Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001000190
Ethics application status
Approved
Date submitted
20/06/2019
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding and predicting recovery in patients undergoing total knee replacement
Scientific title
Development of an advanced clinical decision-making support tool for the delivery of efficient, personalised rehabilitation for patients undergoing total knee arthroplasty (TKA)
Secondary ID [1] 298563 0
None
Universal Trial Number (UTN)
U1111-1235-7747
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty (TKA) 313391 0
knee replacement 313517 0
Condition category
Condition code
Musculoskeletal 311824 311824 0 0
Osteoarthritis
Musculoskeletal 311950 311950 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intervention: Total knee arthroplasty
Patients will provide written consent to take part in this study. Patients will complete health and psycho-social questionnaires and take part in physical assessments prior to surgery and three months post-surgery. Additional demographic and medical information will be extracted from health records.
Observation will take place at 2 time points: Around 4 weeks prior to surgery and then again at 3 months post surgery.
Intervention code [1] 314812 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320606 0
Goal Achievement as measured by satisfaction questionnaire and Value Living Scale
Timepoint [1] 320606 0
3 months post surgery
Primary outcome [2] 320607 0
Functional mobility and pain as measured by: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [2] 320607 0
Up to 4 weeks presurgery and 3 months post surgery
Primary outcome [3] 320608 0
Quality of Life as measured on the SF-12
Timepoint [3] 320608 0
Up to 4 weeks pre-surgery and 3 months post surgery
Secondary outcome [1] 371805 0
Functional performance as measured by independent and composite measures of performance on the Timed Up and Go test, walking speed, grip strength and the 30-second chair stand test.
Timepoint [1] 371805 0
Up to 4 weeks pre-surgery and three months post-surgery.
Secondary outcome [2] 371806 0
Depression, anxiety, and stress as measured on the Depression, Anxiety and Stress Scale (DASS 21)
Timepoint [2] 371806 0
Up to 4 weeks pre-surgery and three months post-surgery.
Secondary outcome [3] 371809 0
Perceived intensity of pain as measured by the Pain Catastrophizing Questionnaire (PCS)
Timepoint [3] 371809 0
Up to 4 weeks pre-surgery
Secondary outcome [4] 372182 0
The capacity to recover from difficulties as measured by the brief resilience scale
Timepoint [4] 372182 0
Up to 4 weeks pre-surgery

Eligibility
Key inclusion criteria
• Ability to complete the patient reported outcome measures (questionnaires),
• Undergoing primary total knee replacement (bilateral or unilateral)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Having primary total knee replacement due to trauma
• Previous knee surgery within the past 6 months
• Planned knee surgery within the next 12 months
• Not having the capacity to provide informed consent to the research.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Primary outcome: The tool to be developed will use Bayesian machine learning estimation techniques to predict patient outcomes based on the information collected both prior to and shortly after the surgery. For this application, the information or data that is obtained about each patient is given by the variable Y, and theta is used to represent the prediction of recovery outcomes at three months post-surgery. Initially, a prior distribution of possible outcomes for the patient based on previous intuition is determined and is denoted by p(theta). This distribution will be continually updated according to the data collected about the individual. This is achieved by using a proposed model, denoted by p(Y|theta) that describes the effect that certain recovery outcomes would have on observing the data. The resulting distribution is denoted p(theta|Y) and represents the predicted distribution of recovery outcomes at three months post-surgery, given the evidence extracted from the collected data. The fundamental relationship that connects these expressions is referred to as Bayes' theorem.

Essentially, Bayes' theorem uses the initial understanding or belief about the outcomes of the patient along with collected information and data, to yield an improved estimate of the best possible rehabilitative outcomes.
Secondary outcome: Univariate and multivariate logistic regression will be performed to assess relationships between outcome variables. Predictor variables will be assessed for multicollinearity. Significance will be assessed at the 0.05 level.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14035 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [2] 14036 0
Kareena Private Hospital - Caringbah
Recruitment postcode(s) [1] 26825 0
2290 - Gateshead
Recruitment postcode(s) [2] 26826 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 303102 0
Charities/Societies/Foundations
Name [1] 303102 0
Ramsay Hospital Research Foundation
Address [1] 303102 0
Level 8, 154 Pacific Highway
St Leonards, NSW 2065
Country [1] 303102 0
Australia
Primary sponsor type
University
Name
Centre for Rehab Innovations, University of Newcastle
Address
University Drive
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 303092 0
None
Name [1] 303092 0
Address [1] 303092 0
Country [1] 303092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303647 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 303647 0
University Drive
Callaghan NSW 2308
Ethics committee country [1] 303647 0
Australia
Date submitted for ethics approval [1] 303647 0
02/04/2019
Approval date [1] 303647 0
21/06/2019
Ethics approval number [1] 303647 0
H-2019-0109

Summary
Brief summary
Rehabilitation is an important factor that improves recovery from total knee arthroplasty (knee replacement surgery). However, no clinical guidelines currently exist to inform recovery pathways following surgery, likely due to the lack of evidence to suggest who may benefit from rehabilitation, when and where this service should be delivered, and what services should be provided. This has led to an inconsistent approach to rehabilitation.
The aim of this study is to develop a recovery pathways stratification tool based on a comprehensive evaluation of individual patient data, including physical performance assessments and physical, social, and mental health evaluations. Ultimately this tool will allow a personalised approach to refer patients to rehabilitation pathways based on their own needs and circumstances.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94386 0
Prof Michael Nilsson
Address 94386 0
Centre for Rehab Innovations
University of Newcastle
University Drive, Callaghan
New South Wales, 2308

Country 94386 0
Australia
Phone 94386 0
+61 02 4042 0570
Fax 94386 0
Email 94386 0
michael.nilsson@newcastle.edu.au
Contact person for public queries
Name 94387 0
Mrs Lucy Bailey
Address 94387 0
Centre for Rehab Innovations
University of Newcastle
University Drive, Callaghan
New South Wales, 2308
Country 94387 0
Australia
Phone 94387 0
+61 02 4042 0570
Fax 94387 0
Email 94387 0
lucy.bailey@newcastle.edu.au
Contact person for scientific queries
Name 94388 0
Prof Michael Nilsson
Address 94388 0
Centre for Rehab Innovations
University of Newcastle
University Drive, Callaghan
New South Wales, 2308

Country 94388 0
Australia
Phone 94388 0
+61 02 4042 0570
Fax 94388 0
Email 94388 0
michael.nilsson@newcastle.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
No public sharing of data is planned. Controlled access to data may be provided after study completion.
What supporting documents are/will be available?
No other documents available
Summary results
No Results