knee replacement Total knee prosthesis
Conditions
Interventions
None listed
Sponsors
Deventer Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Knee osteoarthritis; - Informed consent for the surgical procedure; - Signed informed consent for the study.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Contra-indication for joint replacement surgery in general (pregnancy, active infection, severe cardiac and respiratory comorbidities); - Previous distal femoral or proximal tibial fracture resulting in an altered anatomy; - Previous osteotomies around the knee resulting in altered anatomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this study are (1) the change from baseline PROMs at 1-year follow-up, and (2) the degree of femoral, tibial and combined component rotation. The following PROMs will be used: - Oxford Knee Score (OKS); - Knee Injury and Osteoarthritis Outcome Score (KOOS); - EQ-5D; - VAS pain. In addition, we will use the clinician-administered American Knee Society Score (AKSS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the range of motion, and early revision because of malposition. | — |
Countries
Netherlands
Outcome results
None listed