NCT06172569

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Signature Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hip Replacement

Interventions

Type	Name	Description
DEVICE	Spartan Stem, World Acetabular Cup and World Liner	The Spartan Stem is a wedge-shaped fit and fill design stem with Titanium Plasma Spray(TPS) and Hydroxyapatite (HA) coating. The World Acetabular cup is Porous coated and mated with cross-linked polyethylene World Liner

Timeline

• Start date: 2023-12-08
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-12-15
• Last updated: 2023-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study