) as well as a self-reported functional outcome survey the Oxford Knee Score (10 minutes).
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Intervention code [1]
329378
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Satisfaction with primary total knee arthroplasty:
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Assessment method [1]
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Survey question specifically designed for this study (Likert scale):
How satisfied are you with your total knee replacement?
- Very satisfied
- Satisfied
- Neutral
- Dissatisfied
- Very dissatisfied
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Timepoint [1]
339041
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At survey completion, up to six-months following surgery.
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Secondary outcome [1]
438343
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Attendance at Outpatient Physiotherapy
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Assessment method [1]
438343
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Survey question (a) specifically designed for this study:
Did you attend Outpatient Physiotherapy in a Queensland Health clinic? (yes/no)
Survey question (b) specifically designed for this study:
Why didn’t you attend Outpatient Physiotherapy with Queensland Health?
- Time taken from other commitments (Example: Work/family)
- Pain
- Low motivation
- Transport difficulties
- Other (please describe)
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Timepoint [1]
438343
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At survey completion, up to six-months following surgery.
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Secondary outcome [2]
438344
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Lifestyle modification engagement prior to surgery
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Assessment method [2]
438344
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Survey question (a) specifically designed for this study:
Before your surgery did you participate in any of the following activities with a health care professional?
- Weight loss program
- Pain management strategies
- Mental health strategies
- Disease education
- Diabetes management
- Exercise program
- Physiotherapy
- Occupational therapy
- Other (please describe)
- I did not take part in any of the above activities prior to surgery
Survey question (b) specifically designed for this study:
Did you feel that participating in these activities before your surgery improved your outcomes after surgery?
- Yes (please describe)
- No (please describe)
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Timepoint [2]
438344
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At survey completion, up to six-months following surgery.
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Secondary outcome [3]
439119
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Patient self-reported physical function
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Assessment method [3]
439119
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Oxford Knee Score
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Timepoint [3]
439119
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At survey completion, up to six-months following surgery.
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Secondary outcome [4]
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Exercise patterns following total knee replacement arthroplasty
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Assessment method [4]
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Survey question (a) specifically designed for this study:
Did you perform exercises by yourself after your knee surgery?
1. Yes
2. No
Survey question (b) specifically designed for this study:
Were these exercises given to you by your physiotherapist?
- Yes
- No (please describe)
Survey question (c) specifically designed for this study:
On average, how often did you perform exercises for your knee?
- Multiple times a day
- Once a day
- Two times a week
- Once a week
- Less than once a week
Survey question (d) specifically designed for this study:
Some patients recover well after total knee replacement surgery without supervised physiotherapy. If you could choose, would you have rather completed your recovery exercises:
- At home, by yourself
- At a clinic supervised by a physiotherapist
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Timepoint [4]
439450
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At survey completion, up to six-months following surgery.
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Eligibility
Key inclusion criteria
Patients who have undergone a total knee arthroplasty for a primary diagnosis of osteoarthritis at Robina Hospital.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients will be excluded if they:
o Decline or unable to provide informed consent.
o Did not undergo a primary total knee arthroplasty, for example, underwent unicompartmental or revision procedures
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
Each survey question will undergo univariable and multivariable analyses to report its predictiveness of patient satisfaction following total knee arthroplasty.
Narrative and thematic analyses of open-ended survey questions will be performed.
Demographics of all participants will be reported in counts and percentages.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
8/10/2024
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Actual
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Date of last participant enrolment
Anticipated
15/10/2024
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Actual
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Date of last data collection
Anticipated
22/10/2024
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
26907
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Robina Hospital - Robina
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Recruitment postcode(s) [1]
42969
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4226 - Robina
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Funding & Sponsors
Funding source category [1]
316820
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Government body
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Name [1]
316820
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Gold Coast Hospital and Health Service
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Address [1]
316820
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Country [1]
316820
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Australia
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Primary sponsor type
Government body
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Name
Gold Coast Hospital and Health Service
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Address
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Country
Australia
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Secondary sponsor category [1]
319049
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None
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Name [1]
319049
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Address [1]
319049
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Country [1]
319049
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
315589
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Gold Coast Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
315589
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https://www.goldcoast.health.qld.gov.au/research/researchers/ethics/human-research-ethics-committee
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Ethics committee country [1]
315589
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Australia
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Date submitted for ethics approval [1]
315589
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30/09/2024
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Approval date [1]
315589
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Ethics approval number [1]
315589
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Summary
Brief summary
Despite continuous advancement in surgical technique and pain management, many patients remain dissatisfied following their total knee arthroscopy (TKA). From a patient-centred perspective, a TKA is only successful if the patient is satisfied with the outcome. In recent years, many studies have described the significance of patient expectations, level of function, post-operative pain levels, surgical techniques, and comorbidities to patient satisfaction. While current literature often mentions a correlation between patient satisfaction and rehabilitation, there is minimal comprehensive research on the topic. This study aims to identify the surgical and physiotherapy predictors of patient satisfaction during the rehabilitation process. These findings may play a role in implementing changes to clinical practice and thus, improving patient satisfaction in Gold Coast Health facilities with the potential for broader impact across QLD Health.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr William Talbot
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Address
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Gold Coast University Hospital - Clinical Administration A Block, Level 6, 1 Hospital Boulevard, Southport QLD 4215
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Country
135166
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Australia
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Phone
135166
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+61 756 874 860
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Fax
135166
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Email
135166
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[email protected]
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Contact person for public queries
Name
135167
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William Talbot
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Address
135167
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Gold Coast University Hospital - Clinical Administration A Block, Level 6, 1 Hospital Boulevard, Southport QLD 4215
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Country
135167
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Australia
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Phone
135167
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+61 756 874 860
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Fax
135167
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Email
135167
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[email protected]
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Contact person for scientific queries
Name
135168
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William Talbot
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Address
135168
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Gold Coast University Hospital - Clinical Administration A Block, Level 6, 1 Hospital Boulevard, Southport QLD 4215
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Country
135168
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Australia
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Phone
135168
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+61 756 874 860
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Fax
135168
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Email
135168
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual data underlying published results only.
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
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Available to whom?
Researchers who provide a methodologically sound proposal will be provided with data at the discretion of the Chief Investigator. Anonymous data may also be shared via a link archive where journal submission requires this.
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Available for what types of analyses?
Only to achieve the aims in the approved proposal.
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How or where can data be obtained?
Access is subject to approval by the Chief Investigator and will be provided via a secure file link to cloud-based password-protected software. The Chief Investigator should be contacted in writing, via email to:
[email protected]
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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.
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