Total Knee ArthroplastyNCT03720782
Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by Smith & Nephew, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component
- Type of treatment
- Medical device
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2019to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
- 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):
- 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.
- Subject must be available through ten (10) years postoperative follow-up.
- Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English.
Who cannot join
- 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:
- Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
- Subject has ipsilateral hip arthritis resulting in flexion contracture.
- 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.
- 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).
- Subject has a known allergy to one or more of its components of the study device.
Show all 11Show fewer
- 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:
- 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 known to be at risk for loss to follow-up, or failure to return for scheduled visits.
- Subject is found to have had a revision of the study device(s).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Twin Cities Orthopedics
Coon Rapids, Minnesota, 55434
Saint Louis University Hospital, Dept. of Orthopaedic Surgery
St Louis, Missouri, 63104
About this study
Official title: Multi-center Study of the Safety and Performance of Primary Total Knee Arthroplasty With LEGION™ Porous HA Tibial Baseplates (With and Without Holes) and/or the LEGION™ Porous HA CR Femoral Component in US Centers
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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component
- Keywords
- Legion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral ComponentDevice
LEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survivorship 10 years post-surgery
Measured: 10 years
Secondary outcomes (5)
Quality of life - KOOS JR
Patient Reported Outcomes using Knee Injury and Osteoarthritic Outcome Scores (KOOS JR) questionnaire
Measured: 10 years
Quality of Life - Forgotten Joint Score (FJS)
Patient Reported Outcomes using Forgotten Joint Score (FJS) questionnaire
Measured: 10 years
Quality of life - EQ-5D-5L
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire (EQ-5D - 3L) questionnaire
Measured: 10 years
Implant survivorship
Implant Survivorship at 5 years defined as the cumulative proportion of knee-implanted components without a revision
Measured: 5 years
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start22 May 2019
- Primary completion23 Jan 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karlie Morgan, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720782
- Sponsor's protocol ID
- LEGHA.PMCF.2018.07
- Status last verified
- Apr 2026
- First submitted
- 19 Oct 2018
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study of the Safety and Performance of Primary Total Knee Arthroplasty With LEGION™ Porous HA Tibial Baseplates (With and Without Holes) and/or the LEGION™ Porous HA CR Femoral Component in US Centers
- ClinicalTrials.gov ID
- NCT03720782
- Acronym / sponsor ID
- LEGHA.PMCF.2018.07
- Conditions
- Total Knee Arthroplasty
- Keywords
- Legion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2019 (actual)
- Primary completion
- 23 Jan 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
- 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):
- 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.
- Subject must be available through ten (10) years postoperative follow-up.
Key exclusion criteria (11 listed)
- 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:
- Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
- Subject has ipsilateral hip arthritis resulting in flexion contracture.
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral ComponentLEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component | Device | – |
Primary outcome
Implant survivorship 10 years post-surgery
Time frame: 10 years
5 secondary outcomes
Quality of life - KOOS JR
Time frame: 10 years
Quality of Life - Forgotten Joint Score (FJS)
Time frame: 10 years
Quality of life - EQ-5D-5L
Time frame: 10 years
Implant survivorship
Time frame: 5 years
Radiographic findings
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karlie Morgan study chair
Smith & Nephew, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Smith & Nephew, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survivorship 10 years post-surgery (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.