Trial Review

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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
Scientific title
Identifying rehabilitation associated predictors of patient satisfaction following primary total knee arthroplasty: a retrospective cohort study
Secondary ID [1] 312409 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary total knee arthroplasty for a diagnosis of knee osteoarthritis 334724 0
Condition category
Condition code
Musculoskeletal 331285 331285 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 331286 331286 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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).

Intervention code [1] 329378 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339041 0
Satisfaction with primary total knee arthroplasty:
Timepoint [1] 339041 0
At survey completion, up to six-months following surgery.
Secondary outcome [1] 438343 0
Attendance at Outpatient Physiotherapy
Timepoint [1] 438343 0
At survey completion, up to six-months following surgery.
Secondary outcome [2] 438344 0
Lifestyle modification engagement prior to surgery
Timepoint [2] 438344 0
At survey completion, up to six-months following surgery.
Secondary outcome [3] 439119 0
Patient self-reported physical function
Timepoint [3] 439119 0
At survey completion, up to six-months following surgery.
Secondary outcome [4] 439450 0
Exercise patterns following total knee replacement arthroplasty
Timepoint [4] 439450 0
At survey completion, up to six-months following surgery.

Eligibility
Key inclusion criteria
Patients who have undergone a total knee arthroplasty for a primary diagnosis of osteoarthritis at Robina Hospital.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/10/2024
Actual
Date of last participant enrolment
Anticipated
15/10/2024
Actual
Date of last data collection
Anticipated
22/10/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26907 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 42969 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 316820 0
Government body
Name [1] 316820 0
Gold Coast Hospital and Health Service
Country [1] 316820 0
Australia
Primary sponsor type
Government body
Name
Gold Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 319049 0
None
Name [1] 319049 0
Address [1] 319049 0
Country [1] 319049 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315589 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 315589 0
Ethics committee country [1] 315589 0
Australia
Date submitted for ethics approval [1] 315589 0
30/09/2024
Approval date [1] 315589 0
Ethics approval number [1] 315589 0

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

Contacts
Principal investigator
Name 135166 0
Dr William Talbot
Address 135166 0
Gold Coast University Hospital - Clinical Administration A Block, Level 6, 1 Hospital Boulevard, Southport QLD 4215
Country 135166 0
Australia
Phone 135166 0
+61 756 874 860
Fax 135166 0
Email 135166 0
William.Talbot2@health.qld.gov.au
Contact person for public queries
Name 135167 0
William Talbot
Address 135167 0
Gold Coast University Hospital - Clinical Administration A Block, Level 6, 1 Hospital Boulevard, Southport QLD 4215
Country 135167 0
Australia
Phone 135167 0
+61 756 874 860
Fax 135167 0
Email 135167 0
William.Talbot2@health.qld.gov.au
Contact person for scientific queries
Name 135168 0
William Talbot
Address 135168 0
Gold Coast University Hospital - Clinical Administration A Block, Level 6, 1 Hospital Boulevard, Southport QLD 4215
Country 135168 0
Australia
Phone 135168 0
+61 756 874 860
Fax 135168 0
Email 135168 0
William.Talbot2@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual data underlying published results only.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
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.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
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: William.Talbot2@health.qld.gov.au


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.