Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Switzerland / NCT05785364
Recruiting Observational

A Post Market Surveillance Study About the MONOCER Cup

NCT05785364 · tracked via the Priya Life Science Switzerland tracker
Sponsor
Medacta International SA
Phase
Observational
Started
2022-01-25
Last updated
2024-05-01

Condition(s) studied

Total Hip Arthroplasty

Investigational drug(s) / intervention(s)

Mpact 3D metal MONOCER cup

Mpact 3D metal MONOCER cup: adult patients requiring a total hip arthroplasty under 75 years old, will receive the Mpact 3D metal cup, as acetabular sheel device implanted

Study summary

Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use 2. Patients who have signed the informed consent to participate in the study Exclusion Criteria: 1. Minor patients, patients over 75 years of age at the time of primary surgery; 2. Any patient who is unable or unwilling to give informed consent to participate in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hirslanden, Clinique la Colline Geneva Switzerland Recruiting

More Medacta International SA trials in Switzerland

AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study Active, not recruiting
The Medacta GMK SpheriKA Post-Marketing Surveillance Study Recruiting
Clinical and Radiological Outcomes of Medacta Shoulder System Active, not recruiting
The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study Active, not recruiting
GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05785364 on ClinicalTrials.gov ↗ ← All trials in Switzerland