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
Scientific title
Prospective, Monocentric Study to Assess Stability of a polished, tapered cemented short stem used for Total Hip Arthroplasty
Secondary ID [1] 303714 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 321136 0
Total Hip Arthroplasty 321969 0
Hip Replacement 321970 0
Condition category
Condition code
Musculoskeletal 318941 318941 0 0
Osteoporosis
Surgery 319691 319691 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
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.
Intervention code [1] 320261 0
Not applicable
Comparator / control treatment
This is an observational study so there is no comparator arm
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327177 0
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.
Timepoint [1] 327177 0
2-years
Secondary outcome [1] 394072 0
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.
Timepoint [1] 394072 0
6-months and 1-year

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308124 0
Commercial sector/Industry
Name [1] 308124 0
Medacta Australia Pty Ltd
Country [1] 308124 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medacta Australia Pty Ltd
Address
Unit A1, 16 Mars Road
Lane Cove, NSW 2066
Country
Australia
Secondary sponsor category [1] 309148 0
None
Name [1] 309148 0
Address [1] 309148 0
Country [1] 309148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308110 0
Ramsay Health Care Human Research Ethics Committee
Ethics committee address [1] 308110 0
Ethics committee country [1] 308110 0
Australia
Date submitted for ethics approval [1] 308110 0
Approval date [1] 308110 0
22/01/2021
Ethics approval number [1] 308110 0

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

Contacts
Principal investigator
Name 109574 0
Dr Lachlan Milne
Address 109574 0
Orthopaedic Surgeon
Suite 419, Hollywood Consulting Centre
91 Monash Avenue, Nedlands
WA 6009
Country 109574 0
Australia
Phone 109574 0
+61 8 6150 8379
Fax 109574 0
Email 109574 0
lachiemilne@gmail.com
Contact person for public queries
Name 109575 0
Lachlan Milne
Address 109575 0
Orthopaedic Surgeon
Suite 419, Hollywood Consulting Centre
91 Monash Avenue, Nedlands
WA 6009
Country 109575 0
Australia
Phone 109575 0
+61 8 6150 8379
Fax 109575 0
Email 109575 0
lachiemilne@gmail.com
Contact person for scientific queries
Name 109576 0
Lachlan Milne
Address 109576 0
Orthopaedic Surgeon
Suite 419, Hollywood Consulting Centre
91 Monash Avenue, Nedlands
WA 6009
Country 109576 0
Australia
Phone 109576 0
+61 8 6150 8379
Fax 109576 0
Email 109576 0
lachiemilne@gmail.com

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.