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Knee implant study tracks 10-Year performance

NCT ID NCT03687593

Disease control Sponsor: Smith & Nephew, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well a specific knee replacement implant works over 10 years. Researchers are checking the safety and performance of the Legion knee implant in 126 people who already received it. The goal is to see how long the implant lasts and if it helps patients with knee arthritis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Legion knee replacement implant (made of Oxinium or CoCr metal with a special plastic insert)
What this could lead to
If successful, this could confirm that this knee implant is safe and durable for long-term use, helping people with knee arthritis move better.
What could go wrong
This is an observational study of an already-used device, not a test of a new treatment. Results may not apply to all patients, and some implants may fail or cause complications over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

126 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Investigators will screen all subjects who underwent TKA with the LEGION™ CR Oxinium and CoCR Femoral Implants

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject received primary TKA with the Legion™ CR Femoral Implant (either Oxinium or CoCr) with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, degenerative arthritis, or rheumatoid arthritis). 2. Subject received primary TKA between 24 and 66 months prior to the time of consent. 3. Subject agrees to consent and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form. 4. Subject must be available through ten (10) years postoperative follow-up. Exclusion Criteria: 1. Subject had Body Mass Index (BMI) \> 40 at time of surgery. 2. Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert as a revision surgery. 3. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease). 4. Subject has a known allergy to one or more of its components of the study device. 5. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse. 6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days. 7. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

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Conditions

The condition(s) this trial relates to.

osteoarthritis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Total knee arthroplasty

Contacts and locations

Locations

  • Allina Health Systems

    Edina, Minnesota, 55439, United States

  • Appalachian Orthopedic Associates

    Johnson City, Tennessee, 37604, United States

  • Hawkins Foundation

    Greenville, South Carolina, 29615, United States

  • ROC Foundation

    Reno, Nevada, 89503, United States

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