degenerative knee joint Gonarthrosis
Conditions
Interventions
Both groups will undergo total knee arthroplasty. Patients in the intervention
group will receive a Journey II prosthesis. Patients in the control group wil
receive a Genesis II prosthesis.
Sponsors
Orthopedium
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject requires primary total knee arthroplasty due to degenerative joint disease 2. Subject is 18-80 years of age and skeletally mature 3. Subject 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 4. Subject plans to be available through 2 years postoperative follow-up 5. Subject is capable of understanding the Dutch language 6. Subject is able to consent to participate by signing the informed consent form
Exclusion criteria
Exclusion criteria: 1. subject has severe pronation of the ipsilateral foot or any other lower extremity or hip condition causing abnormal ambulation 2. patient has undergone a previous osteotomy or fracture fix 3. subject has active infection or sepsis (treated or untreated) 4. subject has presence of malignant tumor, metastatic, or neoplastic disease 5. subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget*s or Charcot*s disease, vascular insufficiency, severe muscular atrophy, uncontrolled diabetes, severe renal insufficiency or neuromuscular disease) 6. subject has inadequate bone stock to support the device 7. subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective of this study is to determine differences in short term functional outcome and patients perspective of outcome following Total Knee Arthroplasty between the two different total knee prosthesis, measured using the Oxford Knee Score (OKS). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Range of motion of the knee measured using a goniometer * Pain relief, functional abilities, satisfaction and fulfilment of expectations using the Knee Society Score (KSS), KOOS-PS, the Numerical Scale for Pain and Satisfaction (NRS-pain, NRS-satisfaction). * Overall quality of life using the EQ-5D questionnaire * The number of adverse events or the need for revision * The length of hospital stay measured in days | — |
Countries
Netherlands
Outcome results
None listed