NCT06173713

Emphasys Radiostereometric Analysis

Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of Emphasys Hip Solutions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Canadian Radiostereometric Analysis Network · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study is designed as a prospective, multi-centre, non-randomized, non-controlled study. This study does not limit the procedures involved in the treatment of the subject as long as the protocol specified products are utilized. The primary objective is to establish the mean superior cup migration of the Emphasys Shell and the mean inferior stem migration of the Emphasys Stem using model-based RSA over the first two years post-implantation. Additionally, the data from this study will be compared to historical Pinnacle Acetabular Shell data obtained in study DSJ\_2018\_02.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Emphasys Hip Solutions	Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem

Timeline

• Start date: 2025-02-11
• Primary completion: 2027-08-31
• Completion: 2027-12-31
• First posted: 2023-12-18
• Last updated: 2025-12-10

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study