NCT04325022

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

Prospective, Multi-center Study to Evaluate the Safety and Effectiveness of the OR3O™ Dual Mobility System in Primary and Revision Total Hip Arthroplasty (THA) Procedures

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 177 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-07-27
• Primary completion: 2026-12-31
• Completion: 2035-01-31
• First posted: 2020-03-27
• Last updated: 2025-10-27

Locations

12 sites across 4 countries: United States, Australia, Canada, Hong Kong

Regulatory

• FDA-regulated device study