NCT04918680

Prospective Post-market Study Examining the Effectiveness of the EcoFit®

Prospective Post-market Study Examining the Effectiveness of the EcoFit® Total Hip System With Implacross® E Polyethylene

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Implantcast North America, LLC · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the EcoFit Hip with implacross E polyethylene for total hip replacement surgery.

Detailed description

This study will assess the performance and success rate of the EcoFit Total Hip System. Survivorship and clinical outcomes will help determine implant success 36 months as defined by specific scoring systems and compared to other published data.

Conditions

• Degenerative Joint Disease
• Femoral Fracture
• Osteoarthritis, Hip
• Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	EcoFit® Total Hip System with implacross® E Polyethylene	The EcoFit® Total Hip System is a primary hip replacement system indicated for patients who are candidates for a primary cementless hip replacement. implacross® E Polyethylene is one of the components in the EcoFit® system.

Timeline

• Start date: 2021-06-21
• Primary completion: 2026-12-30
• Completion: 2027-03-30
• First posted: 2021-06-09
• Last updated: 2021-06-09

Regulatory

• FDA-regulated device study