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Trial registered on ANZCTR


Registration number
ACTRN12625000339459p
Ethics application status
Submitted, not yet approved
Date submitted
1/04/2025
Date registered
22/04/2025
Date last updated
22/04/2025
Date data sharing statement initially provided
22/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Single site, pilot study to evaluate the safety and clinical effectiveness of the M-Finity stem in primary total hip arthroplasty through a CT-based migration analysis.
Scientific title
Evaluating the safety and clinical effectiveness of the M-Finity stem in patients undergoing total hip arthroplasty through a CT-based migration analysis.
Secondary ID [1] 314089 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Arthroplasty 336859 0
Degenerative Joint Disease 336860 0
Congenital or Developmental disorders 336862 0
Condition category
Condition code
Musculoskeletal 333335 333335 0 0
Osteoarthritis
Musculoskeletal 333351 333351 0 0
Other muscular and skeletal disorders
Surgery 333352 333352 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total Hip Arthroplasty (THA) is a procedure commonly performed for end-stage hip osteoarthritis, in which the damaged bone and cartilage of the hip joint are removed and replaced with prosthetic components. The procedure involves accessing the hip joint via an appropriate surgical approach, resecting the femoral head, preparing the acetabulum and femur, and implanting the acetabular cup and femoral stem. The femoral head is then attached to the stem, and the hip is reduced to assess joint stability and leg length. Patients meeting the eligibility criteria for THA will be considered for enrolment in this study. The total surgical procedure typically takes approximately 1 to 2 hours, depending on patient anatomy and surgical approach. The implantation of the femoral stem component specifically takes approximately 20–30 minutes within this timeframe.

The M-Finity femoral stem, designed for THA, aims to provide optimal fit and stability. Each participant will receive the Medacta M-Finity femoral stem along with a compatible Medacta Acetabular Cup as part of routine total hip replacement. These devices will be implanted by an experienced orthopaedic surgeon following standard practice. The study aims to evaluate the safety and clinical effectiveness of the M-Finity femoral stem, which features a triple-tapered design with reduced distal width to enhance proximal fit and minimize distal impingement.

Operative reports and intraoperative checklists will be reviewed to confirm that the M-Finity femoral stem was used as intended. Implant labels will be verified to ensure traceability and correct device allocation. Any deviations from the standard procedure will be documented and reviewed by the study team.
Intervention code [1] 330664 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340909 0
The primary outcome is to evaluate the clinical effectiveness of the M-Finity stem in primary total hip arthroplasty.
Timepoint [1] 340909 0
Computed tomography migration analysis of stem migration and rotation will be assessed at Baseline (day 0 to day 1 - post operative), and at post operative time points 3-months and 1-year.
Primary outcome [2] 340910 0
Device Related Adverse Events
Timepoint [2] 340910 0
Adverse events will be monitored for the entirety of the study, which is foreseen to be 2 years post implant. This includes safety analysis intra-operatively and then immediately post surgery, at 3-Months, 1 year and 2 years post surgery.
Secondary outcome [1] 445425 0
Assess hip function and disability using Patient Reported Outcome Measures. This will be assessed as a composite outcome.
Timepoint [1] 445425 0
Baseline (pre-operative) then 3-months, 1-year, and 2-years post-operative.
Secondary outcome [2] 445520 0
Assess patient's awareness of the patient's artificial hip joint during activities of daily living using Patient reported Outcome Measures.
Timepoint [2] 445520 0
baseline (pre-operative) then 3-months, 1-year, and 2-years, post-operative.
Secondary outcome [3] 445521 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] 445521 0
Baseline (pre-operative) then 3-months, 1-year, and 2-years, Post-operative.

Eligibility
Key inclusion criteria
1. 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).
2. BMI less than or equal to 40.
3. Skeletally mature adults aged 18 years and over at the time of registration.
4. Ability to give informed consent.
5. 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
1. Not meeting the inclusion criteria.
2. The subject is classified as morbidly obese (BMI>40)
3. Active infection within the affected hip joint.
4. Previous total hip replacement or hip fusion of the affected hip joint.
5. Intra-articular fracture
6. Neuromuscular or neurosensory deficiency which limits the ability to evaluate the safety and effectiveness of the device.
7. Diagnosed metabolic disorder which may impair bone formation or bone quality (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy)
8. Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
9. Workers’ compensation patients or currently in any injury litigation claims
10. Women of childbearing potential

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27681 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 43858 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318596 0
Commercial sector/Industry
Name [1] 318596 0
Medacta Australia Pty Ltd
Country [1] 318596 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medacta Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321107 0
None
Name [1] 321107 0
None
Address [1] 321107 0
Country [1] 321107 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317197 0
Ramsay Health Care WA / SA Human Research Ethics Committee
Ethics committee address [1] 317197 0
Ethics committee country [1] 317197 0
Australia
Date submitted for ethics approval [1] 317197 0
18/03/2025
Approval date [1] 317197 0
Ethics approval number [1] 317197 0

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

Contacts
Principal investigator
Name 140314 0
Dr Lachlan Milne
Address 140314 0
Specialist Orthopaedics, 91 Monash Avenue Nedlands, WA 6009
Country 140314 0
Australia
Phone 140314 0
+61 86150 8379
Fax 140314 0
Email 140314 0
[email protected]
Contact person for public queries
Name 140315 0
Leina Suzuki
Address 140315 0
Medacta Australia, 16 Mars Road Lane Cove West NSW 2066
Country 140315 0
Australia
Phone 140315 0
+61 1300361790
Fax 140315 0
Email 140315 0
[email protected]
Contact person for scientific queries
Name 140316 0
Leina Suzuki
Address 140316 0
Medacta Australia, 16 Mars Road Lane Cove West NSW 2066
Country 140316 0
Australia
Phone 140316 0
+61 1300361790
Fax 140316 0
Email 140316 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.