NCT03687593

Active Not Recruiting

Safety and Performance Using Legion™ CR Oxinium and CoCr Fem...

Smith & Nephew, Inc.Source

Compare

Other study identifiers

Sponsor study identifier

17-4042-10

Study Type

observational

Actual enrollment (reported)

126

Locations

1 country

Sites

4

Timeline

Study Start

August 26, 2018

Actual (reported)

Primary Completion

October 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

April 1, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Actual enrollment (reported): 126 participants
Study completion date: April 1, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 4 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 26, 2018
Actual (reported)
First Submitted
September 26, 2018
Actual (reported)
First Posted
September 27, 2018
Actual (reported)
Primary Completion
October 1, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: January 29, 2026
Status Verified: January 2026
Last Update Submitted: January 27, 2026

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 InsertsDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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).

Sponsors & Collaborators

Smith & Nephew, Inc.
Industrylead

Study Sites (4)

Allina Health Systems

Edina, Minnesota, 55439, United States

ROC Foundation

Reno, Nevada, 89503, United States

Hawkins Foundation

Greenville, South Carolina, 29615, United States

Appalachian Orthopedic Associates

Johnson City, Tennessee, 37604, United States

Study Officials

Karlie Morgan
Smith & Nephew, Inc.
STUDY DIRECTOR

Enrollment

126 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT03607461

Using a Smartphone App to Aid in Functional Mobility Return Following Total Knee Arthroplasty

Not ApplicableUnknown

NCT03703206

The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)

Phase 3Completed

NCT05900453

Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

Completed

NCT05653102

A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System

Recruiting

NCT03768206

The PATH Study to Promote Physical Activity After Knee Replacement

Not ApplicableCompleted

NCT03928522

Antibiotic Elution in Total Knee Arthroplasty

Phase 4Completed

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.

Contact the study team to confirm eligibility.

Primary Completion

October 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

April 1, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

January 29, 2026

Record last verified: 2026-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03687593
Data provider: ClinicalTrials.gov
Source updated: 2026-01-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:37 UTC

Locations

US(4)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations