MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup &

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point. The primary objective is to confirm the safety of the implants. This will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Relationship of the events to either implant or instrumentation will be specified. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded Patient Reported Outcomes Measures (PROMs). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05199870
Study type	Observational
Source	Zimmer Biomet
Contact	Richard Marek
Phone	574-453-7567
Email	richard.marek@zimmerbiomet.com
Status	Recruiting
Phase
Start date	December 17, 2021
Completion date	September 3, 2030

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MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms