Monocer AOANJRR Registry-nested Study (NCT05822505) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Monocer AOANJRR Registry-nested Study
Australia280 participantsStarted 2021-01-30
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
Exclusion Criteria
* Rheumatoid arthritis.
* Patients with a history of active infection.
* Any case not described in the inclusion criteria.
* Revision procedures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Survival rate at 2 years compared to all other acetabular cups utilising AOANJRR data revision rates.
Timeframe: 2 years
2
Survival rate at 5 years compared to all other acetabular cups utilising AOANJRR data revision rates.
Timeframe: 5 years
3
Survival rate at 10 years compared to all other acetabular cups utilising AOANJRR data revision rates.