MDR - PMCF Study for Taperloc Complete Stems

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, 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 safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs). *The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04028687
Study type	Observational
Source	Zimmer Biomet
Contact	Abigail Fishel
Phone	574-526-1765
Email	Abigail.Fishel@zimmerbiomet.com
Status	Recruiting
Phase
Start date	February 13, 2020
Completion date	February 12, 2032

View Details

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