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NCT04325022 · ClinicalTrials.gov registry record
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
A clinical trial of Advanced Degeneration of the Hip Joint and Revision of the Hip Joint, sponsored by Smith & Nephew.
- Active
- Registry status
- 177
- Enrollment target
- 12
- Study locations
NCT04325022: Active study of Advanced Degeneration of the Hip Joint and Revision of the Hip Joint, sponsored by Smith & Nephew.
NCT04325022 is a study of Advanced Degeneration of the Hip Joint and Revision of the Hip Joint that is active but no longer recruiting, run by Smith & Nephew. The registered enrollment target is 177 participants. The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04325022, a study of Advanced Degeneration of the Hip Joint and Revision of the Hip Joint, is active but no longer recruiting, sponsored by Smith & Nephew.
- ACTIVE NOT RECRUITING
- Registry status
- 177 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
Assess survivorship of the OR3O™ Dual Mobility System at 2 years post implantation in Primary THA procedures. Survivorship is defined as no revision of the Acetabular Implant and OR3O™ Liner.
Conditions Studied
Interventions
- DEVICE Primary Total Hip Arthroplasty
- DEVICE Revision Total Hip Arthroplasty
Study Locations (12)
New York
- NYU Langone Health - New York
- Hospital for Special Surgery - New York
Other
- Calvary John James Hospital - Deakin
- Queen Mary Hospital - Hong Kong
Kentucky
- University of Kentucky - Lexington
Nebraska
- University of Nebraska Medical Center - Omaha
North Carolina
- Wake Forest School of Medicine - Winston-Salem
Texas
- St. David's Center for Hip and Knee Replacement - Austin
Queensland
- Mater Health Services - Brisbane
Western Australia
- Royal Perth Hospital - Perth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2020-07-27 |
| Est. Completion | 2035-01-31 |
What the registry record for NCT04325022 still lists
NCT04325022 is an observational study that tracks outcomes without assigning an intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Advanced Degeneration of the Hip Joint appearing as the primary indexed condition, and to 2 interventions - of which Primary Total Hip Arthroplasty is the first listed.
NCT04325022 lists 12 locations in 10 states (New York, Other, Kentucky).
Frequently Asked Questions
What is clinical trial NCT04325022 about?
NCT04325022 is a clinical study titled "Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA". 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.
What is the current status of trial NCT04325022?
This trial is currently active not recruiting. The enrollment target is 177 participants. The study started on 2020-07-27. Estimated completion is 2035-01-31.
What conditions does trial NCT04325022 study?
This clinical trial studies the following conditions: Advanced Degeneration of the Hip Joint, Revision of the Hip Joint.
What interventions are being tested in trial NCT04325022?
The interventions under investigation include: Primary Total Hip Arthroplasty (DEVICE), Revision Total Hip Arthroplasty (DEVICE).
Who is sponsoring clinical trial NCT04325022?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04325022 being conducted?
This trial has 12 study locations across Kentucky, Nebraska, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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