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ACTIVE NOT RECRUITING

LEGION Hinge Safety and Efficacy Study

NCT02445443 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).

Conditions Studied

Interventions

  • DEVICE LEGION Hinge Knee System

Study Locations (7)

Iowa

  • University of Iowa Hospitals — Iowa City

New York

  • NYU Hospital for Joint Diseases — New York

Oregon

  • Oregon Health and Science University — Portland

Western Australia

  • Fremantle Hospital — Fremantle

Other

  • UZ Leuven campus Pellenberg — Pellenberg

Manitoba

  • Concordia Hip and Knee Institute — Winnipeg

Barcelona

  • University Hospital Mutua de Terrassa — Terrassa

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2015-06-30
Est. Completion 2028-08-01

Sponsor

Smith & Nephew

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02445443

The ClinicalTrials.gov registry entry for NCT02445443 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 47 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 1 condition, with Knee Arthroplasty, Total appearing as the primary indexed condition, and to 1 intervention — of which LEGION Hinge Knee System 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: NCT02445443 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Iowa, New York, Oregon. 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 NCT02445443 about?

NCT02445443 is a clinical study titled "LEGION Hinge Safety and Efficacy Study". The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly ...

What is the current status of trial NCT02445443?

This trial is currently active not recruiting. The enrollment target is 47 participants. The study started on 2015-06-30. Estimated completion is 2028-08-01.

What conditions does trial NCT02445443 study?

This clinical trial studies the following conditions: Knee Arthroplasty, Total. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02445443?

The interventions under investigation include: LEGION Hinge Knee System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02445443?

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 NCT02445443 being conducted?

This trial has 7 study locations across Iowa, New York, Oregon, Western Australia, Manitoba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial