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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 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2025-09-30

No results posted yet for this study

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

Interventions

DEVICE

Cemented CoCr

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

DEVICE

Cemented Oxinium

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

DEVICE

Cementless

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

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Anasua Ganguly · Smith & Nephew, Inc.

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2036-12-31
Completion
2036-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07199738 on ClinicalTrials.gov