Relation between Component Rotation And Clinical outcomes in total Knee replacement
- Conditions
- Primary knee joint osteoarthritis
- Registration Number
- NL-OMON23362
- Lead Sponsor
- Deventer Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
All mentally competent adult patients who will be treated with total knee replacement for primary knee osteoarthritis (Kellgren and Lawrence grade III or IV);
- Informed consent for the surgical procedure;
- Signed informed consent for the study.
Exclusion Criteria
- Contra-indication for joint replacement surgery in general (pregnancy, active infection, severe cardiac and/or respiratory comorbidities);
- Previous distal femoral or proximal tibial fracture resulting in an altered anatomy;
- Previous osteotomies around the knee resulting in an altered anatomy.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change from baseline OKS at 1-year follow-up in relation to femoral, tibial, and combined component rotation.
- Secondary Outcome Measures
Name Time Method Additional outcome measures include the Knee Injury and Osteoarthritis Outcome Score (KOOS), EQ-5D, VAS pain, the new American Knee Society Score (KSS, version 2011), knee joint range of motion, and complications (i.e. infection).