Back to search results

LEGION Medial Stabilized Insert for Total Knee Arthroplasty

This study is looking at the long-term safety and performance of the LEGION Medial Stabilized (MS) Insert when used in total knee replacement surgery (Total Knee Arthroplasty or TKA). Researchers are studying three different combinations of the LEGION MS insert with other knee replacement parts: Cemented CoCr, Cemented Oxinium, and Cementless. You might be able to join if you are between 18 and 80 years old and need a primary TKA due to osteoarthritis, post-traumatic arthritis, or inflammatory arthritis. The main goal is to see how well the implant works for 10 years after surgery. This is an observational study, meaning researchers will watch how the implant performs over time in 144 participants.

Study design
This is an observational study that will follow 144 participants. It is a post-market, prospective and retro-prospective, multicentered study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 years after their operation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07199738

A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)

Recruiting
Not specifiedAges 18–80Observational
Smith & Nephew, Inc.
~144 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Cemented CoCrCemented OxiniumCementless

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Implant Survivorship at 10 Years
Measured over 10 years

Conditions

Inflammatory Arthritis
Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis)
Post-traumatic Arthritis

Explore related trials

ArthritisOsteoarthritisTraumatic Arthritis

Where it's being run

4 sites across 4 states
Massachusetts1
New York1
South Carolina1
Wisconsin1

Study leadership

  • Anasua Ganguly · STUDY_CHAIR · Smith & Nephew, Inc.

Who to contact

Keji Alao
[email protected]
+447816309617
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Pre-operative Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) has been obtained
Post-operative radiographs have been obtained, or these can be collected prospectively in window per schedule of events
12-month post-operative KOOS JR have been obtained, or these can be collected prospectively in window per schedule of events 2. Subject's treating clinician has decided the study device is suitable for the subjects TKA procedure and the study device is used in line with the applicable Instructions For Use (IFU) (listed in section 6). 3. Subject agrees to consent and follow the prospective study visit schedule up to 10 years post-surgery (as defined in the study protocol and informed consent form) by signing the Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved consent form. 4. Subject is able to read, understand and communicate responses to Patient Reported Outcome Measure (PROM). 5. Subject is 18-80 years old at the time of consent (inclusive).

What this trial measures

  • Implant Survivorship at 10 Years10 years

    Implant survivorship at 10 years post-surgery. Implant survivorship is defined as the cumulative proportion of knee-implanted components without a revision. Survivorship is defined as absence of revision of any, or all, of the tibial / femoral / insert components that were implanted during the primary TKA - not including the patella. (Revision is the removal of some, or all, of the above specified implant components, and replacement with new ones for any reason).