A CLINICAL RANDOMIZED CONTROLLED RSA TRIAL COMPARING THE CEMENTLESS ATTUNE ROTATING PLATFORM KNEE SYSTEM TO THE CEMENTLESS LCS ROTATING PLATFORM KNEE SYSTEM
- Conditions
- Artificial Knee JointTotal Knee Arthroplasty10023213
- Registration Number
- NL-OMON50362
- Lead Sponsor
- Spaarne Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 61
Age: 21- 90 years Indications: Patient is diagnosed with osteoarthritis 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
The patient has an a-priori risk for a posterior-stabilized total knee
arthroplasty.
- Status after patellectomy
- In case flexion is less than 90 degrees 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 Patient is diagnosed with rheumatoid
arthritis 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to compare the magnitude and pattern of<br /><br>migration of the prostheses (Femoral and Tibial component) during the first and<br /><br>second post-operative year. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of this study is to compare clinical and radiological<br /><br>outcome of the prostheses and PROMS and to compare clinical and radiological<br /><br>outcome and PROMS of the prostheses with migration data. </p><br>