Complications, Arthroplasty, Lower Limb Deformity, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Keywords
Total Knee Arthroplasty, Total Knee Replacement, Knee Arthritis
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 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.
Interventions
DEVICEVanguard™ Complete Knee System
Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)
DEVICEVanguard™ Patient-Specific Femur
Primary Total Knee System used with Signature technique to provide a patient-specific femur
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KSS | 10 year | Knee Society Score Assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Information | 10 years | Radiographic Evaluation Report |
| Survivorship | 10 years | Knee Society Score Assessment |
Countries
United States
Outcome results
None listed