RecruitingInflammatory ArthritisPrimary Total Knee Arthroplasty Due to Degenerative Joint Disease (Primary Diagnosis of Osteoarthritis)Post-traumatic Arthritis
A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)
Eligible age
18–80 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
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.
Sponsor: Smith & Nephew, Inc.
You may qualify if…
- ✓ 1. 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
- ✓ 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.
You may not qualify if…
- ✕ 1. Subject received revision TKA on the contralateral knee for a previously failed TKA, or Unicondylar Knee Arthroplasty (UKA).
- ✕ 2. Subject has a Body Mass Index (BMI) ≥ 40 at pre-operative visit.
- ✕ 3. Subject has ipsilateral hip arthritis resulting in flexion contracture of the hip joint.
- ✕ 4. 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.
- ✕ 5. 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).
- ✕ 6. Subject has a known allergy to one or more of the components of the study device.
- ✕ 7. Any subject with hardware present in ipsilateral distal femur or proximal tibia.
- ✕ 8. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07199738 · last updated 2026-08-06