Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000523606
Ethics application status
Approved
Date submitted
8/03/2023
Date registered
19/05/2023
Date last updated
19/05/2023
Date data sharing statement initially provided
19/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional outcomes in patients undergoing Primary and Revision Hip Arthroplasty
Scientific title
Understanding Biomechanical and Functional Outcomes in Primary and Revision Total Hip Arthroplasty Patients
Secondary ID [1] 306148 0
None
Universal Trial Number (UTN)
Trial acronym
FOS
Linked study record
New study

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the hip 303099 0
Hip replacment surgery 303100 0
Condition category
Condition code
Musculoskeletal 302576 302576 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients undergoing total hip replacement for osteoarthritis at the Royal Adelaide Hospital, Calvary Adelaide Hospital, St Andrew's Hospital, Adelaide and Western Hospital, Adelaide will be screened for eligibility. Patients who are eligible and consent to participate will be invited to take part. In order to determine the primary outcomes of this study, participants will undergo the following assessments:
1. Two CT scans: Each patient undergoes a pre-operative and post-operative CT scan to assess changes in the hip geometry during surgery. The post-operative CT scan is a standard clinical investigation in THR cases in our institution. The pre-operative CT scan is standard clinical investigation for revision THR; but is an additional scan for primary THR patients in the trial (Ethics approved). The preoperative CT scans will be carried at Dr Jones and Partners or the Royal Adelaide Hospital; and the post-operative scans will be carried out at the respective hospital. The estimated time required to complete one CT scan is 10-15 minutes. Both CT scans do not require contrast. The scans are performed by a radiographer and reported on by a radiologist as per standard clinical practice.
2. Radiostereometric analysis: Radiostereometric analysis (RSA) is a low-dose radiographic method that uses peri-prosthetic tantalum beads as a spatial frame of reference to monitor the stability of arthroplasty implants. It is 5-8 times more sensitive to measure implant migration as compared to plain X-Rays and has been used clinically since 1972. The tantalum beads (1mm and 0.8mm) are inserted intra-operatively during surgery using a bead inserter. Nine beads (1mm) are inserted in the acetabular bone and nine beads (1mm) are inserted in the proximal femur. Three beads each (0.8mm) are inserted in the distal and proximal cement mantle. All patients will undergo a post-operative RSA examinations on day 2, 6 weeks, 3 months, 12 months and 24 months. Routine radiographs (AP pelvis, AP hip, lateral and rolled lateral views) used in standard clinical review of THR at the RAH will be taken at the same time points. In some complex cases, an additional time point of 6 months may be added, if required clinically. It takes approximately 10-15 minutes to complete RSA examination and the scans are taken by trained radiographer in collaboration with a RSA trained Research Assistant.
3. Gait assessments: In addition, patients will undergo a gait assessment at the dedictaed Gait Laboratory in the University of Adelaide Health and Medical Science Building (AHMS) pre-operatively, 6 weeks, 3 months, 6 months, 12 months and 24 months. In some complex cases, an additional time point of 6 months may be added, if required clinically. Each gait exam utilises a 10-camera Vicon Motion Capture. The software Vicon Nexus controls the cameras, calibration, capture, identification and export of data. Data from force plates (force and motion capture) and dynamic electromyography (EMG) is also integrated in the system. Fourteen EMGs will be placed on the lower limb covering the following muscle groups- Tibialis anterior, Peroneus longus, P.Brevis, Soleus, quads, gastrocnemius, Gluteus max and min, biceps femoris, semitendinosus and adductor longus to investigate the patterns of muscle activity during gait. The estimated time required to complete a gait assessment is 45 minutes. Gait assessments are conducted by Researcher Assistant staff member, graduate of Applied Science (Biomechanics and Human Movement).
4. Hip and Osteoarthritis Outcome Score (HOOS): All patients are requested to answer HOOS questionnaire which is a validated questionnaire in patients with hip osteoarthritis to measure domains of pain, stiffness, quality of life, daily living and sports/recreation. It takes 10 minutes to complete this questionnaire.
5. Activity and Sleep patterns: Patients are asked to wear a GeneActiv physical activity monitor for one week continuously following their gait assessment appointments. This will be used to monitor the patients’ activity during their daily living before surgery (baseline assessment) and following surgery to provide some objective data on the frequency of loading during recovery. The GeneActiv device is a wristwatch-type accelerometer, which can be worn 24 hours a day during all activities (excluding showering, bathing and swimming). Verbal instructions will be provided to patients, and they will be advised that it requires no user input. Accelerometers will be set to capture data at 50 Hz and uploaded data using GENEActiv PC Software version 3.1. The data will be processed in custom MATLAB software. A pre-paid envelope is provided to participants so they can post back the watch to the investigators after one week.
Intervention code [1] 321829 0
Diagnosis / Prognosis
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329094 0
To accurately measure the extent of implant migration within the first two years after surgery in patients undergoing primary and revision THA, which is predictive of later loosening using Radiostereometric Analysis (RSA).
Timepoint [1] 329094 0
Baseline (2 days post-operative), 6 weeks, 3 months, 12 months and 24 months
Primary outcome [2] 330043 0
To assess changes in hip geometry in patients undergoing elective total hip replacement using computed tomography.
Timepoint [2] 330043 0
Preoperative and 2 days post-operative
Secondary outcome [1] 401440 0
To assess gait patterns in patients undergoing THA (primary and revision) using data collected by the Vicon Motion Capture system.
Timepoint [1] 401440 0
Preoperative, 6 weeks, 3 months, 12 months and 24 months post-operative
Secondary outcome [2] 404706 0
Activity and Sleep patterns obtained from the GeneActiv device will be analysed as a composite measure. The method to determine sedentary, activity, and sleep patterns has previously been described in detail previously by our group (Thewlis D, Bahl JS, Fraysse F, Curness K, Arnold JB, Taylor M, Callary S, Solomon LB. Objectively measured 24-hour activity profiles before and after total hip arthroplasty. Bone Joint J. 2019 Apr;101-B(4):415-25).
Timepoint [2] 404706 0
Preoperative, 6 weeks, 3 months, 12 months and 24 months post-operative.
Secondary outcome [3] 404710 0
To determine patient-reported outcomes such as pain, stiffness, activities of daily living, sports and quality of life using the Hip Osteoarthritis Outcome Score (HOOS). All these domains will be retrieved from the HOOS questionnaire and results (if significant) will be presented in one graph.
Timepoint [3] 404710 0
Preoperative, 6 weeks, 3 months, 12 months and 24 months post-oeprative.

Eligibility
Key inclusion criteria
1. Patient’s undergoing primary THA for hip osteoarthritis with BMI less than or equal to 35 kg/m2
2. Patients able to undergo the required radiological examinations.
3. Patients able to undergo gait and activity analysis safely, as deemed by the surgeon.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients aged more than 80 years
2. Patients with BMI greater than 35 kg/m2
3. Patients with diagnosis other than osteoarthritis
4. Other diagnosis affecting gait (eg. osteoarthritis in other joint, cerebrovascular accident, Parkinson’s disease)
5. Severely limited mobility - cannot walk 10m for gait analysis safely unaided
6. Participants with difficulty in comprehending study protocol through written or verbal English
7. Concurrent pregnancy
8.Patients unable or unwilling to return for follow-up
9.Other significant disorder unconducive to participation, per surgeon

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Multivariate analysis will be used to assess patient and surgical factors (e.g. activity, gait and implant position) that influence early implant stability. In addition, regression analysis will be used to investigate if pre-operative gait is a predictor of pain and functional outcomes at 6 months post-operatively. Non-inferiority test will be used to identify the number of hips with acetabular component migration >1mm. Linear mixed effect modelling with post-hoc t-tests (Bonferroni adjusted) will be used to compare within group changes in gait parameters, activity and sleep patterns from pre-operative to post-operative time-points (six weeks, three months, 12 months and 24 months).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/03/2020
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
30/03/2026
Actual
Sample size
Target
130
Accrual to date
76
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20636 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 20637 0
Calvary Wakefield Hospital - Adelaide
Recruitment hospital [3] 20638 0
St Andrew's Hospital Inc - Adelaide
Recruitment hospital [4] 24216 0
Western Hospital - Henley Beach - Henley Beach
Recruitment postcode(s) [1] 35426 0
5000 - Adelaide
Recruitment postcode(s) [2] 39749 0
5022 - Henley Beach

Funding & Sponsors
Funding source category [1] 296300 0
Charities/Societies/Foundations
Name [1] 296300 0
The Royal Adelaide Hospital Research Fund
Country [1] 296300 0
Australia
Funding source category [2] 313857 0
Charities/Societies/Foundations
Name [2] 313857 0
The Hospital Research Foundation Group
Country [2] 313857 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital, Central Adelaide Local Health Network
Address
1 Port Road, Adelaide, South Australia-5000
Country
Australia
Secondary sponsor category [1] 295227 0
University
Name [1] 295227 0
The University of Adelaide
Address [1] 295227 0
AHMS Building, North Terrace, Adelaide, South Australia-5000
Country [1] 295227 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297530 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 297530 0
Ethics committee country [1] 297530 0
Australia
Date submitted for ethics approval [1] 297530 0
24/01/2020
Approval date [1] 297530 0
29/01/2020
Ethics approval number [1] 297530 0
HREC reference number: HREC/16/RAH/313 CALHN Reference number: R20160807

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

Contacts
Principal investigator
Name 74346 0
Prof Lucian Bogdan Solomon
Address 74346 0
Professor L. B. Solomon MD, PhD, FRACS
Central Adelaide Local Health Network
Dept of Orthopaedics and Trauma ( 5G581 )
Royal Adelaide Hospital
1 Port Road
Adelaide SA 5000
Country 74346 0
Australia
Phone 74346 0
+61 8 7074 1989
Fax 74346 0
+61 8 7074 6202
Email 74346 0
[email protected]
Contact person for public queries
Name 74347 0
Stuart Callary
Address 74347 0
Senior Medical Scientist
EMCR Research Fellow
Department of Orthopaedics and Trauma, Royal Adelaide Hospital
5E349
1 Port Road, Adelaide, SA 5000
Country 74347 0
Australia
Phone 74347 0
+61439080481
Fax 74347 0
Email 74347 0
[email protected]
Contact person for scientific queries
Name 74348 0
Stuart Callary
Address 74348 0
Senior Medical Scientist
EMCR Research Fellow
Department of Orthopaedics and Trauma, Royal Adelaide Hospital
5E 349, 1 Port Road, Adelaide, SA 5000
Country 74348 0
Australia
Phone 74348 0
+61439080481
Fax 74348 0
Email 74348 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14603Ethical approval  [email protected] 372822-(Uploaded-08-03-2023-16-25-39)-Study-related document.pdf



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.