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Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
NCT04325022 · View on ClinicalTrials.gov ↗
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 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04325022
The ClinicalTrials.gov registry entry for NCT04325022 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Smith & Nephew, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04325022 reports 12 study locations spanning 10 distinct geographic areas — top geographies include New York, Other, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04325022?
The interventions under investigation include: Primary Total Hip Arthroplasty (DEVICE), Revision Total Hip Arthroplasty (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04325022?
This trial is sponsored by Smith & Nephew, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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