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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12621000630819
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
26/05/2021
Date last updated
26/05/2021
Date data sharing statement initially provided
26/05/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Radiological study to assess the stability of a polished, tapered cemented short stem used for Total Hip Arthroplasty
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Scientific title
Prospective, Monocentric Study to Assess Stability of a polished, tapered cemented short stem used for Total Hip Arthroplasty
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Secondary ID [1]
303714
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoporosis
321136
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Total Hip Arthroplasty
321969
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Hip Replacement
321970
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Condition category
Condition code
Musculoskeletal
318941
318941
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0
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Osteoporosis
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Surgery
319691
319691
0
0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. The primary goal of THA is to provide pain relief, reduce disability, improve quality of life and functional status.
Despite high implant success rates, up to 15% of patients remain dis-satisfied after surgery. This has been postulated to be due to several factors, including implant loosening (stem migration), fractures and reduced functional movement, which lead to poorer patient outcomes. This has triggered the need to experiment with various materials and develop new and improved implants, that have a higher degree of bone osseointegration, provide greater range of joint movement, stability, minimised wear and reduced risk of fracture.
A new cemented stem (known as X-ACTA short) has been developed in an attempt to overcome some of these shortcomings. The newly designed X-ACTA short stem device was recently introduced into the Australian market, however, its radiological performance in relation to stem stability and migration, is yet to be evaluated.
One method that is commonly used to measure the degree of migration is radiostereometric analysis (RSA). This technique has been shown to be a highly precise and safe technique in assessing stem migration. Given the safety and reliability of the RSA technique, the purpose of this investigation will be to assess the stability and migration of the X-ACTA cemented short stem over a 2-year period following THA surgery and determine how this correlates with patient outcomes.
All study participants will be enrolled in the trial for a period of 2-years following THA surgery. Each patient will have x-rays done at four time points (immediately post-operatively and then again at 6-months, 12-months and 2-years following surgery). Each radiological examination is expected to take 15 minutes.
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Intervention code [1]
320261
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Not applicable
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Comparator / control treatment
This is an observational study so there is no comparator arm
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
327177
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Degree of stem migration at 2-years post-surgery as determined through RSA assessment of translation and rotation around the x, y and z-axis of the femoral and acetabular components.
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Assessment method [1]
327177
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Timepoint [1]
327177
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2-years
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Secondary outcome [1]
394072
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Degree of stem migration at 6-months and 1-year post-surgery as determined through RSA assessment of translation and rotation around the x, y and z-axis of the femoral and acetabular components.
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Assessment method [1]
394072
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Timepoint [1]
394072
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6-months and 1-year
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Eligibility
Key inclusion criteria
-Patients that have had a diagnosis of end-stage primary osteoarthritis who are eligible for primary total hip arthroplasty procedure
-Patients assessed as being suitable for implant of the X-acta straight cemented short stem according to the indications for use (on-label)
-Adults aged between 18 and 75 years at the time of registration
-Ability to give informed consent
-Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with Rheumatoid Arthritis
-Patients with a history of active infection
-Patients who experienced an adverse event post-surgery deemed to be unrelated to device implant
-Patients suffering a congenital or developmental abnormality of the hip joint
-Patients who experienced a perioperative fracture
-Patients who have had prior surgery on the hip that has been operated on
-Patients with a history or are currently being treated for psychiatric illness/mental disorder or have a cognitive impairment
-Patients who are highly dependent on medical care who may be unable to give consent
-Patients with a history or are currently being treated for alcohol or drug abuse
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Descriptive analysis will be performed on qualitative variables, quantitative variables will be reported as mean, median, standard deviation, minimum and maximum. Image analysis will be performed to quantify migration of the femoral component and measured up to 2 (post-op) years. The micro-motion results will be calculated and reported as translations and rotations along the three anatomic axes. RSA measures include an estimation of subsidence and the rate of subsidence of the hip stem. RSA results will be calculated and summarised in spreadsheet format. The motion of the femoral implant will be described in relation to the marker beads placed in the proximal femur and acetabulum respectively.
Changes over time will be assessed using Analysis of Variance (ANOVA) statistical methods and other parametric tests if deemed appropriate. In case of non-normal distribution of data, a Wilcoxon signed rank test will be performed. Regression analysis will be performed for the implanted medical device migration using patient and implant related parameters in addition to radiographic findings. For all analyses, significance is set to a p-value = 0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2021
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Actual
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
308124
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Commercial sector/Industry
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Name [1]
308124
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Medacta Australia Pty Ltd
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Address [1]
308124
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Unit A1, 16 Mars Road
Lane Cove, NSW 2066
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Country [1]
308124
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Medacta Australia Pty Ltd
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Address
Unit A1, 16 Mars Road
Lane Cove, NSW 2066
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Country
Australia
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Secondary sponsor category [1]
309148
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None
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Name [1]
309148
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Address [1]
309148
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Country [1]
309148
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308110
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Ramsay Health Care Human Research Ethics Committee
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Ethics committee address [1]
308110
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Ramsay Hospital Research Foundation
2 Frederick Street
St Leonards, NSW 2065
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Ethics committee country [1]
308110
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Australia
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Date submitted for ethics approval [1]
308110
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Approval date [1]
308110
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22/01/2021
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Ethics approval number [1]
308110
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Summary
Brief summary
The X-ACTA Cemented Short Stem is a highly polished, double tapered cemented stem that has been manufactured in wrought iron stainless steel, with a Polymethyl methacrylate (PMMA) distal centraliser. This unique design is suggested to correct stem positioning and provide uniform cement distribution. The aim of this investigation is to evaluate the radiological performance of the X-ACTA Short Cemented Stem device in patients following Total Hip Arthroplasty. The hypothesis for this study is that the X-ACTA cemented short stem is non-inferior to other commercially available cemented stems in terms of stability and degree of migration.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
109574
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Dr Lachlan Milne
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Address
109574
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Orthopaedic Surgeon
Suite 419, Hollywood Consulting Centre
91 Monash Avenue, Nedlands
WA 6009
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Country
109574
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Australia
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Phone
109574
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+61 8 6150 8379
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Fax
109574
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Email
109574
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[email protected]
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Contact person for public queries
Name
109575
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Dr Lachlan Milne
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Address
109575
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Orthopaedic Surgeon
Suite 419, Hollywood Consulting Centre
91 Monash Avenue, Nedlands
WA 6009
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Country
109575
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Australia
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Phone
109575
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+61 8 6150 8379
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Fax
109575
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Email
109575
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[email protected]
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Contact person for scientific queries
Name
109576
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Dr Lachlan Milne
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Address
109576
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Orthopaedic Surgeon
Suite 419, Hollywood Consulting Centre
91 Monash Avenue, Nedlands
WA 6009
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Country
109576
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Australia
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Phone
109576
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+61 8 6150 8379
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Fax
109576
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Email
109576
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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