A Clinical Investigation of the Vanguard™ Complete Knee System
A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System
1 other identifier
observational
552
1 country
8
Brief Summary
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2004
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedSeptember 19, 2024
September 1, 2024
16.8 years
June 13, 2008
September 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
KSS
Knee Society Score Assessment
10 year
Secondary Outcomes (2)
Radiographic Information
10 years
Survivorship
10 years
Study Arms (2)
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
Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
Primary Total Knee System used with Signature technique to provide a patient-specific femur
Eligibility Criteria
Patients in need of relief from painful or disabling joint disease
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (8)
Physicians Clinic of Iowa Orthopedics
Cedar Rapids, Iowa, 52403, United States
The Orthopaedic Center
Rockville, Maryland, 20850, United States
Advanced Orthopedic Specialists
Cape Girardeau, Missouri, 63701, United States
Orthopaedic Associates of Rochester
Rochester, New York, 14626, United States
Texas Orthopedic Specialists
Grapevine, Texas, 76015, United States
Orthopedic Associates
Fishersville, Virginia, 22939, United States
Spokane Orthopedics
Spokane, Washington, 99207, United States
Othopaedic & Sports Medicine Clinic of Monroe
Monroe, Wisconsin, 53566, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kacy C Arnold, RN MBA
Zimmer Biomet
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
March 1, 2004
Primary Completion
January 1, 2021
Study Completion
March 1, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09