Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000518561
Ethics application status
Approved
Date submitted
28/01/2024
Date registered
26/04/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimizing patient selection for physiotherapy pathways after knee joint replacement: a randomised controlled trial.
Scientific title
A stratified approach to outpatient physiotherapy after knee arthroplasty:
The Knee Arthroplasty Physiotherapy Pathways (KAPPA) randomised controlled trial
Secondary ID [1] 311421 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
KAPPA (Knee Arthroplasty Physiotherapy Pathways) trial
Linked study record
This study is a follow-up study of the completed research: Sattler, L. N., Walker, A. T., Kan, A. J., Hing, W. A., & Vertullo, C. J. (2024). Stratification of Outpatient Physical Therapy Following Total Knee Arthroplasty: Knee Arthroplasty Physical Therapy Pathways (KAPPA) Nonrandomized Controlled Trial. The Journal of Arthroplasty. ANZCTR registration record: ACTRN12621000974808

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing total knee arthroplasty for a primary diagnosis of Osteoarthritis 332708 0
Condition category
Condition code
Musculoskeletal 329419 329419 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those who meet the KAPPA criteria at 2 weeks post-surgery to continue self-directed rehabilitation, will be recommended to complete 3 exercises, 3 times daily, until their next KAPPA physiotherapy review at 6 weeks and 12 weeks (maximum duration of intervention 10 weeks).
The exercises are low level intensity and are commonly prescribed as independent home-exercises after total knee arthroplasty:
Knee flexion exercises in sitting (heel slides or floor bike pedals) - 5 minutes
Knee extension exercises on the bed or flat surface (sitting towel-assisted calf stretch) - 5 minutes
Walking with heel-toe gait practice - 10 minutes
A Senior Orthopaedic Physiotherapist will explain and demonstrate the self-directed exercise protocol with the participant and a instructional handout will also be provided along with a diary to record daily participation in the self-directed intervention.

Those participants who do not meet the above criteria will continue with Supervised Outpatient Physiotherapy.
Intervention code [1] 327861 0
Rehabilitation
Comparator / control treatment
Usual care: all participants will receive usual care, referral to supervised outpatient physiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 337235 0
Patient-reported function
Timepoint [1] 337235 0
Baseline and 2-, 6- (primary timepoint), and 12-weeks post-surgery
Secondary outcome [1] 431147 0
Patient-reported function and quality of life
Timepoint [1] 431147 0
Baseline and 2-, 6-, and 12-weeks post-surgery
Secondary outcome [2] 431148 0
Self-reported satisfaction with rehabilitation
Timepoint [2] 431148 0
2-, 6-, and 12-weeks post-surgery
Secondary outcome [3] 431149 0
Self-reported resilience
Timepoint [3] 431149 0
Baseline
Secondary outcome [4] 431150 0
Self-reported thoughts and feelings about pain
Timepoint [4] 431150 0
Baseline
Secondary outcome [5] 431151 0
Knee range of motion (flexion and extension)
Timepoint [5] 431151 0
Baseline and 2-, 6-, and 12-weeks post-surgery
Secondary outcome [6] 431152 0
Walking distance
Timepoint [6] 431152 0
Baseline and 2-, 6-, and 12-weeks post-surgery
Secondary outcome [7] 434310 0
Participant's self-rated health
Timepoint [7] 434310 0
Baseline and 2-, 6-, and 12-weeks post-surgery

Eligibility
Key inclusion criteria
Patients scheduled for primary unilateral TKA for a primary diagnosis of osteoarthritis at Robina Hospital.

Within the Stratified Physiotherapy Intervention group, those participants who meet the KAPPA criteria (below) will be advised to continue with a self-directed rehabilitation pathway and will not receive Supervised Physiotherapy (usual care):

• Knee flexion range of motion equal to or greater than 90 degrees.
• Knee extension range of motion not lacking in equal to or less than 10 degrees.
• Satisfied with the progress of their rehabilitation.
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 Are scheduled for contralateral TKA in <3 months.
o Are unable or unwilling to travel to physiotherapy appointments.
o Discharge to an inpatient rehabilitation facility
o Experience a peri-operative or post-operative complication or hospital readmission.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes will contain a form stating Group 1 (Usual Care) or Group 2 (Stratified Physiotherapy Intervention).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-software generated simple randomised allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this trial was calculated using SampSize software and based on the primary outcome the Oxford Knee Score, using a non-inferiority margin of 3.5.
SPSS Version 29 (IBM Corp) will be used to analyse the data and the level for statistical significance will be set at 0.05. Descriptive statistics will be expressed as mean (SD) for normally distributed continuous variables, and counts and percentages for categorical data. Normality will be checked using a combination of histograms, The differences calculated from continuous data will be both absolute and as change scores (change from baseline) at each timepoint. Longitudinal outcomes will be analysed using linear mixed effects models, to account for repeated measurements and to adjust for important baseline surgical and patient demographics as covariates. Any missing data will be modelled in the linear mixed effect models. A cost-effectiveness analysis will also be undertaken from health service and patient perspectives.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2024
Actual
15/05/2024
Date of last participant enrolment
Anticipated
4/08/2025
Actual
Date of last data collection
Anticipated
8/12/2025
Actual
Sample size
Target
90
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26084 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 41939 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 315686 0
Government body
Name [1] 315686 0
Gold Coast Hospital and Health Service
Country [1] 315686 0
Australia
Primary sponsor type
Government body
Name
Gold Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 317792 0
None
Name [1] 317792 0
Address [1] 317792 0
Country [1] 317792 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314561 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314561 0
Ethics committee country [1] 314561 0
Australia
Date submitted for ethics approval [1] 314561 0
17/01/2024
Approval date [1] 314561 0
27/03/2024
Ethics approval number [1] 314561 0
HREC/2024/QGC/104836

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

Contacts
Principal investigator
Name 132018 0
Dr William Talbot
Address 132018 0
Gold Coast University Hospital - Clinical Administration A Block, Level 6, 1 Hospital Boulevard, Southport QLD 4215
Country 132018 0
Australia
Phone 132018 0
+61 756874860
Fax 132018 0
Email 132018 0
William.Talbot2@health.qld.gov.au
Contact person for public queries
Name 132019 0
Dr Larissa Sattler
Address 132019 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina QLD 4226
Country 132019 0
Australia
Phone 132019 0
+61 755954492
Fax 132019 0
Email 132019 0
lsattler@bond.edu.au
Contact person for scientific queries
Name 132020 0
Dr Larissa Sattler
Address 132020 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina QLD 4226
Country 132020 0
Australia
Phone 132020 0
+61 755954492
Fax 132020 0
Email 132020 0
lsattler@bond.edu.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.