Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001084572p
Ethics application status
Not yet submitted
Date submitted
20/08/2024
Date registered
6/09/2024
Date last updated
6/09/2024
Date data sharing statement initially provided
6/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does physical and psychological state before surgery impact the length of hospital stay and pain medication use after total knee replacement?
Scientific title
The correlation between pre-operative function and psychological state on post-operative outcomes undergoing total knee arthroplasty.
Secondary ID [1] 312517 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee arthroplasty for a primary diagnosis of osteoarthritis 334384 0
Condition category
Condition code
Anaesthesiology 331025 331025 0 0
Pain management
Surgery 331026 331026 0 0
Surgical techniques
Musculoskeletal 331027 331027 0 0
Osteoarthritis
Mental Health 331028 331028 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Some data collected in this study will involve no direct patient involvement and will be obtained via medical records, including demographic characteristics and admission details including length of hospital stay (days) and analgesia consumption. The patients in this study will also be directly involved in completing physical assessments and surveys before their surgery, these include:
Knee Range of motion - 2 minutes
Walking distance - 2 minutes
EQ5D Survey of self-reported function - 10 minutes
Oxford Knee Score Survey of self-reported function - 10 minutes
Brief resilience Survey - 5 minutes
Pain Catastrophising Scale Survey - 10 minutes

All data will be collected by a registered physiotherapist. Observational period is from two weeks prior to surgery to discharge from the acute hospital setting following surgery.
Intervention code [1] 329043 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338801 0
Post-surgery length of stay (days)
Timepoint [1] 338801 0
After discharge from hospital
Primary outcome [2] 338802 0
Pro re nata analgesia use post surgery until discharge from hospital
Timepoint [2] 338802 0
After discharge from hospital
Secondary outcome [1] 437518 0
Baseline analgesia
Timepoint [1] 437518 0
After discharge from hospital

Eligibility
Key inclusion criteria
Patients scheduled for primary unilateral Total Knee Arthroplasty (TKA) for a primary diagnosis of osteoarthritis at Robina Hospital.
Patients who consent to participate in the trial
Patients who are able to participate in the assessment of study outcomes
Minimum age
18 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 Discharge to an inpatient rehabilitation facility
o Experience a peri-operative or post-operative complication or hospital readmission.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
15/03/2025
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26854 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 42915 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 316952 0
Other
Name [1] 316952 0
Funded in kind (Dr Larissa Sattler - Bond University and Dr William Talbot - Gold Coast Hospital and Health Service)
Country [1] 316952 0
Australia
Primary sponsor type
Government body
Name
Gold Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 319500 0
None
Name [1] 319500 0
Address [1] 319500 0
Country [1] 319500 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315693 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 315693 0
Ethics committee country [1] 315693 0
Australia
Date submitted for ethics approval [1] 315693 0
15/09/2024
Approval date [1] 315693 0
Ethics approval number [1] 315693 0

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

Contacts
Principal investigator
Name 135526 0
Dr William Talbot
Address 135526 0
Gold Coast University Hospital - Clinical Administration A Block, Level 6, 1 Hospital Boulevard, Southport QLD 4215
Country 135526 0
Australia
Phone 135526 0
+61 756874860
Fax 135526 0
Email 135526 0
William.Talbot2@health.qld.gov.au
Contact person for public queries
Name 135527 0
Larissa Sattler
Address 135527 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina QLD 4226
Country 135527 0
Australia
Phone 135527 0
+61 07 55954492
Fax 135527 0
Email 135527 0
lsattler@bond.edu.au
Contact person for scientific queries
Name 135528 0
Larissa Sattler
Address 135528 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina QLD 4226
Country 135528 0
Australia
Phone 135528 0
+61 07 5595 4492
Fax 135528 0
Email 135528 0
lsattler@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.