NCT06153940

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

• 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 Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts.

Detailed description

The Objective of this Post market Clinical Follow up (PMCF) study is to collect data confirming safety, performance and clinical benefits of the Everglade Stem, World Acetabular Cup and World Liner when used for a primary total hip arthroplasty at 2 years follow-up. This prospective follow-up series is necessary to gather data for the Everglade Stem, World Acetabular Cup and World Liner as they are recently launched to the market. The data concerning the performance and safety of the devices are gathered in various time frames starting with pre-operative status and then includes operative, at discharge, i year post-operative and 2 year post-operative evaluations. 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 the bony response to the implants and quantify the effectiveness of the cementless fixation.

Conditions

• Hip Disease

Interventions

Type	Name	Description
DEVICE	Treatment	The Everglade™ Stem, is a second generation cementless blade style hip stem Forged in Titanium and proximally Antero-Posterior (AP) flared with Titanium Plasma Spray + Hydroxyapatite (TPS + HA) coated for bone on-growth. The stem has distal geometry and a polished anodized surface finish to minimize the stem hanging in Dorr A femurs. The World Acetabular Cup is a porous coated and mated with the Cross-linked polyethylene World Liner

Timeline

• Start date: 2023-11-22
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study