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Survival, ProsthesisNCT05822505

Monocer AOANJRR Registry-nested Study

An observational study of Survival, Prosthesis, run by Medacta International SA at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data collection system integrated with Registry data collection, designed to assess the ten-year… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Survival, Prosthesis
How many people
280 participants
Where
1 siteAustralia
Study dates
30 Jan 2021to Jun 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

Study population: At least 280 patients will be recruited who will have the Mpact 3D Metal MonoCer acetabular cup prosthesis from four surgeons in Australia.

Who may be able to join

  • Patients undergoing a primary total conventional hip replacement and are suitable for cementless acetabular cup according to the indications for use (On-label use).
  • Use of the 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.

Who cannot join

  • Rheumatoid arthritis.
  • Patients with a history of active infection.
  • Any case not described in the inclusion criteria.
  • Revision procedures.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Melbourne Orthopaedic Group

    Melbourne

Other trials in Australia

About this study

Official title: Prospective, Multicentre Study to Assess Performance of the Mpact 3D Metal MonoCer Cup Implant in Primary Total Hip Replacement

This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data collection system integrated with Registry data collection, designed to assess the ten-year clinical outcome of the MonoCer Acetabular Cup in Primary Total Hip Replacement. The primary outcome measure is mortality and secondary measures are PROMs and complications.

Read the detailed description

This study titled "Prospective, Multicentre Study to Assess Performance of the MonoCer Acetabular Cup in Primary Total Hip Replacement" is a multi-centre prospective registry-nested cohort study, using AOANJRR's web-based data collection system integrated with Registry data collection, designed to assess the ten-year clinical outcome of the MonoCer Acetabular Cup in Primary Total Hip Replacement. The primary outcome measure is mortality and secondary measures are PROMs and complications.

The purpose and objectives of this study are to assess and document the clinical outcomes in a group of primary total hip arthroplasty patients having this surgery for the management of end-stage osteoarthritis. Survivorship and changes in pain and function as well as death will be assessed. The design of this study will also allow, if required the continued follow-up after the initial 2 years to determine mid and long-term survivorship and performance of this cohort.

All patients will receive primary hip arthroplasty standard of care (pre and post operatively) as defined by each participating surgeon. In addition to the Medacta MonoCer Acetabular Cup. There shall be no investigational, experimental or "off-label" use of the device. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labelling.

A prospective study will be conducted using the AOANJRR web-based data collection system (RAPID). Eligible and consented participants are registered in the RAPID system. The PROMs will be completed by patients via the RAPID system.

  • Surgeons will determine patient eligibility, providing informed consent prior to enrolment and registration in RAPID.

Participating sites will send procedure data to the AOANJRR as per standard practice, this data is then linked to the study participant. All data will be stored in a secure data repository.

  • A minimum of 280 patients will be recruited over an 18-month period.
  • All data will be integrated with routinely collected Registry data.
Medical subject headings
Prosthesis Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.

    Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.

    Measured: 2 years

  2. Survival rate at 5 years compared to all other acetabular cups utilising AOANJRR data revision rates.

    Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates Analysis of reasons for revisions.

    Measured: 5 years

  3. Survival rate at 10 years compared to all other acetabular cups utilising AOANJRR data revision rates.

    Evaluation of MonoCer acetabular cup revision rates in comparison to all other TGA approved acetabular cup revision rates.

    Analysis of reasons for revisions.

    Measured: 10 years

Secondary outcomes (5)

  1. Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with EQ-5D-5L

    Assessments / Questionnaires (Patient Reported Outcome Measures) EQ-5D-5L (EuroQol) min=0 (worst score) max=100 (best score) The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Measured: pre-op, 6 months, 1 year, 2 years, 5 years, 10 years

  2. Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with OHS

    Assessments / Questionnaires (Patient Reported Outcome Measures) OHS

    The OHS is a short 12-item survey that can be done with pen and paper, or online.

    Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.

    Measured: pre-op,6 months, 1 year, 2 years, 5 years, 10 years

  3. Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with HOOS

    Assessments / Questionnaires (Patient Reported Outcome Measures):

    HOOS

    HOOS: The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process. The HOOS questionnaire is a patient-administered self-report questionnaire and takes 7 to 10 minutes to complete. It is designed to be self-explanatory and user-friendly[1]. The HOOS includes 40 items with five possible responses, graded from 0 to 4 (0 points = worst possible score; 100 points = best possible score).

    Measured: pre-op,6 months, 1 year, 2 years, 5 years, 10 years

  4. Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with MONA

    Assessments / Questionnaires (Patient Reported Outcome Measures):

    MONA (Melbourne Orthopaedic Noise assesment)

    MONA questionnaire, which has a high sensitivity for the detection of noises, concerning noise frequency and the quality of noise. Patients were asked if any noise had been heard from their hip joint at any time after surgery.

    Measured: 6 months, 1 year, 2 years, 5 years, 10 years

  5. Collecting, assessing and documenting patient reported hip function, pain, pre-operative expectations and post-operative satisfaction with VAS

    Assessments / Questionnaires (Patient Reported Outcome Measures):

    VAS (Visual Analog Scale) from 0 (worst) to 100 (best) score.

    The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between paints with similar conditions.

    Measured: pre-op,6 months, 1 year, 2 years, 5 years, 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start30 Jan 2021
  3. Primary completionJan 2031 (estimated)
  4. Study completionJun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822505
Sponsor's protocol ID
P01.026.001
Status last verified
Jun 2025
First submitted
6 Apr 2023
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Survival, Prosthesis, run by Medacta International SA at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates. (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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