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Origin Stem and Logical Cup Post Market Clinical Follow-up

Hip Disease Clinical Trial

Official title:
Origin Stem and Logical Cup Post Market Clinical Follow-up

Clinical Trial Summary

The aim of the study is to monitor the performance of the Signature Orthopaedics Origin Stem and Logical Acetabular Cup as part of post-market vigilance and continuous improvement efforts.

Clinical Trial Description

The objective of this PMCF study is to collect data confirming safety, performance and clinical benefits of the Origin Stem and Logical Cup when used for primary total hip arthroplasty at 2 years follow-up. This prospective follow-up series is necessary to obtain data specific to the Origin Stem and Logical Cup considering their relatively recent launch to the market. The study includes pre-operative, operative, discharge, 1 year post-operative and 2 year post-operative evaluations, where data concerning the performance and safety of the device are gathered. In particular, the revision rate of the components will be monitored as the primary objective, along with pre- and post-operative measurement of the Oxford Hip Score (OHS) patient-reported outcome measure (PROM) to quantify patient satisfaction, and radiographic analysis to monitor bony response to the implant and qualify the effectiveness of the cementless fixation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04123600
Study type Observational
Source Signature Orthopaedics
Contact Melody C Labrune, MS
Phone +61 02 9428 5181
Email melody.labrune@signatureortho.com.au
Status Recruiting
Phase
Start date November 19, 2019
Completion date November 19, 2023
View Details
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