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

Part of paid clinical trials in Newton, Massachusetts.

Sponsor
Smith & Nephew, Inc.
Study ID
NCT07199738
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cemented CoCr — DEVICE
    Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component
  • Cemented Oxinium — DEVICE
    Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component
  • Cementless — DEVICE
    Primary TKA performed using the LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component

Study Details

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.

Key Dates

First listed
Sep 30, 2025
Start date
Sep 25, 2025
Status verified
Aug 2026
Primary completion
Dec 31, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
144 participants (estimated)

Arms

  • Arm: Cemented CoCr
    LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component
  • Arm: Cemented Oxinium
    LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component
  • Arm: Cementless
    LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component

Primary Outcome Measure

Implant Survivorship at 10 Years [ Time Frame: 10 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Newton Wellesley HospitalNewtonMassachusetts02462
Hayden Box
[email protected]
617-831-7143
Hayden Box (PRINCIPAL_INVESTIGATOR)
New York University HospitalNew YorkNew York10016
Ran Schwarzkopf
[email protected]
212-513-7711
Ran Schwarzkopf (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Erik Hansen
[email protected]
843-876-0111
Erik Hansen (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53715-1218
Brian Nickel
[email protected]
608-265-9132
Brian Nickel (PRINCIPAL_INVESTIGATOR)

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Newton Wellesley Hospital· Newton, MANew York University Hospital· New York, NYMedical University of South Carolina· Charleston, SCUniversity of Wisconsin· Madison, WI

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