This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.
This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study. The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
The Vanguard CR is a metal and polyethylene total condylar knee system. The system contains three primary components: femoral, tibial, and bearing components, and a peripheral component: the patella button.
The AGC knee is a metal and polyethylene total condylar knee system offering complete component interchangeability.
East Sussex Hospital NHS Trust
Saint Leonards-on-Sea, East Sussex, United Kingdom
American Knee Society Knee Score
Objective scoring system to rate the knee and patient's functional abilities before and after TKA
Time frame: 2 year
Patient success
Defined as Knee Score greater than or equal to 80, No component revisions or removals, No pending component revisions or removals, Absence of osteolysis, No migration/subsidence of \>3mm or \>3 degrees
Time frame: 2 year
American Knee Society Score, Oxford Knee-12, SF-12
Objective scoring instruments to rate the knee and patient's functional abilities before and after TKA including scoring systems based on patient questionnaires
Time frame: 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y
Radiographic evaluation
Assessment of patient x-rays
Time frame: 6m,1y, 2y, 3y, 5y, 10y
Adverse Events
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the investigational medical device.
Time frame: any
Survivorship
Implant survivorship based on removal of a study device.
Time frame: 10 years
Noble & Weiss Knee Score, Kujala Score
Scoring systems based on patient questionnaires
Time frame: 6w, 6m, 1y, 2y
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