Comparing the migration and inducible displacement through RSA of the cementless ATTUNETM Rotating Platform and the cementless LCS Rotating Platform Knee system; A Clinical Randomized Controlled RSA follow-up study*
Phase 4
- Conditions
- Total Knee ArthroplastyArtificial Knee Joint10023213
- Registration Number
- NL-OMON51661
- Lead Sponsor
- Spaarne Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 52
Inclusion Criteria
- All patients that participated in the initial study (NL58911.058.16)
- Patient that are capable of giving informed consent and expressing a
willingness to comply with the study.
Exclusion Criteria
- The patient underwent a major revision TKR (exchange of the tibial or femoral
component).
- The patient is unable or unwilling to sign the informed consent specific to
this study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Migration measured with RSA</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Inducible displacement measured with RSA.<br /><br>- Patient-reported satisfaction is measured by questionnaires.<br /><br>- Clinical and radiographic outcomes are measured by physical examination and<br /><br>RSA radiographs.</p><br>