NCT04277416

Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty

Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty: A Prospective Multi-Centre Cohort Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Ortho Development Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.

Detailed description

The purpose of this study is to provide clinical evidence for the safety and effectiveness of Ortho Development® Corporation's Entrada™ Hip System (Figure 1). The Entrada™ Hip System was fully introduced to the US market in July, 2018. The Entrada™ Hip System includes the Entrada™ Hip Stem, an FDA approved (510(K) # K171249) femoral stem coupled with either a cobalt chrome or Biolox® Delta Ceramic femoral head. Additionally, the stem and head are coupled with either the Escalade® or Legend® acetabular shell, both of which utilize highly cross-linked polyethylene liners.

Conditions

• Total Hip Replacement
• Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	Total Hip Arthroplasty	To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.

Timeline

• Start date: 2020-02-28
• Primary completion: 2031-12-31
• Completion: 2032-12-31
• First posted: 2020-02-20
• Last updated: 2022-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study