MDR - M/L Taper With Kinectiv Technology Stems & Necks

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 M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up*. ML Taper with Kinectiv Technology has been on the market since 2008, but has insufficient long term clinical data. Therefore, 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). *Follow-up with the patient at the 10 year time point will be collected by the site prospectively and the 1, 2 and 5 year time point data will be collected by the sponsor retrospectively from an existing database including ML Taper with Kinectiv Technology patients from a Zimmer Biomet hip registry. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04027140
Study type	Observational
Source	Zimmer Biomet
Contact	Abigail Fishel
Phone	5745261765
Email	abigail.fishel@zimmerbiomet.com
Status	Recruiting
Phase
Start date	January 22, 2020
Completion date	September 2024

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See also
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MDR - M/L Taper With Kinectiv Technology Stems and Necks

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms