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

NCT03687593 | Active Not Recruiting

• 1 other identifier: 17-4042-10
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Implant survival 10 years postoperatively

  10 years post-op

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will screen all subjects who underwent TKA with the LEGION™ CR Oxinium and CoCR Femoral Implants

You may qualify if:

• 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).
• Subject received primary TKA between 24 and 66 months prior to the time of consent.
• 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.
• Subject must be available through ten (10) years postoperative follow-up.

You may not qualify if:

• Subject had Body Mass Index (BMI) \> 40 at time of surgery.
• Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert as a revision surgery.
• 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).
• Subject has a known allergy to one or more of its components of the study device.
• 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.
• Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
• Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (4)

Allina Health Systems

Edina, Minnesota, 55439, United States

Location

ROC Foundation

Reno, Nevada, 89503, United States

Location

Hawkins Foundation

Greenville, South Carolina, 29615, United States

Location

Appalachian Orthopedic Associates

Johnson City, Tennessee, 37604, United States

Location

Study Officials

• Karlie Morgan

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: August 26, 2018
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (4)