A Clinical Investigation of the Vanguard™ Complete Knee System - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

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.

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Osteoarthritis
Traumatic Arthritis
Rheumatoid Arthritis

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.

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:

Painful and disabled knee joint resulting from osteoarthritis
Rheumatoid arthritis
Traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, or arthrodesis.

Patient selection factors to be considered include:

Need to obtain pain relief and improve function
Ability and willingness of the patient to follow instructions
Including control of weight and activity level
Good nutritional state of the patient
Patient must have reached full skeletal maturity.

Exclusion criteria:

Absolute contraindications include:

Infection
Sepsis
Osteomyelitis
Failure of a previous joint replacement.

Relative contraindications include:

Uncooperative patient or patient with neurologic disorders who are incapable of following directions
Osteoporosis
Metabolic disorders which may impair bone formation
Osteomalacia
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Vascular insufficiency
Muscular atrophy
Neuromuscular disease
Incomplete or deficient soft tissue surrounding the knee.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

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 ^†

Study Director:

Kenneth J Beres, MD

Clinical Research, Biomet Orthopedics, LLC

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.