Clinical Trial

A Post Market Surveillance Study About the MONOCER Cup

Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-03-24.
Trial Details
NCT Number NCT05785364
Lead Sponsor Medacta International SA
Conditions Total Hip Arthroplasty
Enrollment 250 participants
Start Date 2022-01-25
Primary Completion 2050-02-01 (estimated)
Study Completion 2050-02-01 (estimated)
Updated on ClinicalTrials.gov 2024-05-01