Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Knee implants tracked for 10 years after surgery

NCT ID NCT03720782

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 118 people who already received a LEGION knee implant during total knee replacement surgery. Researchers will check how well the implants hold up over 10 years by measuring implant survival and patient quality of life using questionnaires. The goal is to confirm the long-term safety and performance of these devices.

What this could mean

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

Active substance
LEGION porous HA tibial baseplate and/or CR femoral component (knee implant device)
What this could lead to
If successful, this study could confirm that these knee implants are safe and work well for many years after surgery.
What could go wrong
This is an observational follow-up study, not a test of a new treatment. Results may not apply to all patients, and some implants may fail 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

118 people

The number who actually took part.

Started

May 2019

Expected to finish

Dec 2032

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

Maximum of 150 subjects enrolled to obtain a minimum of 150 implanted components: * Maximum of 75 subjects to obtain a minimum of 75 implanted tibial baseplate components (with or without holes) to attain 30 evaluable baseplates with holes and 30 evaluable baseplates without holes (i.e. a combined total of 60 evaluable implanted baseplate components) * Maximum of 75 subjects to obtain a minimum of 75 implanted LEGION Porous HA CR Femoral Components to attain 60 evaluable components. Note: Some subjects may have received both the LEGION Porous HA Tibial Baseplate (with or without holes) and the LEGION Porous HA CR Femoral Component during their TKA procedure.

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 Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis). 2. Subject received primary TKA between 24 and 60 months prior to the time of consent. Inclusion criteria for prospective follow-up (subjects must meet criteria 1 \& 2 from above and criteria 3,4 and 5 below): 3. Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form. 4. Subject must be available through ten (10) years postoperative follow-up. 5. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English. Exclusion Criteria: Exclusion criteria for retrospective chart review - Any one (1) of the following criteria will disqualify a potential subject from participation in the retrospective chart review: 1. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty 2. Subject has ipsilateral hip arthritis resulting in flexion contracture. 3. At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty. 4. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease). 5. Subject has a known allergy to one or more of its components of the study device. 6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days. Exclusion criteria for prospective follow-up - Any one (1) of the criteria from 1-6 above will disqualify a potential subject from participation in the prospective follow-up) as will any one (1) of the below criteria 7, 8 and 9: 7. 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. 8. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits. 9. Subject is found to have had a revision of the study device(s).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Osteoarthritis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Saint Louis University Hospital, Dept. of Orthopaedic Surgery

    St Louis, Missouri, 63104, United States

  • Twin Cities Orthopedics

    Coon Rapids, Minnesota, 55434, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.