cartilage damage Osteoarthritis
Conditions
Sponsors
Smith & Nephew Orthopaedics AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing • subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis) • subject is of legal age to consent (>18y), 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
Exclusion criteria
Exclusion criteria: - age > 75 years - 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) - patient has undergone a previous major surgery to the study knee (including but not limited to 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 arthroplasties that are not fully healed and well-functioning, as determined by the investigator - subject has presence of malignant tumor, metastatic, or neoplastic disease - subject has conditions that may interfere with the TKA survival or outcome - 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 BMI>40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Revision for any reason (*revision* will be defined as the exchange of one or more components) | — |
Secondary
| Measure | Time frame |
|---|---|
| - EQ-5D - 2011 KSS - Adverse events - Radiographic evaluation | — |
Countries
Netherlands
Outcome results
None listed