Primary stability of fully cemented LEGION HK Hinge Knee System in revision total knee arthroplasty measured with RSA
Recruiting
- Conditions
- revisie totale knie arthroplastiek<br />volledig gecementeerde fixatie<br />radiostereometrische analyse<br /><br />revision total knee arthroplasty<br />fully cemented fixation<br />radiostereometric analysis
- Registration Number
- NL-OMON29248
- Lead Sponsor
- Sint Maartenskliniek Nijmegen
- Brief Summary
n/a
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
•Patient requires a revision total knee replacement and the Legion HK system is indicated in this patient.
•Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
Exclusion Criteria
•Patient has a BMI >35.
•Patient has an active, local infection or systemic infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is the stability of the implant fixation in the bone at two years. Stability is measured and will be described by migration of the implant with regard to the (RSA markers in the) bone. <br>
- Secondary Outcome Measures
Name Time Method To assess the functional performance of the Legion HK as revision TKA a set of Patient-Rported Outcome Measures (PROMs) as well as Clinician Reported Outcome Measures (CROMs) will be used. <br /><br><br /><br>- Knee Society Score<br /><br>- Oxford Knee Score<br /><br>- KOOS-PS<br /><br>- VAS pain and VAS satisfaction<br /><br>- Adverse Events