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Emphasys Radiostereometric Analysis

NCT06173713 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-10

No results posted yet for this study

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

DEVICE

Emphasys Hip Solutions

Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Canadian Radiostereometric Analysis Network

    lead OTHER

Principal Investigators

  • Thomas Turgeon, MD · Concordia Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173713 on ClinicalTrials.gov