A Multi-Center Study Assessing the Safety and Efficacy of the LEGION Medial Stabilized (MS) Insert in Patients Undergoing a Total Knee Arthroplasty (TKA)
NCT ID: NCT07199738
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
144 participants
OBSERVATIONAL
2025-11-30
2036-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Cemented CoCr
LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component
Cemented CoCr
Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component
Cemented Oxinium
LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component
Cemented Oxinium
Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component
Cementless
LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component
Cementless
Primary TKA performed using the LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component
Interventions
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Cemented CoCr
Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component
Cemented Oxinium
Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component
Cementless
Primary TKA performed using the LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component
Eligibility Criteria
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Inclusion Criteria
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.
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).
Exclusion Criteria
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.
9. 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).
10. 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.
11. 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.
12. 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.
13. Subjects who have participated previously in this clinical trial and who have been withdrawn.
14. Subject does not meet the indication or is contraindicated for TKA according to specific Smith+Nephew LEGION Knee System IFU.
18 Years
80 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anasua Ganguly
Role: STUDY_CHAIR
Smith & Nephew, Inc.
Locations
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The Core Institute
Phoenix, Arizona, United States
Rothman Orthopedics-Advent Health
Orlando, Florida, United States
Newton Wellesley Hospital
Newton, Massachusetts, United States
New York University Hospital
New York, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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David Markel
Role: primary
Jeff Petrie
Role: primary
Hayden Box
Role: primary
Ran Schwarzkopf
Role: primary
Erik Hansen
Role: primary
Brian Nickel
Role: primary
Other Identifiers
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SNIS-O-1285
Identifier Type: -
Identifier Source: org_study_id