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Clinical Trial Summary

The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.


Clinical Trial Description

Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study.

The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery.

The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04322916
Study type Observational
Source Mathys Ltd Bettlach
Contact
Status Active, not recruiting
Phase
Start date September 15, 2009
Completion date April 2022

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