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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?
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Scientific title
The correlation between pre-operative function and psychological state on post-operative outcomes undergoing total knee arthroplasty.
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Secondary ID [1]
312517
0
None
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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:
Total knee arthroplasty for a primary diagnosis of osteoarthritis
334384
0
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Condition category
Condition code
Anaesthesiology
331025
331025
0
0
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Pain management
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Surgery
331026
331026
0
0
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Surgical techniques
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Musculoskeletal
331027
331027
0
0
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Osteoarthritis
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Mental Health
331028
331028
0
0
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Anxiety
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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
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.
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Intervention code [1]
329043
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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]
338801
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Post-surgery length of stay (days)
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Assessment method [1]
338801
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Hospital Integrated electronic medical record (ieMR)
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Timepoint [1]
338801
0
After discharge from hospital
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Primary outcome [2]
338802
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Pro re nata analgesia use post surgery until discharge from hospital
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Assessment method [2]
338802
0
Hospital Integrated electronic medical record (ieMR)
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Timepoint [2]
338802
0
After discharge from hospital
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Secondary outcome [1]
437518
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Baseline analgesia
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Assessment method [1]
437518
0
Hospital Integrated electronic medical record (ieMR)
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Timepoint [1]
437518
0
After discharge from hospital
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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
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Minimum age
18
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 Discharge to an inpatient rehabilitation facility
o Experience a peri-operative or post-operative complication or hospital readmission.
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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
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
1/03/2025
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Actual
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Date of last data collection
Anticipated
15/03/2025
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Actual
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Sample size
Target
84
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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]
26854
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Robina Hospital - Robina
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Recruitment postcode(s) [1]
42915
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4226 - Robina
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Funding & Sponsors
Funding source category [1]
316952
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Other
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Name [1]
316952
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Funded in kind (Dr Larissa Sattler - Bond University and Dr William Talbot - Gold Coast Hospital and Health Service)
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Address [1]
316952
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Country [1]
316952
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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]
319500
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None
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Name [1]
319500
0
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Address [1]
319500
0
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Country [1]
319500
0
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
315693
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Gold Coast Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
315693
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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]
315693
0
Australia
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Date submitted for ethics approval [1]
315693
0
15/09/2024
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Approval date [1]
315693
0
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Ethics approval number [1]
315693
0
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Summary
Brief summary
Within Gold Coast Health all patients the average length of stay for patients who have their knee joint replaced (total knee arthroplasty) is between three to five days, however, variation exists. During the stay, PRN analgesics are frequently used by the patients to relieve post operative pain. This study aims to investigate the correlation between pre-operative factors, such as resilience score and physical function on post operative length of stay/PRN analgesia use. Thus, it may provide opportunities for clinicians to optimise patient’s pre operative status, which would have the potential to reduce both length of hospital stay and PRN analgesia use.
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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
135526
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Dr William Talbot
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Address
135526
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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
135526
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Australia
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Phone
135526
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+61 756874860
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Fax
135526
0
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Email
135526
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[email protected]
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Contact person for public queries
Name
135527
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Larissa Sattler
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Address
135527
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Bond Institute of Health and Sport, 2 Promethean Way, Robina QLD 4226
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Country
135527
0
Australia
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Phone
135527
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+61 07 55954492
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Fax
135527
0
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Email
135527
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[email protected]
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Contact person for scientific queries
Name
135528
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Larissa Sattler
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Address
135528
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Bond Institute of Health and Sport, 2 Promethean Way, Robina QLD 4226
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Country
135528
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Australia
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Phone
135528
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+61 07 5595 4492
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Fax
135528
0
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Email
135528
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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