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

Sponsored by:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00698854

Purpose

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.

Condition
Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Prospective, Non-Controlled, Clinical Investigation of the Vanguard™ Complete Knee System

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Knee Society Score [ Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

X-rays [ Time Frame: 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	March 2004
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Vanguard™ Complete Knee System 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients in need of relief from painful or disabling joint disease

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698854

Locations

United States, Iowa
Physicians Clinic of Iowa Orthopedics
Cedar Rapids, Iowa, United States, 52403
United States, Maryland
The Orthopaedic Center
Rockville, Maryland, United States, 20850
United States, New York
Orthopaedic Associates of Rochester
Rochester, New York, United States, 14626
United States, Texas
Texas Orthopedic Specialists
Grapevine, Texas, United States, 76015
United States, Virginia
Orthopedic Associates
Fishersville, Virginia, United States, 22939
United States, Washington
Spokane Orthopedics
Spokane, Washington, United States, 99207
United States, Wisconsin
Othopaedic & Sports Medicine Clinic of Monroe
Monroe, Wisconsin, United States, 53566

Sponsors and Collaborators

Biomet Orthopedics, LLC

Investigators

Study Director:

Kenneth J Beres, MD

Clinical Research, Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, LLC ( Kenneth Beres, MD Director Clinical Research )
Study ID Numbers:	Biomet 13594-53
Study First Received:	June 13, 2008
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00698854 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Total Knee Arthroplasty
Total Knee Replacement
Knee Arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009