Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000586617
Ethics application status
Approved
Date submitted
17/05/2023
Date registered
30/05/2023
Date last updated
30/05/2023
Date data sharing statement initially provided
30/05/2023
Date results information initially provided
30/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Investigation into the Clinical Performance of the Medacta Masterloc Stem in patients undergoing Total Hip Replacement Procedures
Scientific title
An Investigation into the Clinical Performance of the Medacta Masterloc Stem in patients undergoing Total Hip Replacement Procedures
Secondary ID [1] 303970 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 321586 0
total hip arthroplasty 330026 0
Condition category
Condition code
Musculoskeletal 319327 319327 0 0
Osteoarthritis
Surgery 327006 327006 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. During THA, the damaged bone and cartilage is removed and replaced with several prosthetic components, including a femoral stem and acetabular cup.

The MasterLoc HA femoral stem is a cementless flat dual tapered wedge stem, designed to restore the anatomy of the patient enhancing mediolateral stability with reduced removal of bone. This uniquely designed stem offers three offset options within an 11 mm range that do not change leg length. Furthermore, it is coated with a proprietary technology, called Mectagrip, with plasma sprayed titanium and hydroxyapatite to assist with biological fixation.

The newly designed MasterLoc Stem device has been introduced into the Australian market, however, its short and long-term performance is yet to be evaluated. The purpose of this current investigation will be to observe the level of patient satisfaction reported following implantation of a MasterLoc stem.

Patients who are planned to undergo THA surgery and fit the eligibility criteria will be considered for enrolment in this study. The stem 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. Adherence to the intervention will be monitored through radiological examination for stem loosening using the routine radiographs taken at post-operative visitation as part of the surgeon's standard of care.
Intervention code [1] 320282 0
Treatment: Devices
Comparator / control treatment
There is no comparator arm
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334760 0
Mean scores on patient reported outcome questionnaire - Hip Disability and Osteoarthritis Outcome Score (HOOS) questionnaire to assess patient's opinion about their hip and associated problems
Timepoint [1] 334760 0
preoperative, 1 year, 2-year postoperative (primary timepoint)
Primary outcome [2] 334761 0
Mean scores on patient reported outcome questionnaire - Artificial prosthesis awareness assessed using the Forgotten Joint Score (FJS)
Timepoint [2] 334761 0
1 year, 2-year postoperative (primary timepoint)
Primary outcome [3] 334864 0
Mean scores on patient reported outcome questionnaire - Quality of life assessed using the EQ-5D-5 questionnaire
Timepoint [3] 334864 0
preoperative, 1 year, 2-year postoperative (primary timepoint)
Secondary outcome [1] 422086 0
Mean scores on patient reported outcome questionnaire - Visual Analogue Scale (VAS) Satisfaction
Timepoint [1] 422086 0
1 year, 2-year postoperative
Secondary outcome [2] 422285 0
Mean scores on patient reported outcome questionnaire - Visual Analogue Scale (VAS) Pain to assess level of pain associated with the hip
(This is an additional primary outcome)
Timepoint [2] 422285 0
preoperative, 1 year, 2-year postoperative (primary timepoint)

Eligibility
Key inclusion criteria
Patients with symptomatic arthritis who are candidates for a primary total hip replacement with an uncemented femoral stem as determined jointly by the surgeon and the patient.
Patients able to give informed consent
Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had a previous total hip replacement or hip fusion of the affected hip
Pregnant women or those seeking to become pregnant
Patients with a history of active infection
Patients who are a prisoner, currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, or known alcohol or substance abuse
Patients who are immunologically suppressed

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
Efficacy
Statistical methods / analysis
The mean, median, standard deviation, minimum and maximum will be presented for the study group for quantitative variables and the appropriate parametric or non-parametric statistical test will be used, depending on the distribution of the data. Changes over time are assessed with the ANOVA, in case of non-normal distribution of data, non-parametric statistics test will be performed. For all analyses, significance is set to a p-value = 0.05

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/03/2021
Date of last participant enrolment
Anticipated
Actual
18/08/2022
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
250
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 308352 0
Commercial sector/Industry
Name [1] 308352 0
Medacta Australia Pty Ltd
Country [1] 308352 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] 315701 0
None
Name [1] 315701 0
Address [1] 315701 0
Country [1] 315701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308324 0
Ramsay Health Care NSW/VIC Human Research Ethics Committee
Ethics committee address [1] 308324 0
Level 8, 154 Pacific Highway
ST LEONARDS NSW 2065
Ethics committee country [1] 308324 0
Australia
Date submitted for ethics approval [1] 308324 0
13/04/2020
Approval date [1] 308324 0
21/12/2020
Ethics approval number [1] 308324 0

Summary
Brief summary
In a total hip replacement (THR), also called total hip arthroplasty, the damaged bone and cartilage is removed and replaced with prosthetic components.
Secondary stability of the femoral stem is a prerequisite to secondary bone ingrowth and proper long-term fixation. Initial or primary stability of uncemented stems depends either on filling the proximal femur with intimate contact between the stem and the anatomic shape of the proximal femur (an anatomic fit) or filling the femoral diaphysis.

The MasterLoc HA femoral stem is a cementless flat dual tapered wedge stem, designed to restore the anatomy of the patient enhancing mediolateral stability with reduced removal of bone. The stem features a shortened stem length and reduced distal geometry. It is coated, using a proprietary technology, called Mectagrip, with plasma sprayed titanium and hydroxyapatite to to assist with biological fixation.

The aim of this study is to assess patient satisfaction and clinical outcomes following placement of a MasterLoc Stem for Total Hip Arthroplasty.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110306 0
Dr Michael Dixon
Address 110306 0
Kareena Private Hospital, 86 Kareena Road, Caringbah, NSW, 2229
Country 110306 0
Australia
Phone 110306 0
+61 2 9525 2055
Fax 110306 0
Email 110306 0
[email protected]
Contact person for public queries
Name 110307 0
Dr Selin Kulaga
Address 110307 0
Medacta Australia Pty Ltd
Unit A1, 16 Mars Road
Lane Cove, NSW 2066
Country 110307 0
Australia
Phone 110307 0
+61 1300 361 790
Fax 110307 0
Email 110307 0
[email protected]
Contact person for scientific queries
Name 110308 0
Dr Selin Kulaga
Address 110308 0
Medacta Australia Pty Ltd
Unit A1, 16 Mars Road
Lane Cove, NSW 2066
Country 110308 0
Australia
Phone 110308 0
+61 1300 361 790
Fax 110308 0
Email 110308 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?

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.