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Clinical Trial Summary

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.


Clinical Trial Description

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete™ femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty: The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04731077
Study type Interventional
Source Zimmer Biomet
Contact Lisette Smid, PhD
Phone +31 62 395 6378
Email lisette.smid@zimmerbiomet.com
Status Recruiting
Phase N/A
Start date September 27, 2021
Completion date June 1, 2036

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