A Clinical Investigation of the Vanguard™ Complete Knee System

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 Additional exclusion criteria includes: failure of a previous joint replacement

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00698854
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Russell A Schenck, Ph.D.
Principal Investigator Affiliation Clinical Research, Biomet, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Lower Limb Deformity, Complications, Arthroplasty
Additional Details

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, immediate post-operative, 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.

Arms & Interventions

Arms

: Vanguard™ Complete Knee System

Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)

: Vanguard™ Patient-Specific Femur

Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur

Interventions

Device: - Vanguard™ Complete Knee System

Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)

Device: - Vanguard™ Patient-Specific Femur

Primary Total Knee System used with Signature technique to provide a patient-specific femur

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Physicians Clinic of Iowa Orthopedics, Cedar Rapids, Iowa

Status

Address

Physicians Clinic of Iowa Orthopedics

Cedar Rapids, Iowa, 52403

The Orthopaedic Center, Rockville, Maryland

Status

Address

The Orthopaedic Center

Rockville, Maryland, 20850

Advanced Orthopedic Specialists, Cape Girardeau, Missouri

Status

Address

Advanced Orthopedic Specialists

Cape Girardeau, Missouri, 63701

Orthopaedic Associates of Rochester, Rochester, New York

Status

Address

Orthopaedic Associates of Rochester

Rochester, New York, 14626

Texas Orthopedic Specialists, Grapevine, Texas

Status

Address

Texas Orthopedic Specialists

Grapevine, Texas, 76015

Orthopedic Associates, Fishersville, Virginia

Status

Address

Orthopedic Associates

Fishersville, Virginia, 22939

Spokane Orthopedics, Spokane, Washington

Status

Address

Spokane Orthopedics

Spokane, Washington, 99207

Monroe, Wisconsin

Status

Address

Othopaedic & Sports Medicine Clinic of Monroe

Monroe, Wisconsin, 53566