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Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA

NCT04325022 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 177

Last updated 2026-05-22

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility System over a ten year period. Survivorship of THA will be assessed up to ten years.

Conditions

  • Advanced Degeneration of the Hip Joint
  • Revision of the Hip Joint

Interventions

DEVICE

Primary Total Hip Arthroplasty

Primary Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components

DEVICE

Revision Total Hip Arthroplasty

Revision Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Ran Schwarzkopf, MD · NYU Langone Health

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2026-02-23
Completion
2035-01-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Hong Kong

Study Locations

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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 NCT04325022 on ClinicalTrials.gov