Clinical Trial

Emphasys Radiostereometric Analysis

Recruiting

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2023-12-13; most recent amendment 2025-12-03.

Status change: Not Yet Recruiting → Recruiting 2025-12-03

Trial Details

NCT Number	NCT06173713
Lead Sponsor	Canadian Radiostereometric Analysis Network Collaborators: Johnson & Johnson
Conditions	Hip Osteoarthritis
Enrollment	30 participants
Start Date	2025-02-11
Primary Completion	2027-08-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-10