An observational study in Survival, Prosthesis, sponsored by Medacta International SA. Active, not recruiting at 1 site in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Medacta International SA · Observational
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.
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.
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.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 280 is above the median of 119 across 49 observational studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Medacta International SA is the lead sponsor of 46 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least 280 patients will be recruited who will have the Mpact 3D Metal MonoCer acetabular cup prosthesis from four surgeons in Australia.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 2 years
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.
Time frame: 5 years
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.
Time frame: 10 years
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.
Time frame: pre-op, 6 months, 1 year, 2 years, 5 years, 10 years
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.
Time frame: pre-op,6 months, 1 year, 2 years, 5 years, 10 years
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).
Time frame: pre-op,6 months, 1 year, 2 years, 5 years, 10 years
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.
Time frame: 6 months, 1 year, 2 years, 5 years, 10 years
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.
Time frame: pre-op,6 months, 1 year, 2 years, 5 years, 10 years
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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