NCT05785364

A Post Market Surveillance Study About the MONOCER Cup

Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients candidated to receive a total hip arthroplasty under 75 years old, who will receive a Mpact 3D Metal cup will be proposed to take part to the study. They will receive the same treatment in case they will not partecipate; the study is an observational study according to standard practice. The study aim to assess the long term peformance of the cup at 10 years after surgery. The patients will be visited at 6 months, 1, 5 and 10 years after surgery.

Conditions

• Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2022-01-25
• Primary completion: 2050-02-01
• Completion: 2050-02-01
• First posted: 2023-03-27
• Last updated: 2024-05-01

Locations

1 site across 1 country: Switzerland