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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
NameTimeMethod
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
NameTimeMethod
•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.
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