total knee arthroplasty degenerative joint disease
Conditions
Interventions
Only patients who will be treated with the Journey II BCS knee prosthesis as part of their normally planned care will qualify for this study.
Sponsors
Smith & Nephew Orthopaedics AG
Oberneuhofstrasse 10d
6340 Baar
Switzerland
Eligibility
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, 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 • subject plans to be available through ten (10) years postoperative follow-up
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 of the following athroplasties that are not fully healed and well-functioning, as determined by the investigator: o ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty o contralateral primary total knee or unicondylar knee arthroplasty • subject has presence of malignant tumor, metastatic, or neoplastic disease • subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget’s or Charcot’s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) • 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 For the purpose of this study, “revision” will be defined as the exchange of one or more components. | — |
Secondary
| Measure | Time frame |
|---|---|
| • EQ-5D • 2011 KSS • Adverse events • Radiographic evaluation | — |
Contacts
Public ContactFleur Derdeyn
Smith & Nephew nv Hector Henneaulaan 366
Outcome results
None listed