A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE (S+Tibia tray) Fixed Bearing Cruciate Retaining Knee System with the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System
- Conditions
- Artificial Knee JointTotal Knee Arthroplasty10023213
- Registration Number
- NL-OMON52817
- Lead Sponsor
- Haaglanden Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
Age: 21- 90 years
Indications: Patient is diagnosed with osteoarthritis or rheumatoid arthritis
and requiring primary knee arthroplasty
General: All consecutive patients (*usual care*) are included to prevent
selection bias in the migration analysis.
Consent: Patient is capable of giving informed consent and expressing a
willingness to comply with this study
The patient has an a-priori risk for a posterior-stabilized total knee
arthroplasty.
Insufficiency of the posterior cruciate ligament (PCL)
Status after patellectomy
In case flexion is less than 90 degrees
When it is expected that the tibia cut during surgery will compromise the
attachment of the PCL (because of
bony defects)
The patient is unable or unwilling to sign the Informed Consent specific to
this study
The patient does not understand the Dutch or English language good enough to
participate
Patients indicated for revision arthroplasty
When there are not enough markers visible in the baseline RSA photograph and it
will not improve by placing
the patient in another position, the patient will be excluded from the study
(secondary exclusion criteria).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Migration, measured by means of RSA.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Patient Reported Outcome Measures by means of questionaires. (PROMS)</p><br>