Inflammatory ArthritisNCT07199738
A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)
An observational study of Inflammatory Arthritis and Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis), run by Smith & Nephew, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to assess the long-term safety and performance of the LEGION Medial Stabilized insert and to generate clinical evidence to support and maintain product registration in global markets. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Arthritis, Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis), Post-traumatic Arthritis
- What is being tested?
- Cemented CoCr, Cemented Oxinium and Cementless
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Sep 2025to Dec 2036
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants needing primary Total Knee Arthroplasty (TKA) due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis. OR Participants which have undergone primary TKA using the investigational product in the past 12 months to repair degenerative joint disease, post-traumatic arthritis or inflammatory arthritis and all the following conditions have been met: * 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
Who may be able to join
- A). Prospective Subjects: Subject needing primary Total Knee Arthroplasty (TKA) due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
- OR
- B). Retro-prospective Subjects: Subject has undergone primary TKA using the investigational product in the past 12 months to repair degenerative joint disease, post-traumatic arthritis or inflammatory arthritis and all the following conditions have been met:
- 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
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- 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).
- 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.
- Subject is able to read, understand and communicate responses to Patient Reported Outcome Measure (PROM).
- Subject is 18-80 years old at the time of consent (inclusive).
Who cannot join
- Subject received revision TKA on the contralateral knee for a previously failed TKA, or Unicondylar Knee Arthroplasty (UKA).
- Subject has a Body Mass Index (BMI) ≥ 40 at pre-operative visit.
- Subject has ipsilateral hip arthritis resulting in flexion contracture of the hip joint.
- At the time of surgery, subject has one or more of the following arthroplasties that are not fully healed and/or well-functioning, in the opinion of the Investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; contralateral primary TKA or UKA.
- 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).
- Subject has a known allergy to one or more of the components of the study device.
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- Any subject with hardware present in ipsilateral distal femur or proximal tibia.
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
- Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days (30 days from operation/dosing).
- Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, ability to consent or complete the PROMs, including mental illness, drug or alcohol abuse.
- In the opinion of the Investigator, or site staff, Subject is at risk for lost to follow-up, or failure to return for scheduled visits.
- Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures at the time of screening or the time of surgery.
- Subjects who have participated previously in this clinical trial and who have been withdrawn.
- Subject does not meet the indication or is contraindicated for TKA according to specific Smith+Nephew LEGION Knee System IFU.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Erik Hansen, 843-876-0111, Hanseeri@musc.edu
Erik Hansen
- Not yet recruiting
University of Wisconsin
Madison, Wisconsin, 53715-1218
Brian Nickel, 608-265-9132, Nickel@ortho.wisc.edu
Brian Nickel
- Recruiting
New York University Hospital
New York, New York, 10016
Ran Schwarzkopf, 212-513-7711, Ran.Schwarzkopf@nyulangone.org
Ran Schwarzkopf
- Recruiting
Newton Wellesley Hospital
Newton, Massachusetts, 02462
Hayden Box, 617-831-7143, hbox@mgb.org
Hayden Box
About this study
The purpose of this study is to assess the long-term safety and performance of the LEGION Medial Stabilized insert and to generate clinical evidence to support and maintain product registration in global markets.
Read the detailed description
This is a post market, prospective and retro-prospective, multicentered 10-year observational study. The study is looking at the LEGION Medial Stabilized insert used in primary total knee arthroplasty alongside specific tibia and femur component combinations. There will be 144 knees enrolled across 3 cohorts in the study. All enrolled knees will undergo a primary knee arthroplasty due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis. Enrolled subjects will be followed up for 10 years post operation.
- Conditions
- Inflammatory Arthritis, Primary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis), Post-traumatic Arthritis
- Being tested
- Cemented CoCr, Cemented Oxinium, Cementless
- Keywords
- Primary TKA, Osteoarthritis, post-traumatic arthritis, inflammatory arthritis
- Medical subject headings
- Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemented CoCrDevice
Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component
Cemented OxiniumDevice
Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component
CementlessDevice
Primary TKA performed using the LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component
| Study group | Role | What they receive |
|---|---|---|
| Cemented CoCr | LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component Receives: Device: Cemented CoCr | |
| Cemented Oxinium | LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component Receives: Device: Cemented Oxinium | |
| Cementless | LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component Receives: Device: Cementless |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship at 10 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).
Measured: 10 years
Secondary outcomes (6)
Implant Survivorship
Implant survivorship at 6 weeks, 1, 2, 3, 5, 7 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).
Measured: 6 weeks, 1 year, 2 years, 3 years, 5 years, and 7 years
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
The Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) is a validated short form of the KOOS that assesses patient stiffness (1 item), pain (4 items), and functions of daily living (2 items). Scores range from 0 to 100 with a score of 0 indicating total knee disability (i.e., worse outcome) and 100 indicating perfect knee health (i.e., better outcome).
Measured: 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Oxford Knee Score (OKS)
The OKS consists of twelve questions covering function and pain associated with the knee. Scores from the twelve questions are combined to provide an overall score that ranges from 0 to 48, with higher scores indicating better knee function and less pain (i.e., a better outcome)
Measured: 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Forgotten Joint Score (FJS)
The Forgotten Joint Score (FJS) is a patient reported outcome that focuses on the participant's awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. Scores are on a scale of 1 to 100, with higher scores indicating a better outcome.
Measured: 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Five-Level EuroQol Five-Dimensional (EQ-5D-5L): Index Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The descriptive system (i.e., index score) is used to describe the participant's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate their health state by marking the most appropriate statement in each of the five areas. The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health.
Measured: 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Five-Level EuroQol Five-Dimensional (EQ-5D-5L): Visual Analogue Scale Score
The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS records the participant's self-rated health on a vertical visual analogue scale. The scale ranges from 0 to 100 where 0 indicates 'The worst health you can imagine' and 100 indicates 'The best health you can imagine'.
Measured: 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start25 Sep 2025
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anasua Ganguly, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199738
- Sponsor's protocol ID
- SNIS-O-1285
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No