Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000233426
Ethics application status
Approved
Date submitted
21/01/2025
Date registered
31/03/2025
Date last updated
31/03/2025
Date data sharing statement initially provided
31/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-centre, prospective study to evaluate the M-Finity femoral Stem in patients undergoing Total Hip Arthroplasty
Scientific title
A multi-centre, prospective study to evaluate the M-Finity femoral Stem in patients undergoing Total Hip Arthroplasty
Secondary ID [1] 313772 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Osteoarthritis 336387 0
Total Hip Arthroplasty 336388 0
Condition category
Condition code
Musculoskeletal 332911 332911 0 0
Osteoarthritis
Surgery 332912 332912 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. Patients who are planned to undergo THA surgery and fit the eligibility criteria will be considered for enrolment in this study. The M-Finity femoral stem is an implant designed for THA. The implant is designed to provide a good fit and stability. Each participant will receive the new Medacta M-Finity femoral stem device together with a compatible Medacta Acetabular Cup, as part of routine treatment for total hip replacement procedures. These devices will be implanted by qualified and experienced orthopaedic surgeons as per routine practice. The duration of the procedure will take approximately 1-1.5 hours, as per a standard THA. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed during the pre-operative visit and again at 3 months, 1 year, 2 years, 5 years and 10 years time points post-procedure. Routine x-rays will be analysed at 3 months, 1 year, 2 years, 5 years and 10 years timepoints post-procedure to investigate the radiological performance of the implant in terms of implant placement.
Intervention code [1] 330357 0
Treatment: Devices
Comparator / control treatment
Comparison with commercially available implants will be made based on available data and literature, and will not be collected through directly approaching individuals. The survivorship of the M-Finity stem at 2, 5 and 10 years post-surgery collected from this study will be used to compare against all other commercially available cementless femoral stems used in Australia for primary total hip replacement procedures as reported in the Annual Report of the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data. The federally funded AOANJRR captures nearly all joint replacement procedures in Australia as part of Quality Assurance activities, thereby being the most suitable vehicle to allow for direct comparison of revision rates with all other stems. The results will be compared to participants who underwent primary total hip arthroplasty from the start of data collection in the AOANJRR in September 1999, to the time when data analysis will be conducted for this study. The analysis at the 2, 5 and 10 years is expected to be conducted in 2028, 2031, and 2036 respectively.
Control group
Historical

Outcomes
Primary outcome [1] 340439 0
The primary outcome is to assess the survivorship of the M-Finity femoral stem.
Timepoint [1] 340439 0
1 year, 2 years, 5 years and 10 years post-operative.
Secondary outcome [1] 444058 0
Assess hip function and disability using Patient Reported Outcome Measures. This will be assessed as a composite outcome.
Timepoint [1] 444058 0
baseline (pre-operative) then 3-months, 1-year, 2-years, 5-years, 10-years post-operative.
Secondary outcome [2] 444059 0
Assess patient's awareness of the patient's artificial hip joint during activities of daily living using Patient reported Outcome Measures.
Timepoint [2] 444059 0
3-months, 1-year, 2-years, 5-years, 10-years post-operative.
Secondary outcome [3] 444060 0
Assess disability in patients undergoing total hip arthroplasty by reflecting pain and function using Patient Reported Outcome Measures. This will be assessed as a composite outcome.
Timepoint [3] 444060 0
baseline (pre-operative) then 3-months, 1-year, 2-years, 5-years, 10-years post-operative.
Secondary outcome [4] 444062 0
Leg length discrepancy
Timepoint [4] 444062 0
3-months, 1-year, 2-years, 5-years and 10-years post-operative.
Secondary outcome [5] 444063 0
Global offset reconstruction
Timepoint [5] 444063 0
3-months, 1-year, 2-years, 5-years and 10-years post-operative.
Secondary outcome [6] 444066 0
Stem alignment
Timepoint [6] 444066 0
3-months, 1-year, 2-years, 5-years and 10-years post-operative.
Secondary outcome [7] 444067 0
Acetabular cup position
Timepoint [7] 444067 0
3-months, 1-year, 2-years, 5-years and 10-years post-operative.
Secondary outcome [8] 444068 0
Stem subsidence
Timepoint [8] 444068 0
3-months, 1-year, 2-years, 5-years and 10-years post-operative.

Eligibility
Key inclusion criteria
* Patients undergoing a primary total hip replacement and are suitable for cementless femoral neck preserving stem according to the indications for use (On-Label use).
* BMI less than or equal to 40.
* Skeletally mature adults aged 18 years and over 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
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The subject is classified as morbidly obese (BMI greater than 40)
* Active infection within the affected hip joint.
* Previous total hip replacement or hip fusion of the affected hip joint.
* Intra-articular fracture
* Neuromuscular or neurosensory deficiency which limits the ability to evaluate the safety and effectiveness of the device.
* Diagnosed metabolic disorder which may impair bone formation or bone quality (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy)
* Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
* Workers’ compensation patients or currently in any injury litigation claims

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Kaplan-Meier estimates of survivorship will be used to describe the time to first revision (or time to death) of the M-Finity femoral stem. These estimates are defined as the cumulative percent revision (CPR) at specified years which is the complement (in probability) of the Kaplan-Meier estimates, multiplied by 100. Cumulative percent revision accounts for right censoring due to death and ‘closure’ of the dataset at the time of analysis. Cumulative percent revision is defined as 100 x [1- S(t)] where S(t) is the survivorship probability estimated by the Kaplan-Meier method (see survival curve, below). The cumulative percent revision gives the percent of procedures revised up until time t, and allows for right censoring due to death (but see Cumulative Incidence Function above) or closure of the database for analysis.
The change in patient reported outcomes between pre and post procedure will be analysed using generalised linear mixed models. A normal distribution will be assumed for continuous outcomes (such as Oxford Hip Score).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2025
Actual
Date of last participant enrolment
Anticipated
15/04/2026
Actual
Date of last data collection
Anticipated
15/04/2036
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 318235 0
Commercial sector/Industry
Name [1] 318235 0
Medacta Australia Pty Ltd
Country [1] 318235 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medacta Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320620 0
None
Name [1] 320620 0
None
Address [1] 320620 0
Country [1] 320620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316876 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 316876 0
Ethics committee country [1] 316876 0
Australia
Date submitted for ethics approval [1] 316876 0
05/02/2025
Approval date [1] 316876 0
11/03/2025
Ethics approval number [1] 316876 0

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

Contacts
Principal investigator
Name 139286 0
Dr Lachlan Milne
Address 139286 0
Specialist Orthopaedics, 91 Monash Avenue Nedlands, WA 6009
Country 139286 0
Australia
Phone 139286 0
+61 861508379
Fax 139286 0
Email 139286 0
[email protected]
Contact person for public queries
Name 139287 0
Leina Suzuki
Address 139287 0
Medacta Australia, 16 Mars Road Lane Cove West NSW 2066
Country 139287 0
Australia
Phone 139287 0
+61 1300361790
Fax 139287 0
Email 139287 0
[email protected]
Contact person for scientific queries
Name 139288 0
Leina Suzuki
Address 139288 0
Medacta Australia, 16 Mars Road Lane Cove West NSW 2066
Country 139288 0
Australia
Phone 139288 0
+61 1300361790
Fax 139288 0
Email 139288 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.