The purpose of the data collection is to document the performance and clinical outcomes of the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard® Knee System using Signature™ Custom Guides and Computer Assisted Surgery. FDA has cleared the Vanguard Knee via premarket notification 510(k) K023546, K033489, and K050222. FDA has cleared the software for the Signature™ Custom Guides via premarket notification 510(k) K073449. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System. Function will be assessed through the Knee Society Score. Survivorship will be documented by asking the surgeon to document revisions and complications.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.
Russells Hall Hospital
Dudley, United Kingdom
Mechanical Alignment
Angle between femoral head, center of knee, and talus.
Time frame: Data Collected at 0-10 Weeks; but Analyzed at Completion of Study
Knee Society Objective Score
Objective Scoring of Knee Society score is the clinical assessment which includes the sum of range of motion, stability, flexion contracture, extension lag, and alignment scores.
Time frame: Completion of Study
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