Knee implants tracked for 10 years after surgery
NCT ID NCT03720782
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 Hide 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.
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.
- Custom knee guides put to the test in obese patients
- Surgeons test augmented reality to Fine-Tune knee replacement cuts
- Can a purified form of ibuprofen better tame osteoarthritis pain?
- Could simple home exercises be the key to better knee health?
- Can a new plastic hip liner outlast the old ones?
- Which injection eases arm pain better: steroid or Anti-Inflammatory?