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

NCT ID: NCT03687593

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-26
• Study Completion Date: 2028-04-01

Brief 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.

Conditions

Total Knee Arthroplasty

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

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

Single arm study, all subjects received the Legion™ CR Femoral Oxinium and CoCr Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karlie Morgan

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Locations

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

Countries

United States

Other Identifiers

17-4042-10

Identifier Type: -

Identifier Source: org_study_id