Monocer AOANJRR Registry-nested Study

Launched by MEDACTA INTERNATIONAL SA · Apr 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a specific type of hip replacement device called the MonoCer Acetabular Cup in patients who need a total hip replacement surgery. The goal is to see how well this device works over a ten-year period, focusing on important outcomes like survival rates and any complications that may arise after surgery. The study is currently recruiting participants between the ages of 18 and 75 who are having their first hip replacement and are suitable for this type of implant.

To be eligible, you should be an adult planning to undergo a conventional hip replacement and willing to use the MonoCer Acetabular Cup. You also need to be able to give your consent and participate in follow-up appointments for the study duration. However, if you have rheumatoid arthritis, a history of infections, or if you’re having a revision surgery (a surgery to fix or replace a previous implant), you will not be able to participate. If you join the study, you will help researchers gather important information that could improve hip replacement outcomes for future patients.

Gender

ALL

Eligibility criteria

• 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.