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Clinical Trial Summary

The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative.


Clinical Trial Description

Primary objective The primary objective of this study is to characterize survivorship of the Echo Bi-Metric Microplasty stem in unilateral or bilateral primary total hip arthroplasty at 5 years postoperative. Secondary Objectives Safety will be evaluated by monitoring the frequency and incidence of adverse events over time to 10 years postoperative. Clinical, functional, radiographic, and quality of life outcomes will be assessed over time to 7 years postoperative. Clinical Outcomes will be measured using the Harris Hip Score and Physical Exam form. Radiographs will be reviewed to assess alignment, radiolucencies and other radiographic parameters. Health status and functional ability will be measured using the EQ-5D-3L and the UCLA Activity score. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04326010
Study type Observational
Source Zimmer Biomet
Contact
Status Active, not recruiting
Phase
Start date February 20, 2017
Completion date February 20, 2030

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