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RECRUITING
NCT05785364

A Post Market Surveillance Study About the MONOCER Cup

Sponsor: Medacta International SA

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2022-01-25

Completion Date

2050-02-01

Last Updated

2024-05-01

Healthy Volunteers

No

Interventions

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

Locations (1)

Hirslanden, Clinique la Colline

Geneva, Switzerland