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Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study

Hip Replacement Clinical Trial

Official title:
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study

Clinical Trial Summary

The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a 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 Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up. The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered. 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. Radiography analysis will be done 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 NCT06172569
Study type Observational
Source Signature Orthopaedics
Contact Satish Shejale, MS Ortho
Phone +61 02 9428 5181
Email satish.shejale@signatureortho.com.au
Status Recruiting
Phase
Start date December 8, 2023
Completion date April 1, 2028
View Details
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