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Trial registered on ANZCTR


Registration number
ACTRN12616001589471
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
17/11/2016
Date last updated
11/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot (Feasibility) Study of Personalised Internet-based Rehabilitation Program Incorporating Electronic Functional Monitoring after Total Knee Arthroplasty
Scientific title
Pilot (Feasibility) Study of Personalised Internet-based Rehabilitation Program Incorporating Electronic Functional Monitoring after Total Knee Arthroplasty
Secondary ID [1] 290515 0
TRI-01
Universal Trial Number (UTN)
U1111-1189-6983
Trial acronym
PRP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total knee arthroscopy recovery 300921 0
Condition category
Condition code
Musculoskeletal 300733 300733 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 300739 300739 0 0
Other physical medicine / rehabilitation
Surgery 300757 300757 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Personalised Rehabilitation Program (PRP) device consists of two non-invasive hardware devices secured or strapped above and below the knee, each consisting of an accelerometer, an SD card and a microcontroller. The devices are fitted approximately 1-4 weeks before surgery (minimum of 4 days), depending on a convenient time for the patient and the investigator to meet prior to the surgery date.

The devices are then worn continuously for 6 weeks after the surgery if the investigator deems that period to be sufficient for the rehabilitation period (e.g., there is a plateau in the outcomes being assessed), or for a further 6 weeks, which is a total of 12 weeks post surgery, if the investigator deems the patient is still rehabilitating at the 6 week post surgery visit.

These devices connect wirelessly to a dedicated Smart-device (e.g. tablet) application using Bluetooth. The application gathers and logs data before transferring the data to cloud-based storage and a software platform for review by the patient and their clinician.

The software presents both summary information as well as recommended “next best decision” to guide the patient’s medication, physiotherapy and psychological rehabilitation. The device is intended to supplied as a reusable, over-the-counter therapy aide for patients recovering from joint replacement surgeries of the knee.

The means of securing the devices to the skin may be a strap or a medically compliant adhesive (“Rocktape”) with an in-built metal pin that will allow the sensor casing to be securely attached by a magnet. This method will be easy for patients with poor eyesight and arthritic hands to use. As this securing pad is made of medically compliant material, then the only risk is a very low incidence of allergic response.

Patients consenting to total knee arthroplasty will be given a full explanation of the study.
Written consent will be required for treatment with the “Personalised Rehabilitation Program” (PRP).
Subjects will be given a tablet computer that will receive messages from their hardware devices and asks the subject questions. A program in this device will help guide the subject's preparation for surgery and their recovery after surgery. The subject will be shown how to use the tablet computer until they are comfortable with it.

The recordings of the functional parameters are de-identified and sent to a web-based ‘cloud’ file storage in Australia and then to the application via a Smart device and the data is shown on the user interface. The app on the Smart device will use the data to display updated points on the subject’s charts. These data will also trigger automatic responses from the app. If the data falls outside pre-determined limits then a message will be sent to the specialist and the nominated team (e.g. secretary, practice nurse) alerting them to this. Alternatively, if sufficient functional upgrading has been made then the option of increasing their activity will be offered automatically 2 days after the previous increase. In addition “gamification strategies” in the form of rewards (e.g. comments such as “Well done - you have reached your goal”) will be used to reward improvements in function and encourage further gains.

In addition subjects will complete some on-line questionnaires about how they are feeling and managing and also about their ability to do acts of daily living. There will be daily questions to answer on the tablet such as:

“Do you feel confident to continue with the program tomorrow?”
"How much does your pain bother you today?" (on an 11 point scale)
"How happy are you with your progress?"

Participants will complete a set of validated questionnaires using the Smart device at the scheduled in-clinic visits, and at home. Clinic visits are scheduled at baseline (4 days to 4 weeks prior to knee surgery), V1 (day prior to surgery), V2 (2 weeks post surgery), V3 (6 weeks post surgery - can be final if patient is rehabilitated) and V4 (12 weeks post surgery if required).
Intervention code [1] 296367 0
Rehabilitation
Intervention code [2] 296372 0
Treatment: Other
Intervention code [3] 296385 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300144 0
The primary outcome is success, in terms of patient satisfaction with the protocol, as assessed by a daily question:
Are you satisfied with the program? The response is YES or NO.
Timepoint [1] 300144 0
Daily from the baseline visit (device fitting) through to device removal (6 weeks or 12 weeks)
Secondary outcome [1] 329184 0
Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

Oxford Knee Score (OKS)
Timepoint [1] 329184 0
At 2 weeks post surgery and at time of device removal (6-12 weeks post surgery)
Secondary outcome [2] 329238 0
Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

WOMAC-Short Form Questionnaire
Timepoint [2] 329238 0
At 2 weeks post surgery and at time of device removal (6-12 weeks post surgery)
Secondary outcome [3] 329239 0
Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

Knee Society scoring system (2011-KS Score)
Timepoint [3] 329239 0
At 2 weeks post surgery and at time of device removal (6-12 weeks post surgery)
Secondary outcome [4] 329240 0
Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

Brief Pain Inventory (BPI)
Timepoint [4] 329240 0
At 2 weeks post surgery and at time of device removal (6-12 weeks post surgery)
Secondary outcome [5] 329241 0
Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

Depression, Anxiety Stress Scale (DASS–21)
Timepoint [5] 329241 0
At 2 weeks post surgery and at time of device removal (6-12 weeks post surgery)
Secondary outcome [6] 329242 0
Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

Pain Catastrophizing Scale (PCS)
Timepoint [6] 329242 0
At 2 weeks post surgery and at time of device removal (6-12 weeks post surgery)
Secondary outcome [7] 329243 0
Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [7] 329243 0
At 2 weeks post surgery and at time of device removal (6-12 weeks post surgery)
Secondary outcome [8] 329244 0
Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ-10)
Timepoint [8] 329244 0
At 2 weeks post surgery and at time of device removal (6-12 weeks post surgery).
Secondary outcome [9] 329304 0
Analgesic requirements throughout study period collected by logging the doses and duration of concomitant medications from baseline through to the study end.
Timepoint [9] 329304 0
Assessed at time of device removal (6-12 weeks post surgery)

Eligibility
Key inclusion criteria
Age >18 years
1. Patients considered suitable for a total knee arthroplasty by their treating surgeon
2. Patients willing to give written informed consent and to participate and comply with the requirements of the study.
3. Willing and able to use a Smart device (e.g. a tablet)
4. Has internet access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are not willing to engage with an internet-based functional monitoring and treatment program.
2. Patients unwilling to complete a series of validated psychological and functional self-report questionnaires

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)
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
Single group
Other design features
This is a single centre, prospective, pilot trial to establish if a pre- and post-operative personalised internet based protocol enhances the quality of life and outcomes after knee surgery.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is an exploratory pilot study and so this section is not relevant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/11/2016
Actual
15/11/2016
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
1/02/2019
Actual
Sample size
Target
50
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6916 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 14589 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 294930 0
Commercial sector/Industry
Name [1] 294930 0
Trifecta Pty Ltd
Country [1] 294930 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Trifecta Pty Ltd
Address
The Gallery Arcade,
445 Victoria Avenue,
Chatswood, NSW 2067
Australia
Country
Australia
Secondary sponsor category [1] 293763 0
None
Name [1] 293763 0
Address [1] 293763 0
Country [1] 293763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296305 0
Royal North Shore Public Hospital Ethics Committee
Ethics committee address [1] 296305 0
Royal North Shore Hospital,
Reserve Road,
St Leonards NSW 2065
Australia
Ethics committee country [1] 296305 0
Australia
Date submitted for ethics approval [1] 296305 0
08/07/2016
Approval date [1] 296305 0
06/10/2016
Ethics approval number [1] 296305 0

Summary
Brief summary
Total knee arthroplasty (TKA) is a very common procedure. In the USA it is the commonest surgical procedure performed in the private system over the age of 45yrs. One in five Americans over the age of 54 have had a knee replacement. Other countries are also performing increased number of TKAs. In Australia there are approximately 48,000 TKAs performed each year.

Studies have shown that up to 20% of patients are unhappy with the outcome after TKA. These patients are characterised by measures of depression and distress. Considering the expense and complication associated with TKA these figures are concerning, especially as they could be avoidable.

STUDY HYPOTHESIS; In patients undergoing a TKA, improved outcomes are associated with a combination of pre-surgical preparation (pre-habilitation) and post-operative rehabilitation using treatments that address unhelpful psychosocial factors and provide training in active pain management strategies. The delivery of these treatments can be successful achieved by an internet-based protocol incorporating electronic peripheral functional monitors and provider- and user-interfaces on a hand-held “tablet” device.

Success of this pilot study is assessed by a review of patient satisfaction with the protocol, as well the identification of any problems which can be rectified prior to the commencement of the pivotal trial.

In addition, a successful study will be shown by an improvement in function and quality of life and reduced analgesic requirements in patients treated with the Personalised Rehabilitation Program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70382 0
A/Prof Allan Molloy
Address 70382 0
Pain Management and Research Institute
Royal North Shore Hospital,
Reserve Road,
St Leonards NSW 2065
Australia
Country 70382 0
Australia
Phone 70382 0
+61411153190
Fax 70382 0
Email 70382 0
[email protected]
Contact person for public queries
Name 70383 0
Dr Myles Coolican
Address 70383 0
Director, Trifecta Brace Pty Ltd
The Gallery Arcade,
445 Victoria Avenue,
Chatswood, NSW 2067
Australia
Country 70383 0
Australia
Phone 70383 0
+61299046099
Fax 70383 0
Email 70383 0
[email protected]
Contact person for scientific queries
Name 70384 0
Dr Myles Coolican
Address 70384 0
Trifecta Brace Pty Ltd
The Gallery Arcade,
445 Victoria Avenue,
Chatswood, NSW 2067
Australia
Country 70384 0
Australia
Phone 70384 0
+61299046099
Fax 70384 0
Email 70384 0
[email protected]

No information has been provided regarding IPD availability


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.