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Emphasys Radiostereometric Analysis
Sponsor: Canadian Radiostereometric Analysis Network
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.
Official title: Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of Emphasys Hip Solutions
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-02-11
Completion Date
2027-12-31
Last Updated
2025-12-10
Healthy Volunteers
Yes
Conditions
Interventions
Emphasys Hip Solutions
Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem
Locations (1)
Orthopaedic Innovation Centre
Winnipeg, Manitoba, Canada