Journey II BCS Observational Study
- Conditions
- total knee arthroplasty degenerative joint disease
- Registration Number
- NL-OMON27958
- Lead Sponsor
- Smith & Nephew Orthopaedics AGOberneuhofstrasse 10d6340 BaarSwitzerland
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 167
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)
Exclusion Criteria
• age > 75 years
• subjects with immunosuppressive disorders
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Revision for any reason<br>For the purpose of this study, revision” will be defined as the exchange of one or more components.<br><br>
- Secondary Outcome Measures
Name Time Method • EQ-5D<br /><br>• 2011 KSS<br /><br>• Adverse events <br /><br>• Radiographic evaluation<br /><br>