Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000974808
Ethics application status
Approved
Date submitted
24/05/2021
Date registered
26/07/2021
Date last updated
17/09/2023
Date data sharing statement initially provided
26/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal patient selection for physiotherapy pathways after total knee arthroplasty: the KAPPA trial
Scientific title
Investigating optimal patient selection for physiotherapy pathways after total knee arthroplasty and patient satisfaction with progress in recovery: the KAPPA trial
Secondary ID [1] 304294 0
Nil
Universal Trial Number (UTN)
Trial acronym
KAPPA (Knee Arthroplasty Physiotherapy Pathways)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing total knee replacement for Osteoarthritis 322026 0
Condition category
Condition code
Musculoskeletal 319755 319755 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised Physiotherapy Intervention
Patients will be referred to one-to-one supervised physiotherapy if:
• They are dissatisfied with the progress of their rehabilitation.
• Are assessed to have a knee flexion range of motion of less than 90 degrees.
• Are assessed to have an extension range of motion lacking 10 degrees or more.
Patients all consent to starting the trial in the self-directed group (100% allocation to self-directed) and will be referred to the one-to-one Supervised Physiotherapy intervention if any of the above criterions are met when assessed at 2 weeks, 6 weeks, and 4 months after total knee replacement surgery.
Due to the patient-centred approach of the Supervised Physiotherapy Intervention, the exercise protocol, duration, and frequency for individuals in the intervention group will be at the discretion of the treating physiotherapist. However, It is expected that all individuals undergoing supervised physiotherapy will receive a combination of manual therapy and exercise prescription from a registered physiotherapist as standard practice. Exercises and manual therapy techniques from a physiotherapist would include those targeting knee range of movement, lower limb strength and gait retraining. Patients will keep a record of the number of Supervised Physiotherapy sessions they attend.
As the first assessment timepoint is 2 weeks post operative and the final assessment time point is 4 months (16 weeks) post operative, the maximum duration for supervised physiotherapy as assessed in this trial is 14 weeks. There is no minimum, however, as stated above participants in the supervised physiotherapy group will be asked to keep a record of attendance.
Intervention code [1] 320635 0
Rehabilitation
Comparator / control treatment
A three - exercise self-directed Physiotherapy protocol (unsupervised) twice daily for the duration of the trial (4 months post operative).

The three exercises are: cycling with a set of floor pedals, a knee extension stretch and gait practice. This protocol was recently found to be an effective intervention in the first 2 weeks following total knee replacement surgery in: Sattler, L. N., Hing, W. A., & Vertullo, C. J. (2019). Pedaling-Based Protocol Superior to a 10-Exercise, Non-Pedaling Protocol for Postoperative Rehabilitation After Total Knee Replacement: A Randomized Controlled Trial. The Journal of bone and joint surgery. American volume, 101(8), 688-695. doi:10.2106/JBJS.18.00898

Due to the patient's within this trial having undergone recent total knee replacement surgery the intensity of this protocol would be considered as 'low' with patients instructed to keep their pain under 5 on a self-assessed 0 - 10 scale (10 being the worst pain, 0 being no pain) while completing the exercises.

The protocol will be completed twice daily for approximately 20 minutes duration, with a diary used to record participation in this self-directed program.
Control group
Active

Outcomes
Primary outcome [1] 327621 0
The Six-Minute Walk test (6MWT) assessed as total metres walked in six minutes.
Timepoint [1] 327621 0
2 weeks after surgery, primary endpoint.
6 weeks after surgery
4 months after surgery
Secondary outcome [1] 395953 0
Self reported satisfaction with the progress of recovery since surgery. As assessed by the following question, 'Since your knee surgery, how satisfied are you with the progress of your recovery?; Response options: Very dissatisfied, dissatisfied, neutral, satisfied or very satisfied. (5 point Likert scale)
Timepoint [1] 395953 0
2 weeks, 6 weeks and 4 months after surgery
Secondary outcome [2] 395954 0
Patient reported quality of life assessed by the Euro-Qol 5D
Timepoint [2] 395954 0
Baseline (pre-operative), and 2 weeks, 6 weeks and 4 months after surgery.
Secondary outcome [3] 395955 0
Oxford Knee Score patient reported outcome measure (PROM)
Timepoint [3] 395955 0
Baseline (pre-operative), and 2 weeks, 6 weeks and 4 months after surgery.
Secondary outcome [4] 395956 0
Knee range of motion (flexion and extension) degrees, assessed by using a goniometer
Timepoint [4] 395956 0
Baseline (pre-operative), and 2 weeks, 6 weeks and 4 months after surgery.

Eligibility
Key inclusion criteria
Patients undergoing primary total knee arthroplasty for a diagnoses of knee osteoarthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Discharge from hospital destination other than home, i.e. those who discharge to inpatient rehabilitation are not eligible.

Due to the "intention to treat" model applied to this trial, participants were initially included who met the inclusion criteria, however, if they underwent contralateral total knee arthroplasty during the trial period they were excluded,

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants will initially be allocated to the self-directed group.
At any post surgery assessment timepoint (2 weeks, 6 weeks or 4 months), a participant will be removed from the self-directed group and referred for Supervised Physiotherapy and re-allocated to the intervention group, if:
A participant responds as either very dissatisfied or dissatisfied with the progress of their recover AND/OR has a knee range of flexion motion less than 90 degrees or lacks 10 degrees or more of knee range of motion extension.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the participant characteristics, descriptive statistics for continuous data will be expressed as mean (standard deviation) or median (range) depending on data distribution, and statistical significance considered as P values <.05. Categorical variables will be summarized using counts and percentages. Univariable logistic regression analysis will be initially performed to determine the likelihood of referral to supervised physiotherapy for each patient variable. Predictor variables that were significant at 0.1 will be selected for inclusion in multivariable analysis and will undergo backward stepwise logistic regression to determine the model that best predicts the need for physiotherapy referral. Differences in mean scores between groups will also be analysed through an independent samples t test for continuous data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2021
Actual
31/01/2022
Date of last participant enrolment
Anticipated
31/10/2022
Actual
20/01/2023
Date of last data collection
Anticipated
27/02/2023
Actual
3/07/2023
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 34123 0
4217 - Benowa

Funding & Sponsors
Funding source category [1] 308454 0
University
Name [1] 308454 0
Bond University
Country [1] 308454 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive, Robina, QLD 4226.
Country
Australia
Secondary sponsor category [1] 309291 0
Charities/Societies/Foundations
Name [1] 309291 0
Knee Research Australia
Address [1] 309291 0
8-10 Carrara Street
Benowa Qld 4217
Country [1] 309291 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308409 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 308409 0
Ethics committee country [1] 308409 0
Australia
Date submitted for ethics approval [1] 308409 0
12/04/2021
Approval date [1] 308409 0
20/07/2021
Ethics approval number [1] 308409 0
LS00163

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

Contacts
Principal investigator
Name 110614 0
Dr Larissa Sattler
Address 110614 0
Bond University Institute Health and Sport
2 Promethean Way, Robina, Queensland, 4226.
Country 110614 0
Australia
Phone 110614 0
+61406537395
Fax 110614 0
Email 110614 0
[email protected]
Contact person for public queries
Name 110615 0
Larissa Sattler
Address 110615 0
Bond University Institute Health and Sport
2 Promethean Way, Robina, Queensland, 4226.
Country 110615 0
Australia
Phone 110615 0
+61406537395
Fax 110615 0
Email 110615 0
[email protected]
Contact person for scientific queries
Name 110616 0
Larissa Sattler
Address 110616 0
Bond University Institute Health and Sport
2 Promethean Way, Robina, Queensland, 4226.
Country 110616 0
Australia
Phone 110616 0
+61406537395
Fax 110616 0
Email 110616 0
[email protected]

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 data which will include individual data of 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 on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator via a secure file link to cloud based software. The Principle investigator should be contacted in writing, via email to: [email protected]


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.