East Sussex Hospital NHS Trust
Saint Leonards-on-Sea, East Sussex, TN37 7RD, United Kingdom
NCT Number: NCT01064063
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Saint Leonards-on-Sea, East Sussex, TN37 7RD, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 year
Objective scoring system to rate the knee and patient's functional abilities before and after TKA
Time frame: 2 year
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: 6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y
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: 6m,1y, 2y, 3y, 5y, 10y
Assessment of patient x-rays
Time frame: any
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: 10 years
Implant survivorship based on removal of a study device.
Time frame: 6w, 6m, 1y, 2y
Scoring systems based on patient questionnaires
Zimmer Biomet
Industry
Acronym: Vanguard
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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