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Clinical Trial Summary

This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.


Clinical Trial Description

The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM. 500 patients was the enrollment goal with 2 subgroups. - Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements; - Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03357445
Study type Interventional
Source Zimmer Biomet
Contact
Status Active, not recruiting
Phase N/A
Start date October 14, 2011
Completion date April 27, 2027

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