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ACTIVE NOT RECRUITING
NCT04325022

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

Sponsor: Smith & Nephew, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

177

Start Date

2020-07-27

Completion Date

2035-01-31

Last Updated

2025-10-27

Healthy Volunteers

No

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

Locations (12)

University of Kentucky

Lexington, Kentucky, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

NYU Langone Health

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

St. David's Center for Hip and Knee Replacement

Austin, Texas, United States

Mater Health Services

Brisbane, Queensland, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Calvary John James Hospital

Deakin, Australia

South Health Campus, Calgary

Calgary, Alberta, Canada

St Michael's Hospital

Toronto, Ontario, Canada

Queen Mary Hospital

Hong Kong, Hong Kong