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Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts | Clinical Trials | Clareo Health

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Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Safety and Performance of Primary Total Knee Arthroplasty Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

NCT03687593•Smith & Nephew, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject received primary TKA with the Legion™ CR Femoral Implant (either Oxinium or CoCr) with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, degenerative arthritis, or rheumatoid arthritis).
•2. Subject received primary TKA between 24 and 66 months prior to the time of consent.
•3. Subject agrees to consent and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.
•4. Subject must be available through ten (10) years postoperative follow-up.

Exclusion Criteria

•1. Subject had Body Mass Index (BMI) \> 40 at time of surgery.
•2. Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert as a revision surgery.
•3. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
•4. Subject has a known allergy to one or more of its components of the study device.
•5. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
•6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
•7. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

Locations (4)

Allina Health Systems

Edina, Minnesota, United States

ROC Foundation

Reno, Nevada, United States

Hawkins Foundation

Greenville, South Carolina, United States

Appalachian Orthopedic Associates

Johnson City, Tennessee, United States

Key Dates

Start Date

August 26, 2018

Primary Completion Date

October 1, 2027

Completion Date

April 1, 2028

Last Updated

January 29, 2026

Enrollment

126

ACTUAL participants

Conditions

Total Knee Arthroplasty

Interventions

Legion™ CR Oxinium and CoCr Femoral Implants combined with Legion™/Genesis™ II XLPE High Flex Tibial Inserts

DEVICE

Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome

NCT07456787

Total Knee Arthroplasty\(TKA\)Osteoartrosi

View study

RECRUITINGNA

Mako Cementless TKA vs Mako Cemented TKA

NCT06929871

Total Knee ReplacementTotal Knee Replacement Surgery+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

Inclusion Criteria

Exclusion Criteria

Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome

Mako Cementless TKA vs Mako Cemented TKA

Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty

Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty

Simulation-Based Preoperative Education in Total Knee Arthroplasty

Investigating Patient Satisfaction With Smart Knee Implants