The purpose of this study is to investigate whether subjects receiving a high-flexion knee prosthesis show a better knee function than patients receiving a standard knee prosthesis. Thigh-calf contact force measurements are used to quantify knee function. The investigators' hypothesis is that high-flexion knees show a better knee function.
Study title: Functional evaluation of a standard and a high-flexion knee prosthesis using thigh-calf contact force measurements. Objective: The objective of this study is to investigate whether subjects receiving a high flexion knee prosthesis (Sigma RP-F, J\&J, UK) show a better knee function than patients receiving a standard knee prosthesis (Sigma FB, J\&J, UK). Study Design: Prospective double blind randomized study. Study population: Subjects who will receive total knee arthroplasty (TKA) because of invalidating gonarthritis based on primary osteoarthritis or rheumatic disorders or trauma. Intervention: * 28 subjects will receive the standard Sigma FB knee prosthesis. * 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
67
28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands
Thigh-calf contact force
Time frame: pre-op and 1-year post-op
Passive/active maximal knee flexion angle
Time frame: pre-op and 1-year post-op
BMI, weight and length
Time frame: pre-op and 1-year post-op
Thigh and calf circumference
Time frame: pre-op and 1-year post-op
IKS, WOMAC and VAS (pain/satisfaction) score
Time frame: pre-op and 1-year post-op
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