This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.
The objective of this study is to report and compare on the outcomes from patients undergoing total knee arthroplasty utilizing 'SignatureTM Personalised Patient Care', Conventional Total Knee Arthroplasty and Computer Assisted Navigation. The 'SignatureTM Personalised Patient Care' is a system that uses a patient's Magnetic Resonance Imaging (MRI) and X-ray design to build surgical instruments customized for a patient's unique knee anatomy. Cutting positioning guides are produced to match the outer shape of the individual's distal femur and proximal tibia. The cutting positioning guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Total Knee Arthroplasty performed using Signature Knee Guide
Total Knee Arthroplasty performed using Conventional Instrumentation
Total Knee Arthroplasty performed using Computer Assisted Navigation
Repatriation General Hospital (RGH)
Daw Park, South Australia, Australia
Mechanical Axial Alignment
The primary radiological outcome will be tibial rotation
Time frame: Six months post-operative
Functional outcomes - Knee Society Score
The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.
Time frame: One year post-operative
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