ncemented tibial component fixation in total knee replacement using porous titanium. A Randomized RSA Study
- Conditions
- cartilage damage10005944Knee arthrosis10023213
- Registration Number
- NL-OMON44792
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
• Patients diagnosed with osteoarthritis or rheumatoid arthritis of the knee requiring primary total knee arthroplasty
• Patients capable of giving Informed Consent and expressing willingness to comply with the post-operative follow-up program
• Patients having no major deformities, i.e. sagittal and coronal deformities are less than 15 degrees
• Patients requiring revision arthroplasty
• Patients unable or unwilling to sign the Patient Informed Consent specific to this study
• Patients with osteoporosis of the tibial plateau
• Patients with functional impairment of any other lower extremity joint besides the operated knee
• Patients having a flexion contracture of 15° and more
• Patients having a varus or valgus contracture of 15° and more
• Patients having insufficient understanding of Dutch language to participate
• Patients incompetent to fill in the clinical scores
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Migration parameters: - Maximum total point migration (MTPM) - Maximum<br /><br>subsidence - Maximum lift-off</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical evaluation: - IKSS (International Knee Society Score)39 - SF36 (Short<br /><br>Form (36) health survey)40 - KOOS (Knee injury and Osteoarthritis Outcome<br /><br>Score)41 - Range of motion of the knee</p><br>