Degenerative Joint Disease Clinical Trial
Official title:
A Multicentre, Prospective, Post Market Clinical Follow Up Study of the LEGION™ Primary Total Knee System With VERILAST™ Bearing Surface
Verified date | September 2023 |
Source | Smith & Nephew, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 163 |
Est. completion date | May 2029 |
Est. primary completion date | May 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
Austria | Evangelisches Krankenhaus Wien | Wien | |
Austria | Orthopadische Krankenhaus Gersthof | Wien | |
Germany | OrthoCentrum | Hamburg | |
Germany | AMEOS Klinikum Seepark Geestland | Langen | Kreis Geestland |
Germany | CaritasKlinikum St. Joseph Saarbrücken-Dudweiler | Saarbrücken-Dudweiler | |
Germany | KniePraxis Prof. Dr. Tibesku | Straubing | |
Spain | Servicio de C.O.T. Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela |
Lead Sponsor | Collaborator |
---|---|
Smith & Nephew, Inc. |
Austria, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of revisions | Number of revisions (of any component of the device) at all follow up timepoints | Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years | |
Secondary | Changes in mean 2011 Knee Society Score | Changes in mean 2011 Knee Society Score from baseline to each subsequent assessment | Discharge, 3 months, 1 year, 3 years, 5 years, 10 years | |
Secondary | Changes in mean Euroqol 5-D score | Changes in mean Euroqol 5-D score from baseline to each subsequent assessment | Discharge, 3 months, 1 year, 3 years, 5 years, 10 years | |
Secondary | Changes in radiographic evaluation | Changes in radiographic evaluation from baseline to each subsequent assessment | Discharge, 3 months, 1 year, 3 years, 5 years, 10 years | |
Secondary | AEs | Adverse Event reporting from surgery to 10 years post surgery | Operative, Discharge, 3 months, 1 year, 3 years, 5 years, 7 years, 10 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02900781 -
Comparative Effectiveness of an Activity-specific Monitoring Device- StepRite
|
N/A | |
Withdrawn |
NCT01920373 -
Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
|
Phase 1 | |
Completed |
NCT01510457 -
Milnacipran for Chronic Pain in Knee Osteoarthritis
|
Phase 4 | |
Completed |
NCT01010763 -
A Study on M2a Magnum Total Hip Arthroplasty
|
N/A | |
Not yet recruiting |
NCT05229458 -
Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HYALEXO
|
||
Terminated |
NCT02904993 -
Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Arthroplasty
|
N/A | |
Completed |
NCT04399928 -
EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System
|
||
Completed |
NCT01305356 -
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
|
N/A | |
Recruiting |
NCT03090672 -
Cellular & Biocellular Regenerative Therapy in Musculoskeletal Pain, Dysfunction,Degenerative or Inflammatory Disease
|
N/A | |
Not yet recruiting |
NCT04918680 -
Prospective Post-market Study Examining the Effectiveness of the EcoFit®
|
||
Terminated |
NCT01081886 -
PEAK PlasmaBlade 4.0 Versus Traditional Electrosurgery in Total Knee Replacement.
|
N/A | |
Completed |
NCT01540851 -
Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial
|
N/A | |
Withdrawn |
NCT03488147 -
Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery
|
Phase 2 | |
Completed |
NCT01379118 -
Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery
|
N/A | |
Completed |
NCT01391182 -
Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA)
|
N/A | |
Active, not recruiting |
NCT02543437 -
Large Head X3 Study
|
N/A | |
Recruiting |
NCT05357378 -
Safety and Effectiveness of the HIT Reverse HRS
|
N/A | |
Completed |
NCT01970631 -
The Study of Physical Activity Rewards After Knee Surgery
|
N/A | |
Recruiting |
NCT02686528 -
Postoperative Hip Precautions After Total Hip Arthroplasty Via the Posterior Approach: A Prospective Randomized Trial
|
N/A | |
Active, not recruiting |
NCT02211794 -
Journey II BCS EU Observational Trial
|