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Active, not recruitingNCT03720782Updated Apr 23, 2026

Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty

An observational study in Total Knee Arthroplasty, sponsored by Smith & Nephew, Inc.. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Smith & Nephew, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
118
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.

02

Conditions studied

  • Total Knee Arthroplasty

Keywords

  • Legion
03

In context

Lead sponsor

Smith & Nephew, Inc. is the lead sponsor of 132 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Maximum of 150 subjects enrolled to obtain a minimum of 150 implanted components:

  • Maximum of 75 subjects to obtain a minimum of 75 implanted tibial baseplate components (with or without holes) to attain 30 evaluable baseplates with holes and 30 evaluable baseplates without holes (i.e. a combined total of 60 evaluable implanted baseplate components)
  • Maximum of 75 subjects to obtain a minimum of 75 implanted LEGION Porous HA CR Femoral Components to attain 60 evaluable components.

Note: Some subjects may have received both the LEGION Porous HA Tibial Baseplate (with or without holes) and the LEGION Porous HA CR Femoral Component during their TKA procedure.

Inclusion criteria

  1. Subject received primary TKA with the LEGION Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis).
  2. Subject received primary TKA between 24 and 60 months prior to the time of consent.

    Inclusion criteria for prospective follow-up (subjects must meet criteria 1 \& 2 from above and criteria 3,4 and 5 below):

  3. Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form.
  4. Subject must be available through ten (10) years postoperative follow-up.
  5. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English.

Exclusion criteria

Exclusion Criteria:

Exclusion criteria for retrospective chart review - Any one (1) of the following criteria will disqualify a potential subject from participation in the retrospective chart review:

  1. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
  2. Subject has ipsilateral hip arthritis resulting in flexion contracture.
  3. At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty.
  4. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
  5. Subject has a known allergy to one or more of its components of the study device.
  6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.

    Exclusion criteria for prospective follow-up - Any one (1) of the criteria from 1-6 above will disqualify a potential subject from participation in the prospective follow-up) as will any one (1) of the below criteria 7, 8 and 9:

  7. 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.
  8. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.
  9. Subject is found to have had a revision of the study device(s).
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
118 participants (actual)
Patient registry
No

Interventions

  • DeviceLEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component

    LEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component

06

What researchers measure

Primary outcomes

  1. Implant survivorship 10 years post-surgery

    Time frame: 10 years

Secondary outcomes

  1. Quality of life - KOOS JR

    Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS JR) questionnaire

    Time frame: 10 years

  2. Quality of Life - Forgotten Joint Score (FJS)

    Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire

    Time frame: 10 years

  3. Quality of life - EQ-5D-5L

    Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire

    Time frame: 10 years

  4. Implant survivorship

    Implant Survivorship at 5 years defined as the cumulative proportion of knee-implanted components without a revision

    Time frame: 5 years

  5. Radiographic findings

    X-ray of implanted knee- 3 views (AP, Lateral and Skyline/Merchant) to observe any radiographic findings that may include; Heterotopic ossification, oteolysis, femoral notching, evidence of poly wear, radiolucencies.

    Time frame: 10 years

07

Study locations

2 sites
  • Twin Cities Orthopedics
    Coon Rapids, Minnesota 55434, United States
  • Saint Louis University Hospital, Dept. of Orthopaedic Surgery
    St Louis, Missouri 63104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03720782
Lead sponsor
Smith & Nephew, Inc.
Responsible party
Sponsor
First posted
Oct 25, 2018
Start date
May 22, 2019
Primary completion
Jan 23, 2031 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Apr 23, 2026

Study contacts

Karlie Morgan
study chair · Smith & Nephew, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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