Onderzoek naar de draaistabiliteit na plaatsing van totale knieprothese met een voorste kruisband besparende versus niet voorste kruisband besparende totale knieprothese
- Conditions
- Patients who require TKA as a result of gonartrosisPreservation, ACL, PCL, Bi-cruciate, TKA
- Registration Number
- NL-OMON24201
- Lead Sponsor
- Dep. of Orthopedic Surgery, Atrium-Orbis Medical Centre, location Sittard-Geleen.Maastricht University, Dep. Human Movement Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion Criteria
•Cemented application of components
•Patients with pre-existing contra lateral knee surgery
Exclusion Criteria
•Cement less application of components
•BMI greater than or equal to 35
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rotational degrees of freedom of the tibial implant, measured with 3-D motion analysis after operation and compared between the XP tibia implant and CR conventional tibia implant operated with either the MRI-based Signature™ guide or the Conventional alignment
- Secondary Outcome Measures
Name Time Method •Comparing operative, clinical and radiological outcome of the operative procedure with Signature™ and/or the conventional standard intramedullary alignment guides.<br /><br>•Verify the fit, form and practical use of the Signature™ alignment guides. <br /><br>•To determine the occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. Outliers are defined as deviations >3 degrees from preoperative planning.<br /><br>•To determine the occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. Outliers are defined as deviations >3 degrees from preoperative planning.<br /><br>•Verify to what extend the thickness of the in vivo inserted polyethylene corresponds with the pre-operatively calculated thickness of this insert.