Assessing the MonoCer Acetabular Cup in Hip Replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the ten-year clinical outcomes of the MonoCer Acetabular Cup in patients undergoing primary total hip replacement due to end-stage osteoarthritis. Utilizing a multicentre registry-nested approach, the study collects data through the AOANJRR's web-based system to monitor mortality, patient-reported outcomes, and complications. All participants will receive standard care for hip arthroplasty, ensuring that the MonoCer device is used according to its approved labeling without any investigational techniques. The study aims to provide insights into the long-term performance and survivorship of this specific prosthesis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Melbourne Orthopaedic Group
  Melbourne, Australia Recruiting

Study contacts

• Principal investigator: Jit Balakumar — Melbourne Orthopaedic Group
• Study coordinator: Arianna Girardi
• Email: girardi@medacta.ch
• Phone: +41 91 696 60 60

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.