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Tracking Information | |||||
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First Received Date † | June 13, 2008 | ||||
Last Updated Date | April 28, 2009 | ||||
Start Date † | March 2004 | ||||
Current Primary Outcome Measures † |
Knee Society Score [ Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00698854 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
X-rays [ Time Frame: 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Clinical Investigation of the Vanguard™ Complete Knee System | ||||
Official Title † | A Prospective, Non-Controlled, Clinical Investigation of the Vanguard™ Complete Knee System | ||||
Brief Summary | The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System. |
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Detailed Description | This is a 5-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, impo, 6 Month, 1 Year, 3 Year, & 5 Year visit to check on the function, range of motion, and radiographic assessment of their total knee device. The Vanguard Knee is an FDA cleared device, and has been on the market since 2004. |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Cohort, Prospective | ||||
Condition † |
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Intervention † | |||||
Study Arms / Comparison Groups | Vanguard™ Complete Knee System | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Enrolling by invitation | ||||
Estimated Enrollment † | 600 | ||||
Estimated Completion Date | December 2013 | ||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion criteria:
Patient selection factors to be considered include:
Exclusion criteria: Absolute contraindications include:
Relative contraindications include:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00698854 | ||||
Responsible Party | Kenneth Beres, MD Director Clinical Research, Biomet Orthopedics, LLC | ||||
Secondary IDs †† | |||||
Study Sponsor † | Biomet Orthopedics, LLC | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Biomet, Inc. | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |