Degenerative Joint DiseaseNCT02380092
Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™
An observational study of Degenerative Joint Disease, run by Smith & Nephew, Inc. at 7 sites in 3 countries.
Trial summary
LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial insert). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- LEGION™ Primary TKS with VERILAST™ Bearing Surface
- Type of treatment
- Medical device
- How many people
- 163 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Sep 2015to May 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are scheduled to have Total Knee Arthroplasty with the Legion Primary Total Knee System due to Degenerative Joint Disease.
Who may be able to join
- Subject requires primary TKA and has elected to use the LEGION™ Primary TKS with VERILAST™.
- Subject requires primary TKA due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis).
- Subject is of legal age to consent, agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the EC approved informed consent form.
- Routine radiographic assessment is possible.
- Subject plans to be available through ten (10) years postoperative follow-up.
- Subject is 18-75 years of age at the time of surgery.
Who cannot join
- Age > 75 years at the time of surgery.
- Subjects with immunosuppressive disorders.
- Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation (including but not limited to ankle fusion, ankle arthroplasty, previous hip fracture, ipsilateral hip arthritis resulting in flexion contracture).
- Subject has undergone a previous major surgery to the study knee (including osteotomy, fracture fix, medial or lateral ligament surgery).
- Subject has active infection or sepsis (treated or untreated).
- 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:
Show all 18Show fewer
- Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty.
- Contralateral primary total knee or unicondylar knee arthroplasty.
- Subject has presence of malignant tumor, metastatic, or neoplastic disease.
- Subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
- Subject has any acute or chronic morbidity of vascular origin that, in the opinion of the Investigator, is likely to compromise successful treatment or compliance to follow-up visits.
- Subject has inadequate bone stock to support the device (severe osteopenia, family history of severe osteoporosis or osteopenia).
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
- Subject has a Body Mass Index (BMI) >40.0.
- Subject requires revision TKA.
- Subject is expected to require bilateral TKA within 1 year following study knee replacement.
- Subject does not understand the language used in the Informed Consent Form.
- Subject is enrolled in another clinical study at the same time.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany4 sites
OrthoCentrum
Hamburg, 20149
AMEOS Klinikum Seepark Geestland
Langen, Kreis Geestland, 27607
CaritasKlinikum St. Joseph Saarbrücken-Dudweiler
Saarbrücken-Dudweiler, 66125
KniePraxis Prof. Dr. Tibesku
Straubing, 94315
Austria2 sites
Evangelisches Krankenhaus Wien
Vienna, 1180
Orthopadische Krankenhaus Gersthof
Vienna, 1180
Spain1 site
Servicio de C.O.T. Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706
About this study
Official title: A Multicentre, Prospective, Post Market Clinical Follow Up Study of the LEGION™ Primary Total Knee System With VERILAST™ Bearing Surface
LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial insert).
All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing surface and the results will be analysed against historical data from patients who received a Genesis II knee replacement.
Read the detailed description
The LEGION™ Primary Total Knee System (TKS) is a comprehensive, state-of-the-art system that empowers surgeons to address diverse surgical challenges and provide personalized joint care. The LEGION™ Primary TKS implant designs were built on the legacy of the GENESIS™ II TKS. For more than 15 years and in more than 30 countries, the GENESIS™ II TKS has achieved outstanding clinical outcomes.
As CE-mark and 510k approval for the LEGION™ Primary TKS has been obtained, it is being used in clinical practice in several countries including Europe and the US but clinical studies need to be carried out in order to confirm its safety and efficacy and in order to conform to the medical device directives (MEDDEV. 2.7.1 Rev.3).
This study is therefore a post-market study to evaluate the short-, mid- and long-term safety and effectiveness of the LEGION™ Primary TKS with VERILAST™ bearing surface (the combination of an OXINIUM™ femoral component with highly cross-linked polyethylene tibial base plate inserts). The clinical outcome from a large cohort of subjects who are treated with the LEGION™ Primary TKS as part of their standard of care will be documented. The study is designed to reflect standard clinical practice as closely as possible because it allows the results of such a study to represent the true clinical outcome that would be achieved in clinical practice, up to a maximum. Only subjects who will be treated with the LEGION™ Primary TKS as part of their normally planned care will screened for participation in this study.
- Conditions
- Degenerative Joint Disease
- Being tested
- LEGION™ Primary TKS with VERILAST™ Bearing Surface
- Keywords
- Knee, Post-Market Surveillance, Legion, Verilast, Degenerative Joint Disease
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEGION™ Primary TKS with VERILAST™ Bearing SurfaceDevice
All study subjects will be treated with LEGION™ Primary TKS with VERILAST™ Bearing Surface as per standard clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Non-inferiority of survival of Legion Primary with Verilast compared to a literature reference rate of 92.6% for Genesis II TKS
Measured: 10 years
Secondary outcomes (5)
Number of revisions
Number of revisions (of any component of the device) at all follow up timepoints
Measured: Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years
Changes in mean 2011 Knee Society Score
Changes in mean 2011 Knee Society Score from baseline to each subsequent assessment
Measured: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
Changes in mean Euroqol 5-D score
Changes in mean Euroqol 5-D score from baseline to each subsequent assessment
Measured: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
Changes in radiographic evaluation
Changes in radiographic evaluation from baseline to each subsequent assessment
Measured: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
AEs
Adverse Event reporting from surgery to 10 years post surgery
Measured: Operative, Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies 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
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karlie Morgan, Study director, Director of Clinical Study Management, Global Clinical Research Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380092
- Sponsor's protocol ID
- 12-4042-01
- Status last verified
- Dec 2025
- First submitted
- 27 Feb 2015
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Post Market Clinical Follow Up Study of the LEGION™ Primary Total Knee System With VERILAST™ Bearing Surface
- ClinicalTrials.gov ID
- NCT02380092
- Acronym / sponsor ID
- 12-4042-01
- Conditions
- Degenerative Joint Disease
- Keywords
- Knee, Post-Market Surveillance, Legion, Verilast, Degenerative Joint Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- 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.
LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component with highly cross-linked polyethylene tibial insert).
All study subjects will receive a LEGION™ Primary Total Knee System with VERILAST™ bearing surface and the results will be analysed against historical data from patients who received a Genesis II knee replacement.
Detailed description
The LEGION™ Primary Total Knee System (TKS) is a comprehensive, state-of-the-art system that empowers surgeons to address diverse surgical challenges and provide personalized joint care. The LEGION™ Primary TKS implant designs were built on the legacy of the GENESIS™ II TKS. For more than 15 years and in more than 30 countries, the GENESIS™ II TKS has achieved outstanding clinical outcomes.
As CE-mark and 510k approval for the LEGION™ Primary TKS has been obtained, it is being used in clinical practice in several countries including Europe and the US but clinical studies need to be carried out in order to confirm its safety and efficacy and in order to conform to the medical device directives (MEDDEV. 2.7.1 Rev.3).
This study is therefore a post-market study to evaluate the short-, mid- and long-term safety and effectiveness of the LEGION™ Primary TKS with VERILAST™ bearing surface (the combination of an OXINIUM™ femoral component with highly cross-linked polyethylene tibial base plate inserts). The clinical outcome from a large cohort of subjects who are treated with the LEGION™ Primary TKS as part of their standard of care will be documented. The study is designed to reflect standard clinical practice as closely as possible because it allows the results of such a study to represent the true clinical outcome that would be achieved in clinical practice, up to a maximum. Only subjects who will be treated with the LEGION™ Primary TKS as part of their normally planned care will screened for participation in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are scheduled to have Total Knee Arthroplasty with the Legion Primary Total Knee System due to Degenerative Joint Disease.
Key inclusion criteria (6 listed)
- Subject requires primary TKA and has elected to use the LEGION™ Primary TKS with VERILAST™.
- Subject requires primary TKA due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis).
- Subject is of legal age to consent, agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the EC approved informed consent form.
- Routine radiographic assessment is possible.
- Subject plans to be available through ten (10) years postoperative follow-up.
Key exclusion criteria (18 listed)
- Age > 75 years at the time of surgery.
- Subjects with immunosuppressive disorders.
- Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation (including but not limited to ankle fusion, ankle arthroplasty, previous hip fracture, ipsilateral hip arthritis resulting in flexion contracture).
- Subject has undergone a previous major surgery to the study knee (including osteotomy, fracture fix, medial or lateral ligament surgery).
- Subject has active infection or sepsis (treated or untreated).
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™ Primary TKS with VERILAST™ Bearing SurfaceAll study subjects will be treated with LEGION™ Primary TKS with VERILAST™ Bearing Surface as per standard clinical practice. | Device | – |
Primary outcome
Survival
Time frame: 10 years
Non-inferiority of survival of Legion Primary with Verilast compared to a literature reference rate of 92.6% for Genesis II TKS
5 secondary outcomes
Number of revisions
Time frame: Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years
Changes in mean 2011 Knee Society Score
Time frame: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
Changes in mean Euroqol 5-D score
Time frame: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
Changes in radiographic evaluation
Time frame: Discharge, 3 months, 1 year, 3 years, 5 years, 10 years
AEs
Time frame: Operative, Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 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 15 Dec 2025.
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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 director
Director of Clinical Study Management, Global Clinical Research Operations
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Joint Disease, run by Smith & Nephew, Inc. at 7 sites in 3 countries.
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 18 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria, Spain. 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?
Survival (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 15 Dec 2025.