Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000694415
Ethics application status
Approved
Date submitted
23/05/2016
Date registered
26/05/2016
Date last updated
2/08/2019
Date data sharing statement initially provided
2/08/2019
Date results information initially provided
2/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Activity Monitors to Improve Activity Level after Hip and Knee Arthroplasty
Scientific title
A Randomised Controlled Trial of Activity Monitors to Improve Activity Level after Hip and Knee Arthroplasty
Secondary ID [1] 289271 0
None
Universal Trial Number (UTN)
U1111-1183-1017
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritic knee pain 298855 0
knee arthroplasty 298856 0
osteoarthritic hip pain 298871 0
hip arthroplasty 298872 0
Condition category
Condition code
Musculoskeletal 298920 298920 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 298943 298943 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants undergoing hip or knee arthroplasty at the Mater Hospital who provide consent and meet the inclusion and exclusion criteria will be randomly assigned to the 'feedback group' or the 'no feedback group".

Arm 1 'Feedback Group': Participants will wear the Garmin Vivofit Activity Monitor on the wrist 24 hours per day for a minimum 1 week prior to surgery and 6 weeks after surgery. Prior to surgery the participants will not be able to see their daily step count on the device, On day 1 after surgery the cover on the display of the Garmin Vivofit device will be removed and participants will be able to see the number of steps they are taking, They will be given a daily step goal based on days after surgery and average steps from previous arthroplasty subjects. They will continue to wear the device for 6 week after surgery.

Arm 2 'No Feedback Group': Participants will wear the Garmin Vivofit Activity Monitor on the wrist 24 hours per day for a minimum 1 week prior to surgery and 6 weeks after surgery. Prior to surgery, and for the first 2 weeks after sugery the participants will not be able to see their daily step count on the device, On day 14 after surgery the cover on the display of the Garmin Vivofit device will be removed and participants will be able to see the number of steps they are taking, They will continue to wear the device for 6 week after surgery.

The 2 groups will be compared for mean step count.
Intervention code [1] 294818 0
Treatment: Devices
Intervention code [2] 294837 0
Rehabilitation
Comparator / control treatment
We will assess whether participants who wear the device and are given daily goals and feedback of daily step count in the first 2 weeks after arthroplasty surgery have higher activity levels than those who do not receive goals or feedback of daily step count in a randomised controlled trial.
Control group
Active

Outcomes
Primary outcome [1] 298385 0
Mean daily steps in first 2 weeks after surgery assessed with the Garmin Vivofit Activity Monitor
Timepoint [1] 298385 0
2 weeks post operatively
Primary outcome [2] 298386 0
Mean daily steps at 6 weeks after surgery with the Garmin Vivofit Activity Monitor
Timepoint [2] 298386 0
6 weeks post operatively
Secondary outcome [1] 323996 0
Mean daily steps at 6 months after surgery with the Garmin Vivofit device
Timepoint [1] 323996 0
6 months postoperatively
Secondary outcome [2] 324065 0
Knee injury and Osteoarthritis Outcome Score
Timepoint [2] 324065 0
6 months after surgery
Secondary outcome [3] 324066 0
Knee Society Scale Patient Satisfaction Score
Timepoint [3] 324066 0
6 months after surgery
Secondary outcome [4] 324067 0
Hospital length of stay (days) by review of medical records
Timepoint [4] 324067 0
6 weeks after surgery

Eligibility
Key inclusion criteria
1. TKA and THA under the care of A/Prof Justin Roe, A/Prof Leo Pinczewski, Dr Michael O’Sullivan, Dr Matthew Lyons or Dr Ben Gooden
2. Adult subject without intellectual or mental disability
3. Surgery between May 2016 and October 2016 at the Mater Hospital
4. Be willing to provide written informed consent and participate in a research program be randomised to device feedback
5. Be able to complete all the post operative assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. They have Rheumatoid Arthritis (RA) or other inflammatory disease
2. They undergo THA after an acute femoral fracture

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)
central randomization method via computer generated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisatin
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/05/2016
Date of last participant enrolment
Anticipated
31/10/2016
Actual
21/12/2016
Date of last data collection
Anticipated
Actual
30/10/2018
Sample size
Target
300
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5830 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 13279 0
2065 - Crows Nest

Funding & Sponsors
Funding source category [1] 293649 0
Other Collaborative groups
Name [1] 293649 0
North Sydney Orthopaedic and Sports Medicine Centre
Country [1] 293649 0
Australia
Primary sponsor type
Other Collaborative groups
Name
North Sydney Orthopaedic and Sports Medicine Centre
Address
Suite 2 The Mater Clinic
3 Gillies St Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 292484 0
None
Name [1] 292484 0
Address [1] 292484 0
Country [1] 292484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295087 0
St Vincent's Hospital Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 295087 0
Ethics committee country [1] 295087 0
Australia
Date submitted for ethics approval [1] 295087 0
14/01/2016
Approval date [1] 295087 0
18/04/2016
Ethics approval number [1] 295087 0
16/015

Summary
Brief summary
In this study we will use these commercially available activity trackers to monitor and encourage higher activity levels in a series of participants before and TKA or THA performed at the Mater Hospital. We will assess whether participants who wear the device and are given daily goals and feedback of daily step count in the first 2 weeks after arthroplasty surgery have higher activity levels than those who do not receive goals or feedback of daily step count in a randomised controlled trial. We will also assess and whether higher activity levels impacts hospital length of stay, participant satisfaction, participant reported outcome measures, or subsequent activity level.
Trial website
None
Trial related presentations / publications
Published in Journal of Arthroplasty 2018:
https://www.arthroplastyjournal.org/article/S0883-5403(18)30594-1/abstract
Public notes

Contacts
Principal investigator
Name 66070 0
A/Prof Justin Roe
Address 66070 0
The Mater Clinic Suite 2
3 Gillies St
Wollstonecraft NSW 2065
Country 66070 0
Australia
Phone 66070 0
+61294090500
Fax 66070 0
Email 66070 0
lsalmon@nsosmc.com.au
Contact person for public queries
Name 66071 0
Dr Lucy Salmon
Address 66071 0
The Mater Clinic Suite 2
3 Gillies St
Wollstonecraft NSW 2065
Country 66071 0
Australia
Phone 66071 0
+61 2 9409 0500
Fax 66071 0
Email 66071 0
lsalmon@nsosmc.com.au
Contact person for scientific queries
Name 66072 0
Dr Lucy Salmon
Address 66072 0
The Mater Clinic Suite 2
3 Gillies St
Wollstonecraft NSW 2065
Country 66072 0
Australia
Phone 66072 0
+61 2 9409 0500
Fax 66072 0
Email 66072 0
lsalmon@nsosmc.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.