A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Inser… (NCT07199738) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)
United States144 participantsStarted 2025-11
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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).
Exclusion criteria
✕. 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.
✕. 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.