A Clinical Investigation of the Vanguard™ Complete Knee System

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00698854
First received: June 13, 2008
Last updated: April 14, 2014
Last verified: April 2014
  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

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

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • KSS [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    Knee Society Score Assessment


Secondary Outcome Measures:
  • X-Ray Data [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2004
Estimated Study Completion Date: January 2026
Estimated Primary Completion Date: January 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts
Vanguard™ Complete Knee System
Vanguard™ Complete Knee System
Vanguard™ Patient-Specific Femur
Vanguard™ Patient-Specific Femur

Detailed Description:

This is a 10-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, 7 year, and 10 year visits 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Missouri
Advanced Orthopedic Specialists
Cape Girardeau, Missouri, United States, 63701
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, Inc.
Investigators
Study Director: Russell A Schenck, Ph.D. Clinical Research, Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00698854     History of Changes
Other Study ID Numbers: Biomet 13594-53
Study First Received: June 13, 2008
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomet, Inc.:
Total Knee Arthroplasty
Total Knee Replacement
Knee Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 31, 2014