Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001225606
Ethics application status
Approved
Date submitted
29/09/2023
Date registered
28/11/2023
Date last updated
28/11/2023
Date data sharing statement initially provided
28/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Waiting time: Does it affect the physical functioning of people waiting for a total joint replacement?
Scientific title
Waiting time: Does it affect the physical functioning of people waiting for a total joint replacement?
Secondary ID [1] 310633 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary hip replacement 331514 0
Primary knee replacement 331515 0
Condition category
Condition code
Musculoskeletal 328246 328246 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will investigate people who are on the public waiting list for primary total hip and knee replacements. Data will include walking gait parameters, patient-reported outcome measures (questionnaires) and activity data. Data will be collected at one timepoint (pre-operative with respect to their date of referral onto the waiting list) during an appointment at the Royal Adelaide Hospital, which will take approximately 30-45 minutes. The appointment will consist of a series of questionnaires, body measurements and assessment of gait using wearable sensors and an instrumented treadmill.

This study will be separated into 3 aims: 1) Test the reliability of the study methods using wearable sensors and an instrumented treadmill, 2) Test the validity of the study methods compared to the current reference standard of optical motion capture, 3) investigate whether associations exist between 1) symptom duration and 2) waiting time and walking gait.

The gait capture system used at the RAH, utilises a split belt instrumented treadmill which allows individual force profiles of each leg of the participant. This allows us to determine whether the participant is favouring one limb over the other by how much force is exerted. This system also uses Inertial Measurement Units (IMUs), which have an accelerometer, magnetometer, and gyroscope. This allow the collection of gait data without the use of specialised laboratories and in settings where gait had previously not been able to be captured in, such as at home and outdoors.

The key differences between Optical Motion capture (MoCap) and the proposed gait analysis methodology (IMUs and treadmill) is that less equipment is needed and the wearable sensors methodology can be used in other settings. Previous comparison studies using MoCap and IMUs have shown agreement in the gait data they collect. MoCap also requires a specialised laboratory with all the equipment set up, thus making the use of IMUs for gait analysis cheaper and less time consuming to perform. Another key difference is with the use of the treadmill, which allows the collection of multiple gait cycles of data compared to MoCap's use of force platforms.
Intervention code [1] 327031 0
Not applicable
Comparator / control treatment
Control group - Same group of participants used for MoCap (a sub group)

Optical Motion capture (MoCap) is the current reference standard for collecting gait data. It involves a 10-camera Vicon Nexus system and 47 retroreflective markers to collect gait in a specialised facility in the University of Adelaide. We will be collecting gait data using MoCap for a small sample of participants to test the validity and repeatability of the methodology used in the RAH facility. This session will take no more than 30 minutes and will immediately follow an appointment at the RAH.
Control group
Active

Outcomes
Primary outcome [1] 336113 0
Walking Gait parameters including spatiotemporal, ground reaction forces, and kinematic measures.

All parameters will be assessed as a composite primary outcome.
Timepoint [1] 336113 0
Pre-operatively with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [1] 426876 0
Physical Activity levels
Timepoint [1] 426876 0
Pre-operatively with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [2] 426878 0
Physical activity levels for the elderly.
Timepoint [2] 426878 0
Pre-operatively with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [3] 428315 0
General health status
Timepoint [3] 428315 0
Pre-op with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [4] 428316 0
Mental health status
Timepoint [4] 428316 0
Pre-op with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [5] 428317 0
Knee functionality and status
Timepoint [5] 428317 0
Pre-op with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [6] 428318 0
Hip functionality and status
Timepoint [6] 428318 0
Pre-op with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [7] 428319 0
Assess potential symptoms of sarcopenia
Timepoint [7] 428319 0
Pre-op with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [8] 428320 0
Simple nutritional status
Timepoint [8] 428320 0
Pre-op with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [9] 428321 0
Repeatability of the methodology at the RAH (wearable sensors and instrumented treadmill)
Timepoint [9] 428321 0
Pre-op with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op
Secondary outcome [10] 428322 0
Validity of the RAH methodology (wearable sensors and instrumented treadmill)
Timepoint [10] 428322 0
Pre-op with respect to the participant's referral date onto the orthopaedic waiting list. e.g. 200 days on the waiting list pre-op

Eligibility
Key inclusion criteria
People aged 18 years and over.
People on the orthopaedic surgical waiting list at the RAH for total knee arthroplasty (TKA) or total hip arthroplasty (THA).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who are unable to provide consent (written and spoken).
People who are unable to bring a family member to interpret for them if they are unable to understand written and spoken English
People with pre-existing neuromuscular disorders
People with pre-existing traumatic brain injury
Women who are pregnant
People who cannot walk or stand unaided will be excluded from gait analysis but will be eligible to participate in the other study components i.e., PROMs and wrist-worn accelerometer watch.
Participants that are deemed high risk by the falls risk for older people in the community (FROP-Com) screening tool (attached) will be excluded, however they can still participate in other study components.
People with BMI indexes greater than 35 kg/m2 will be excluded from the MoCap data collection.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
For aim 1: we will be using intraclass correlation coefficient (ICC) to test for test-retest reliability.

For aim 2: We will use mean differences, paired t-tests, and Bland-Altman plots to assess the validity of the methodology (bias and 95% confidence intervals).

For aim 3: We will be obtaining basic statistics (mean and standard deviation) for waiting time, symptom duration, gait parameters, and patient reported outcome measures. We then will use Principle Component Regression (PCR) to explore the relationship between measured parameters and waiting time and symptom duration.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/11/2023
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
8/11/2024
Actual
Sample size
Target
250
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25550 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 41371 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 314849 0
University
Name [1] 314849 0
The University of Adelaide
Country [1] 314849 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide, Adelaide, South Australia, 5005
Country
Australia
Secondary sponsor category [1] 316906 0
None
Name [1] 316906 0
Address [1] 316906 0
Country [1] 316906 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313850 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 313850 0
Ethics committee country [1] 313850 0
Australia
Date submitted for ethics approval [1] 313850 0
21/09/2023
Approval date [1] 313850 0
09/10/2023
Ethics approval number [1] 313850 0
18495

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

Contacts
Principal investigator
Name 129550 0
Prof Bogdan Solomon
Address 129550 0
Department of Orthopaedic & Trauma, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 129550 0
Australia
Phone 129550 0
+61 4 3889 1549
Fax 129550 0
Email 129550 0
[email protected]
Contact person for public queries
Name 129551 0
Dominic Thewlis
Address 129551 0
The University of Adelaide, Level 7, 4 North Terrace, Adelaide SA 5000
Country 129551 0
Australia
Phone 129551 0
+61 8 8313 7096
Fax 129551 0
Email 129551 0
[email protected]
Contact person for scientific queries
Name 129552 0
Dominic Thewlis
Address 129552 0
The University of Adelaide, Level 7, 4 North Terrace, Adelaide SA 5000
Country 129552 0
Australia
Phone 129552 0
+61 8 8313 7096
Fax 129552 0
Email 129552 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


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.