Avenir Complete Post-Market Clinical Follow-Up Study

Status Recruiting

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

Clinical Trial Details

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

View Details

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