Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001044819
Ethics application status
Approved
Date submitted
3/06/2021
Date registered
9/08/2021
Date last updated
9/08/2021
Date data sharing statement initially provided
9/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Muscle strength, gait analysis and function following three different types of total hip replacements
Scientific title
Muscle strength, 3D motion analysis, and routine functional tests following three different surgical approaches of primary Total Hip Arthroplasty - a pragmatic study
Secondary ID [1] 304313 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total hip arthroplasty - anterior approach 322058 0
Total hip arthroplasty - posterior approach 322059 0
Total hip arthroplasty - lateral approach 322060 0
Condition category
Condition code
Musculoskeletal 319783 319783 0 0
Other muscular and skeletal disorders
Surgery 320278 320278 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Summary : This study is a pragmatic observational study comparing different muscle strength, 3D motion analysis parameters and performance in results obtained in commonly conducted clinical tests between three different primary total hip arthroplasty approaches over various time points including pre-operative assessment and 4 post operative assessments including 3 months, 6 month, 12 months and 24 months. The study is conducted in conjunction with Western Health Hospitals ( Melbourne, Victoria, Australia).

The all 3 surgical approaches are offered to all patients presenting to Western health by the surgeon as per normal care regardless of whether they participate in the study. The decision as to which approach is selected for patients is decided by the surgeons as per routine care and decision making process.

All patients undergoing unilateral primary THA ( By anterior , posterior or lateral approach ) who meet the eligibility criteria will be invited to participate in this study.
a) The Anterior approach is defined by the use of an inter-nervous plane between sartorius and tensor fascia latae. It involves the elevation of tensor fascia latae iliac origin and retraction of rectus femoris from its origin, along with elevation of fibres of illiocapsularis during the total hip replacement / arthroplasty.
b) The Posterior Approach : is defined by the split of gluteus maximus, division of tendons of piriformis / superior and interior gemellus and obturator internus.
c) The Lateral approach : Surgically this involves split in the line of fibres of gluteus medius and vastus lateralis, along with elevation of Gluteus Medius and minimus from the Greater Trochanter

The testing will be conduced at Swinburne university of technology (Hawthorn campus ) by a a qualified Physiotherapist ( Lakshmi Varma ) . The testing involves
1) 3D motion analysis of functional tasks like - normal walking , 40 meter fast pace walking, 30 second sit to stand, single leg balance, step up and down and change of direction
2) Isokinetic Muscle strength testing of hip and knee muscles bilaterally

Piloting at university estimates a time of 2 to 2.5 hours for each subject .
Questionnaires (Oxford hip sore , EQ-5D-5L and a general health history or physical activity record) will be used in the study for analysis and comparison. These are collected as a part of routine care for total hip replacements at Western health and done through the secure hospital system.


Intervention code [1] 320655 0
Diagnosis / Prognosis
Comparator / control treatment
The study has an age Matched healthy control meeting inclusion criteria of the study . The healthy controls will be tested at only one time point and will under go the same gait and strength tests
1) 3D motion analysis of functional tasks like - normal walking , 40 meter fast pace walking, 30 second sit to stand, single leg balance, step up and down and change of direction
2) Isokinetic Muscle strength testing of hip and knee muscles bilaterally
Control group
Active

Outcomes
Primary outcome [1] 327644 0
Objective measurements - primary outcome
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER - Hip abduction ,
Timepoint [1] 327644 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Primary outcome [2] 328134 0
3d motion analysis of function tasks -40 meter fast pace walk test
Timepoint [2] 328134 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Primary outcome [3] 328135 0
3d motion analysis of function tasks - 30 second sit to stand test ,
Timepoint [3] 328135 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [1] 396071 0
PROMS ( Patient reported outcome measures ) - EQ-5D-5L - which is routinely collected at Western health as a part of routine care for primary hip replacement
-
Timepoint [1] 396071 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [2] 397777 0
3d motion analysis of function tasks - normal walking
Timepoint [2] 397777 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [3] 397778 0
3d motion analysis of function tasks - step up and down ,
Timepoint [3] 397778 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [4] 397779 0
3d motion analysis of function tasks - , change of direction
Timepoint [4] 397779 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [5] 397780 0
3d motion analysis of function tasks - single leg balance or Trendelenburg test
Timepoint [5] 397780 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [6] 397781 0
PROMS ( Patient reported outcome measures ) - Oxford hip score - which is routinely collected at Western health as a part of routine care for primary hip replacement
Timepoint [6] 397781 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [7] 397782 0
PROMS ( Patient reported outcome measures ) - Health history questionnaire
The health history questionnaire was a questionnaire that was designed for this study and is a basic questionnaire which captures information about the number of physiotherapy sessions, rehabilitation or exercise undertaken and the physical activity the participant has been engaged in,
Timepoint [7] 397782 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [8] 398806 0
Objective measurements - primary outcome continued
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER Hip - Flexion
Timepoint [8] 398806 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [9] 398807 0
Objective measurements - primary outcome continued
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER - Hip - extension
Timepoint [9] 398807 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [10] 398808 0
Objective measurements - primary outcome continued
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER Hip -adduction ,
Timepoint [10] 398808 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [11] 398809 0
Objective measurements - primary outcome continued
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER - Hip - adduction
Timepoint [11] 398809 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [12] 398810 0
Objective measurements - primary outcome continued
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER - Hip external rotation
Timepoint [12] 398810 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [13] 398811 0
Objective measurements - primary outcome continued
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER Hip - internal rotation
Timepoint [13] 398811 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [14] 398812 0
Objective measurements - primary outcome continued
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER - knee - flexion
Timepoint [14] 398812 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement
Secondary outcome [15] 398813 0
Objective measurements - primary outcome continued
Isokinetic muscle strength using HUMAC - NORM DYNAMOMETER - knee extension
Timepoint [15] 398813 0
Pre-operative ( 4 -6 weeks ) , then at 3 months , 6 months , 12 months and 24 months following the unilateral primary total hip replacement

Eligibility
Key inclusion criteria
Healthy controls
- Over the age of 18 years.
- Consents to this study after receiving the information statement.
For Total hip arthroplasty groups ( 3 groups )
- Over the age of 18 years.
- Is a primary THA candidate at Western health hospital in one of the three THA groups
- Consents to this study after receiving the information statement.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

• Insufficient English comprehension to provide informed consent, complete simple, written questionnaires and/or understand simple, verbal instructions.
• Inability to participate in testing methods or following instructions, including PROMS, muscle strength, and functional testing.
• Have no authority or is incapable to give written consent.
• Medically unstable as determined by their respective surgeons/teams pre-operatively or post-operatively.
• Impaired cognition or in a confused state thus preventing them from being able to provide informed consent, complete simple written questionnaires and/or understand simple, verbal instructions e.g. patients with dementia, suffering an intellectual disabilities, psychological disorders, under the influence of drugs or alcohol.
• Physical impairment that prevents them from participating in muscle and functional tests e.g. acute trauma / fractures/injuries/ pain, who are bed/wheelchair bound.
• Previous history of hip or knee joint replacement

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size calculation indicated the need for 30 participants in each group, total 120 comprising 4 groups including anterior, lateral, posterior THA approaches and healthy control group.
There has been a steady increase in the THA performed at western health with 189, 221, and 255 THA patients in 2017, 2018, and 2019, respectively. It is anticipated that at least 50% of these patients will meet the inclusion/exclusion criteria and consent to participation in this study. All consecutive patients who are prospective primary total hip replacement candidates at the Western health hospital will be invited to participate in the study

The sample size was calculated using G*Power version 3.1.9.4. F-test ANOVA repeated measures with 5 measuring occasions (pre THA, and 3, 6, 12, and 24 months post THA) having alpha 0.05, power of 0.8, and effect size 0.43. Effect size was calculated using partial eta square of 0.16 which is the minimum value found in the literature to show significant effect in muscle strength and gait measurements.

All outcome measures will be treated as repeated measures analysis collected during the 5 testing visits (pre THA, and 3, 6, 12, and 24 months post THA). The repeated methods can allow valid causal inference in absence of randomization and that the between-patient variation gets separated out and this should remove confounding (by time-invariant factors). Analysis of variance and regression techniques will be applied for comparing means between groups and to build statistical models. The models will be adjusted for potential confounding factors such as age, gender, and BMI. For all tests p< 0.05 will be considered significant. Post hoc Tukey analysis will be used to identify specific significant differences.
Muscle strength outcome measure scores comparisons will be made for each variable using a two-way mixed model ANOVA with a repeated measure (timepoint) and between-subject factor (surgical approach).
Functional gait analysis dependent variables include joints kinematic, kinetics, and muscle activity. Comparisons will be made for each variable using a two-way mixed model ANOVA with a repeated measure (timepoint) and between-subject factor (surgical approach).
PROMs outcome measure scores will be analysed using multivariate regression analysis using the stepwise regression model with the PROMs at each time point as a dependent variable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/05/2021
Date of last participant enrolment
Anticipated
7/08/2023
Actual
Date of last data collection
Anticipated
14/09/2025
Actual
Sample size
Target
120
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19624 0
Western Hospital - Footscray - Footscray
Recruitment hospital [2] 19625 0
Williamstown Hospital - Williamstown
Recruitment hospital [3] 19626 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 34257 0
3011 - Footscray
Recruitment postcode(s) [2] 34258 0
3016 - Williamstown
Recruitment postcode(s) [3] 34259 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 308552 0
University
Name [1] 308552 0
Swinburne University of Technology
Country [1] 308552 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Meducta Australia
Address
a1/16 Mars Rd, Lane Cove West NSW 2066
Country
Australia
Secondary sponsor category [1] 309672 0
None
Name [1] 309672 0
Address [1] 309672 0
Country [1] 309672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308496 0
Melbourne health human research ethics committee
Ethics committee address [1] 308496 0
Ethics committee country [1] 308496 0
Australia
Date submitted for ethics approval [1] 308496 0
29/01/2020
Approval date [1] 308496 0
30/04/2020
Ethics approval number [1] 308496 0
HREC/58455/MH-2020

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

Contacts
Principal investigator
Name 110906 0
A/Prof Doa El Ansary
Address 110906 0
Swinburne University of Technology - SPW building, Federick street, Hawthorn - 3122 Victoria
Country 110906 0
Australia
Phone 110906 0
+61422036899
Fax 110906 0
Email 110906 0
[email protected]
Contact person for public queries
Name 110907 0
Lakshmi Varma
Address 110907 0
Swinburne University of Technology - SPW building, Federick street, Hawthorn - 3122 Victoria
Country 110907 0
Australia
Phone 110907 0
+61422036899
Fax 110907 0
Email 110907 0
[email protected]
Contact person for scientific queries
Name 110908 0
Lakshmi Varma
Address 110908 0
Swinburne University of Technology - SPW building, Federick street, Hawthorn - 3122 Victoria
Country 110908 0
Australia
Phone 110908 0
+61 468471114
Fax 110908 0
Email 110908 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?
Unidentifiable participant data - will be available for all data / info collected
When will data be available (start and end dates)?
Immediately following publication, no end date;
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
Data will be available for the purpose of all analysis related to this study (Ethics and SSA permitting)
How or where can data be obtained?
data ( participant unidentifiable) will be accessible once published or on request to the Principle investigator ( [email protected])


What supporting documents are/will be available?




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.