The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement with a good clinical track record and good survival rates. The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. It is expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval early 2016. Patient inclusion will start after regular approval has been obtained. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32 patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95% is Osteo Arthritis (OA). The investigator anticipates that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are: * Migration, measured by means of RSA. * Patient Reported Outcome Measures by means of questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy
Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy
Spaarne Gasthuis
Hoofddorp, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Migration, measured by means of RSA
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).
Time frame: 2 Years
EQ-5D
General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire
Time frame: 2 Years
KOOS
Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire
Time frame: 2 Years
VAS pain
Pain score after activity and during rest; (Likert scale 0-10)
Time frame: 2 Years
2 Anchor questions
Two anchor questions (Likert scale 1-7) about change in functioning and pain since surgery.
Time frame: 2 Years
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