Joint replacement /artificial knee due to degeneration, necrosis, fracture etc M17
Conditions
Interventions
Group 1: A Primary total knee arthroplasty (TKA) using EMPOWR 3D knee
system was done 2 years (± 3 months) ago. In agreement with the medical standard demographics and medical history were collected a
Sponsors
Bodden-Kliniken
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Primary total knee arthroplasty (TKA) using EMPOWR 3DTM knee system 2 years (± 3 months). • The patella has not been replaced. • Candidates for knee arthroplasty as per the indication for use from the manufacturer. The EMPOWR 3DTM knee system is indicated for disability due to: o degenerative, post-traumatic or rheumatoid arthritis o avascular necrosis of the femoral condyle o post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy o moderate valgus, varus or flexion deformities o treatment of fractures that are unmanageable using other techniques. • The EMPOWR 3D™ system has been implanted according to the manufacturer’s instructions. • The patient has provided written informed consent. • The patient agrees that the data already collected may be used in the context of this study. • The patient agrees to participate in the above-mentioned follow-up examination. • The patient has a functional understanding of the German language (used in the questionnaires).
Exclusion criteria
Exclusion criteria: •TKA at contralateral site • Secondary surgery performed as a result of previously failed surgical attempts. • Patient was 40 developed after arthroplasty • Patient participates in high physical activity (e.g., competitive sports, heavy physical labour) after TKA. • Patient is a relative of the investigator or of the device manufacturer (Mathys Ltd / Enovis / Encore Medical, L.P.). • Patient is an employee of the site or the device manufacturer (Mathys EMP2024, Version 1.0 of date 01.11.2024 Page 12 of 49 Ltd / Enovis / Encore Medical, L.P.). • Patient is unable to understand the German language (used in questionnaires)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical investigation is to demonstrate that the Dual-Pivot™ EMPOWR 3DTM articulation knee system is effective in maintaining knee stability and patient satisfaction. The outcome will be based on the combined scores from the assessment of radiographic images for knee alignment and patient satisfaction scores, measured with a validated questionnaire (Kujala knee score). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives assess the subjective performance outcomes of the EMPOWR 3DTM Knee System. The outcome will be based on patient quality of life (QoL) scores using a validated questionnaire (SF-12), a pain score (Visual Analog Scale, VAS), and physical performance tests including general appearance rated by the investigator and ROM. The safety objectives will assess the objective maintenance of alignment of the device and the occurrence of safety events. | — |
Countries
Germany
Contacts
Public ContactPatrick Haar
Bodden-Kliniken Ribnitz-Damgarten GmbH
Outcome results
None listed