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Trial registered on ANZCTR


Registration number
ACTRN12620001098921p
Ethics application status
Not yet submitted
Date submitted
16/09/2020
Date registered
21/10/2020
Date last updated
21/10/2020
Date data sharing statement initially provided
21/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective, Multicentre Study to Assess Performance of a Monoblock Ceramic Cup Implant in Primary Total Hip Replacement
Scientific title
Prospective, Multi-centre Study to Assess Efficacy (Survivorship) of the Mpact 3D Metal MonoCer Cup Implant in Primary Total Hip Replacement
Secondary ID [1] 302315 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis 319076 0
Condition category
Condition code
Musculoskeletal 317026 317026 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
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 enrollment in this study. Each participant will receive the new Medacta Mpact 3D Metal MonoCer acetabular cup device together with a compatible Medacta Femoral Head and Femoral Stem prostheses, 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 and all observational participant data will be collected into the AOANJRR registry as per standard protocols. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed by the AOANJRR during the pre-operative visit and again at 6 month, 1 year, 2 years, 5 years and 10 years time points post-procedure. Each patient will receive SMS/email reminders at each time to log into an online portal and complete each of the questionnaires, at the participant's home using an electronic device of their choice.
Intervention code [1] 318604 0
Not applicable
Comparator / control treatment
Based on National AOANJRR Data Revision notes, the survivorship of the Mpact 3D Metal MonoCer acetabular cup at 2, 5 and 10 years post-surgery will be compared to the performance of all other commercially available acetabular cups used in Australia for primary total hip replacement procedures. 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. Comparison of the Mpact 3D Metal MonoCer device will be made to the performance of all other acetabular cups during the time of which the trial is being conducted (i.e from date of first patient enrollment to date of last patient follow-up time point). Mean differences in patient reported outcomes measure (PROM) scores (EQ-5D-5L, oxford hip score, hip dysfunction, VAS, hip noise assessment and osteoarthritis score) will be obtained pre-surgery and again at 6 months, 1 year, 2 year , 5 years and 10 years post procedure to evaluate the extent of improvement/reduction in patient quality of life, level of pain, satisfaction and rate of complications, compared to scores obtained prior to surgery. There is no plan for these mean PROMS scores to be compared/analysed with other commercially available competitor devices.
Control group
Active

Outcomes
Primary outcome [1] 325130 0
To determine Mpact 3D Metal MonoCer survivorship (efficacy) at 2, 5 and 10 years post-operatively compared to all other cementless acetabular cups. Survivorship will be assessed by determining the time to first revision surgery required following implantation of the Mpact 3D Metal MonoCer acetabular cup device. If time to first revision rates are comparable to other commercially available cups, this is indicative that Mpact 3D Metal MonoCer cup is efficacious. These estimates will be calculated using Kaplan-Meier estimates of survivorship,
Timepoint [1] 325130 0
2-years (primary time-point), 5 and 10 years post-operatively
Secondary outcome [1] 386948 0
Mean scores on patient reported outcome questionnaire EQ-5D-5L. This questionnaire is
a standardised measure of patient health status and quality of life.
Timepoint [1] 386948 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [2] 386949 0
Mean scores on patient reported outcome questionnaire Oxford Hip Score (OHS)
Timepoint [2] 386949 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [3] 386950 0
Mean scores on patient reported outcome questionnaire Hip Dysfunction and Osteoarthritis Score (HOOS)
Timepoint [3] 386950 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [4] 386951 0
Mean scores on patient reported outcome questionnaire Visual Analogue Score (VAS) for Pain
Timepoint [4] 386951 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [5] 386952 0
Number of complications following surgery, including
- Infection rates, aseptic loosening and other causes. These parameters will be documented Registry Data and also from responses to patient questions and phone follow-up (if required)
- Death. This will be determined by linkage to the National Death Index (NDI)
-Medications, hospital admissions and other surgery. These parameters will be determined through linkage with Government data.
Timepoint [5] 386952 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [6] 386953 0
Mean scores on patient reported outcome questionnaire Melbourne Orthopaedic Noise Assessment (MONA) for hip noise
Timepoint [6] 386953 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery

Eligibility
Key inclusion criteria
- Patients undergoing a primary total conventional hip replacement and are suitable for a cementless acetabular cup according to the indications for use (On-label use).
- Use of the non TGA approved (pre-market) Medacta Mpact 3D Metal MonoCer acetabular cup prosthesis.
- 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Rheumatoid arthritis.
- Patients with a history of active infection.
- Any case not described in the inclusion criteria.
- Revision procedures.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Kaplan-Meier estimates of survivorship will be used to describe the time to first revision (or time to death) of the Mpact 3D Metal MonoCer prosthesis (used in combination with compatible Medacta Femoral Stem and Head components). 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. Hazard ratios will be determined using Cox proportional hazards models to compare the rate of revision between the Mpact 3D Metal MonoCer acetabular cup vs all other cementless cups. If the hazard ratio is not proportional, them a time varying model will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 17536 0
The Avenue Private Hospital - Windsor
Recruitment hospital [2] 17537 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 31269 0
3181 - Windsor
Recruitment postcode(s) [2] 31270 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 306740 0
Commercial sector/Industry
Name [1] 306740 0
Medacta Australia Pty Ltd
Address [1] 306740 0
Unit A1, 16 Mars Road, Lane Cove, NSW 2066
Country [1] 306740 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] 307582 0
None
Name [1] 307582 0
Address [1] 307582 0
Country [1] 307582 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 306912 0
Ramsay Health Care Human Research Ethics Committee
Ethics committee address [1] 306912 0
Ramsay Hospitals Research Foundation
2 Frederick St,
St Leonards NSW 2065
Ethics committee country [1] 306912 0
Australia
Date submitted for ethics approval [1] 306912 0
22/10/2020
Approval date [1] 306912 0
Ethics approval number [1] 306912 0

Summary
Brief summary
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, increased wear, dislocation and reduced functional movement, which lead to poorer patient outcomes. Medacta have recently developed a new acetabular cup device called the Mpact 3D Metal Monocer, designed for use in Total Hip Replacement (THA), the acetabular cup is one component of a THA.

The Mpact 3D Metal Monocer device is a cementless hemispherical acetabular shell that comes pre-assembled with a ceramic bearing surface. Pre-assembly may show to have several advantages compared with traditional modular cups used for total hip replacement procedures, including allowing the use of a larger femoral head diameter which can reduce the risk of hip replacement dislocation and reduced wear rates. The Monocer cup is also manufactured with a 3D-Printed titanium alloy material on the back-side to enhance osseointegration and thereby improve implant stability in the bone.

The newly designed Mpact 3D Metal Monocer cup device has recently obtained European CE Mark approval. CE Marking allows the Medacta to supply the Mpact 3D Metal MonoCer device in the European Union (EU). The Medacta Mpact 3D Metal MonoCer acetabular cup is not yet approved by the TGA. Thus, the purpose of this study is to investigate the Monocer cup efficacy (survival) at 2, 5 and 10 years post-surgery and ensure that it performs just as well as other commercially available acetabular cups. The hypothesis for this investigation is that the 2, 5 and 10 year percent revision rate (need to re-implant) is not inferior (comparable) to the average performance of all other cementless cups currently in use in the Australian Market.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105422 0
Dr Jitendra Balakumar
Address 105422 0
Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
Country 105422 0
Australia
Phone 105422 0
+61 3 9573 9659
Fax 105422 0
Email 105422 0
jit.balakumar@me.com
Contact person for public queries
Name 105423 0
Ms Tamara Hooper
Address 105423 0
Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR)
SAHMRI
North Terrace
Adelaide SA 5000
Country 105423 0
Australia
Phone 105423 0
+61 8 8128 4322
Fax 105423 0
Email 105423 0
thooper@aoanjrr.org.au
Contact person for scientific queries
Name 105424 0
Dr Victoria Dokic
Address 105424 0
Medacta Australia
Unit A1, 16 Mars Road
Lane Cove, NSW 2066
Country 105424 0
Australia
Phone 105424 0
+61 1300 631 790
Fax 105424 0
Email 105424 0
victoria.dokic@medacta.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain patient confidentiality and comply with international privacy laws, individual participant data will not be available for this trial.
What supporting documents are/will be available?
No other documents available
Summary results
No Results