ncemented tibial component fixation in total knee replacement using porous titanium. A Randomised RSA Study

• Conditions: cartilage damage; Knee arthrosis; 10023213; 10005944

• Registration Number: NL-OMON36423
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

•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

Exclusion Criteria

•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:<br /><br>- Maximum total point migration (MTPM)<br /><br>- Maximum subsidence<br /><br>- Maximum lift-off</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical evaluation:<br /><br>- IKSS (International Knee Society Score)39<br /><br>- SF36 (Short Form (36) health survey)40<br /><br>- KOOS (Knee injury and Osteoarthritis Outcome Score)41<br /><br>- Range of motion of the knee</p><br>