M17
Conditions
Interventions
Group 1: All patients undergo total knee arthroplasty with an EMPOWR 3D knee System (Encore Medical, L.P.). Clinical and radiological short-to long-term safety and performance are collected after 3 or
Sponsors
Mathys Ltd Bettlach
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The patient has given his/her written consent to participate after having been fully informed (informed consent of the patient) is a candidate for a primary bicondylar knee endoprosthesis suffers from a painful and / or disabling bicompartmental joint disease in the femorotibial compartment resulting from osteoarthritis, avascular necrosis, or post-traumatic arthritis The patient is willing to participate in the follow-up examinations mentioned
Exclusion criteria
Exclusion criteria: Missing informed consent form (signed by participant and investigator) Incapacitated subjects (individuals who are not able to give informed consent due to a mental disability) Minors (< 18 years) Is pregnant, desires to have children or is in the breast-feeding period during the study period Patients in emergency situations (includes sudden life-threatening or other sudden serious medical condition (e.g. unconsciousness) preventing the patient from giving informed consent Known or suspected non-compliance of eligibility criteria (e.g. drug or alcohol abuse) Simultaneous participation in another clinical study or documentation with medical devices or drugs which could have an influence on the current study Non-compliance with clinical investigation-related processes (such as diagnosis and therapy). Enrolment of the investigator, his/her family, employees (MAB/ investigational site) and other dependent persons Geriatric subjects at inclusion Prisoners at inclusion Other patient groups considered particularly vulnerable to such substances and/or materials Infection (or a history of infection), acute or chronic, local or systemic Insufficient bone quality which may affect the stability of the implant Muscular, neurological or vascular deficiencies, which compromise the affected extremity Obesity Loss of ligamentous structures Insufficient soft tissue integrity to provide adequate stability High levels of physical activity (e.g. competitive sports, heavy physical labor) Less understanding of the German language which will be used within questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study will be the New Knee Society Score (NKSS), evaluated at two years postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will be the radiographic evaluation, the Visual Analogue Scale (VAS) measuring pain, VAS measuring satisfaction, Forgotten Joint Score (FJS-12) and Short Form-12 (SF-12). | — |
Countries
Germany
Contacts
Public ContactGeorgi Wassilew
Universitätsmedizin Greifswald - Körperschaft des öffentlichen Rechts - Klinik und Poliklinik für Orthopädie und Orthopädische Chirurgie
Outcome results
None listed