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

NCT07199738 | Not Yet Recruiting FDA Device

• 1 other identifier: SNIS-O-1285
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Keywords

Primary TKA; Osteoarthritis; post-traumatic arthritis; inflammatory arthritis

Outcome Measures

Primary Outcomes (1)

• 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).

  10 years

Secondary Outcomes (6)

• Implant Survivorship

  6 weeks, 1 year, 2 years, 3 years, 5 years, and 7 years

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)

  6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years

• Oxford Knee Score (OKS)

  6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years

• Forgotten Joint Score (FJS)

  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

  6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years

Study Arms (3)

Cemented CoCr

LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component

Device: Cemented CoCr

Cemented Oxinium

LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component

Device: Cemented Oxinium

Cementless

LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component

Device: Cementless

Interventions

Cemented CoCr DEVICE

Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component

Cemented CoCr

Cemented Oxinium DEVICE

Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component

Cemented Oxinium

Cementless DEVICE

Primary TKA performed using the LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component

Cementless

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.
• 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
• month post-operative KOOS JR have been obtained, or these can be collected prospectively in window per schedule of events
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (6)

The Core Institute

Phoenix, Arizona, 85023, United States

Location

Rothman Orthopedics-Advent Health

Orlando, Florida, 32803, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Wisconsin

Madison, Wisconsin, 53715-1218, United States

Location

MeSH Terms

Conditions

Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anasua Ganguly

  Smith & Nephew, Inc.

  STUDY CHAIR

Central Study Contacts

Alice Kitching

CONTACT

+44 7590001182; Alice.Kitching@smith-nephew.com

Galit Reske

CONTACT

+972 54427344; Galit.Reske@smith-nephew.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 30, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: September 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)