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Trials / Not Yet Recruiting

Not Yet RecruitingNCT07199738

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

Status
Not Yet Recruiting
Phase
—
Study type
Observational
Enrollment
144 (estimated)
Sponsor
Smith & Nephew, Inc. · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
DEVICECemented CoCrPrimary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component
DEVICECemented OxiniumPrimary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component
DEVICECementlessPrimary TKA performed using the LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component

Timeline

Start date
2025-11-01
Primary completion
2036-12-01
Completion
2036-12-01
First posted
2025-09-30
Last updated
2025-09-30

Locations

6 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07199738. Inclusion in this directory is not an endorsement.