Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™

NCT02380092 | Active Not Recruiting

• 1 other identifier: 12-4042-01
• Study Type: observational
• Target: 163
• Locations: 3 countries
• Sites: 7

Brief 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). 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.

Conditions

Degenerative Joint Disease

Keywords

Knee; Post-Market Surveillance; Legion; Verilast; Degenerative Joint Disease

Outcome Measures

Primary Outcomes (1)

• Survival

  Non-inferiority of survival of Legion Primary with Verilast compared to a literature reference rate of 92.6% for Genesis II TKS

  10 years

Secondary Outcomes (5)

• Number of revisions

  Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years

• Changes in mean 2011 Knee Society Score

  Discharge, 3 months, 1 year, 3 years, 5 years, 10 years

• Changes in mean Euroqol 5-D score

  Discharge, 3 months, 1 year, 3 years, 5 years, 10 years

• Changes in radiographic evaluation

  Discharge, 3 months, 1 year, 3 years, 5 years, 10 years

• AEs

  Operative, Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years

Interventions

LEGION™ Primary TKS with VERILAST™ Bearing Surface DEVICE

All study subjects will be treated with LEGION™ Primary TKS with VERILAST™ Bearing Surface as per standard clinical practice.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are scheduled to have Total Knee Arthroplasty with the Legion Primary Total Knee System due to Degenerative Joint Disease.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (7)

Evangelisches Krankenhaus Wien

Vienna, 1180, Austria

Location

Orthopadische Krankenhaus Gersthof

Vienna, 1180, Austria

Location

AMEOS Klinikum Seepark Geestland

Langen, Kreis Geestland, 27607, Germany

Location

OrthoCentrum

Hamburg, 20149, Germany

Location

CaritasKlinikum St. Joseph Saarbrücken-Dudweiler

Saarbrücken-Dudweiler, 66125, Germany

Location

KniePraxis Prof. Dr. Tibesku

Straubing, 94315, Germany

Location

Servicio de C.O.T. Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Karlie Morgan

  Director of Clinical Study Management, Global Clinical Research Operations

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 5, 2015
• Study Start: September 1, 2015
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

ES (1); AU (2); DE (4)