Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000171213
Ethics application status
Approved
Date submitted
6/12/2017
Date registered
2/02/2018
Date last updated
17/12/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of Pre and Post-operative Physiotherapy using a Digital Application on Clinical and Hospital Outcomes after Total Knee Arthroplasty
Scientific title
Impact of Pre and Post-operative Physiotherapy using a Digital Application on Clinical and Hospital Outcomes after Total Knee Arthroplasty
Secondary ID [1] 293549 0
Nil known
Universal Trial Number (UTN)
U1111-1206-2479
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 305765 0
Osteoarthritis 305767 0
Condition category
Condition code
Surgery 304986 304986 0 0
Other surgery
Musculoskeletal 304990 304990 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a pre and post-operative rehabilitation program consisting of Physiotherapy exercises through a mobile electronic application.
The program will be delivered on an individual level via a telemedicine platform.
The program will be monitored and modified by one experienced orthopaedic Physiotherapist.
Participants in the interventional group will be able to contact the Physiotherapist via telephone or email at any point during the program, 6 weeks pre-operative and 6-weeks post-operative, to discuss their progress.
A participants individualised program will be implemented 6 weeks pre-operative following an initial assessment of the patient. The program will be progressed at a minimum of fortnightly.
The participants intervention will be personalised as each participant may have different areas of strengths and weaknesses and thus a personalised approach will lead to a better outcome.
This initial personalisation will occur following the initial assessment 6 weeks pre-operatively and will be based upon clinical judgement and reasoning, An individuals program may be altered at any time due to feedback from the participant, further assessment of the participant or general progression of the individuals program.
The strategies used to monitor adherence will be through the mobile electronic application where participants will be required to log exercises completed, any pain association with exercises and any further comments regarding the exercise. Participants will complete this log daily.
Intervention code [1] 299791 0
Treatment: Other
Intervention code [2] 299792 0
Rehabilitation
Comparator / control treatment
The control group will be provided current standard care prior to and after their surgery.
Standard care for the control group will be no pre-operative Physiotherapy care.
Post-operative standard care will include acute inpatient Physiotherapy prescribed by the ward Physiotherapy team. The participant will also be provided with a discharge program from the hospital Physiotherapy staff.
Control group
Active

Outcomes
Primary outcome [1] 304154 0
Length of hospital stay following Total Knee Arthroplasty
Timepoint [1] 304154 0
Upon discharge from hospital
Primary outcome [2] 304155 0
Total cost of hospital stay incurred by the patient for the procedure of a Total Knee Arthroplasty
Timepoint [2] 304155 0
Upon discharge from hospital
Primary outcome [3] 304156 0
Post-operative complications, for example deep vein thrombosis, infection, loosening of prosthesis, etc...
This outcome will be assessed and noted through clinical hospital chart entries and post-operative surgical follow-up by the attending surgeon.
Timepoint [3] 304156 0
1-week post-operative
Secondary outcome [1] 341103 0
Knee injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 341103 0
Pre-operative
6-weeks post-operative
3-months post-operative
Secondary outcome [2] 341104 0
Confidence in Mobility Scale which has been specifically designed for this study.
Timepoint [2] 341104 0
2-week post-operative
Secondary outcome [3] 341105 0
Satisfaction with surgery using a specifically designed questionnaire for this study requesting responses for questions related to a patient's confidence in performing activities of daily living and their confidence in their mobility.
For example confidence in preparing meals, taking a shower, get in/out of bed, etc...
Timepoint [3] 341105 0
6-weeks post-operative
3-months post-operative
Secondary outcome [4] 341106 0
Complications assessed via review of medical records such as deep vein thrombosis, infection, loosening of prothesis, etc...
Timepoint [4] 341106 0
Intra-operatively
1-week post-operative
6-weeks post-operative
3-months post-operative
Secondary outcome [5] 341107 0
PhysiTrack (mobile electronic application) pain
Timepoint [5] 341107 0
Daily from 6-weeks pre-operative to 6-weeks post-operative
Secondary outcome [6] 341108 0
Knee range of motion - flexion and extension.
Assessed with the use of a goniometer
Timepoint [6] 341108 0
Pre-operatively
6-weeks post-operatively
Secondary outcome [7] 341916 0
PhysiTrack (mobile electronic application) compliance
Timepoint [7] 341916 0
Daily from 6-weeks pre-operative to 6-weeks post-operative

Eligibility
Key inclusion criteria
Patients with symptomatic osteoarthritis who are candidates for a primary TKA surgery
Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow up
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not have proficiency in English
Patients with cognitive deficiencies who will not be able to utilise the digital
rehabilitation program
Patients who do not consent to participate in the study

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The number of patients required has been calculated based on power analysis. The sample size has been chosen from length of stay where a minimally important cost effective difference is 3 days, with a standard deviation of 5.8, which has been established from a pilot study we previously completed. Using a significance level (alpha) of 0.05 and a beta of 0.2, 120 total samples will be required to find the minimally significant economic difference.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/10/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
120
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 9510 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment postcode(s) [1] 18252 0
4224 - Tugun

Funding & Sponsors
Funding source category [1] 298164 0
Commercial sector/Industry
Name [1] 298164 0
360 Knee Systems
Country [1] 298164 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
360 Knee Systems
Address
Suite 3, Building 1
20 Bridge Street
Pymble
New South Wales 2073
Country
Australia
Secondary sponsor category [1] 297257 0
None
Name [1] 297257 0
Address [1] 297257 0
Country [1] 297257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299179 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 299179 0
Greenslopes Private Hospital
Newdegate Street
Greenslopes
Queensland 4120
Ethics committee country [1] 299179 0
Australia
Date submitted for ethics approval [1] 299179 0
Approval date [1] 299179 0
12/10/2017
Ethics approval number [1] 299179 0

Summary
Brief summary
The aim of the study is to determine the impact of pre and post-operative rehabilitation provided through a digital application on Clinical and Hospital Outcomes. Clinical outcome will assessed with patient reported outcome measures and knee range of motion. Hospital outcomes measured will include length of stay and inpatient and rehabilitation costs attributed to care after TKA. Patients who are selected for Total Knee Arthroplasty (TKA) and agree to participate in the study will be randomly assigned to a control or experimental group. The control group will be provided current standard care prior to and after their surgery. The experimental group will be provided a pre and post-operative rehabilitation program consisting of Physiotherapy exercises through a mobile electronic application. The program will be monitored and modified by one Physiotherapist. The experimental group will be able to contact the Physiotherapist via telephone or email at any point during the program to discuss their progress. Patients can choose to opt in and opt out of the digital rehabilitation program and will be included in the analysis on an intention to treat basis.

Prior to surgery, patient reported outcome measures will be collected to determine the patient’s pre-operative state. After surgery, various patient reported outcomes measures will be collected at two weeks, six weeks and three months to assess patient satisfaction, self-perceived confidence, pain levels and return to function. Patient reported outcome measuress will be captured via a tablet, email and / or letter, based on patient preference. Patient range of motion will be collected pre-operatively and at six weeks post-operatively by the treating surgeon. Hospital data collected will include length of stay, decision for ongoing rehabilitation and complications, which are collected as part of the hospital record. The digital application collects data on patient compliance and reported pain levels whilst using the program.

Analysis will be performed between the two groups to determine the impact of pre and post-operative digital rehabilitation on clinical and hospital outcomes after TKA surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79562 0
Dr David Liu
Address 79562 0
The Gold Coast Centre for Bone and Joint Surgery
14 Sixth Avenue
Palm Beach
QLD
4221
Country 79562 0
Australia
Phone 79562 0
+61 7 55980205
Fax 79562 0
Email 79562 0
[email protected]
Contact person for public queries
Name 79563 0
Mr Simon Carlton
Address 79563 0
360 Knee Systems
Suite 3, Building 1
20 Bridge Street
Pymble
New South Wales 2073
Country 79563 0
Australia
Phone 79563 0
+61 4 01 248 122
Fax 79563 0
Email 79563 0
[email protected]
Contact person for scientific queries
Name 79564 0
Mr Joshua Twiggs
Address 79564 0
360 Knee Systems
Suite 3, Building 1
20 Bridge Street
Pymble
New South Wales 2073
Country 79564 0
Australia
Phone 79564 0
+ 61 4 15 653 936
Fax 79564 0
Email 79564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will only be shared on a cohort - experimental/control group - basis


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6209Informed consent form    374126-(Uploaded-10-12-2019-14-10-01)-Study-related document.docx
6210Other    Patient information sheet 374126-(Uploaded-11-12-2019-10-34-36)-Study-related document.docx



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.