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

December 1, 2023 updated by: Smith & Nephew, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Edina, Minnesota, United States, 55439
        • Allina Health Systems
    • Nevada
      • Reno, Nevada, United States, 89503
        • ROC Foundation
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Hawkins Foundation
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Appalachian Orthopedic Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Implant survival 10 years postoperatively
Time Frame: 10 years post-op
10 years post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Study Director: Rachael Winter, Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2018

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 17-4042-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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