Safety and Performance Using Legion™ CR Oxinium and CoCr... | NCT03687593

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

NCT03687593

Sponsor

Smith & Nephew, Inc.

Status

Active, not recruiting

Last Update Posted

Jan 29, 2026Actual

Enrollment

126Actual

Phase

Not provided

Conditions

Total Knee Arthroplasty

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2018Actual

Primary Completion Date

Oct 1, 2027Estimated

Completion Date

Apr 1, 2028Estimated

First Submitted Date

Sep 26, 2018

First Submission Date that Met QC Criteria

Sep 26, 2018

First Posted Date

Sep 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Jan 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Measure	Description	Time Frame
Implant survival 10 years postoperatively		10 years post-op

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Allina Health Systems		Edina	Minnesota	55439	United States
ROC Foundation