Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief summary
The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.
Detailed description
The primary objectives of this clinical study include: * Evaluate size fit and long term performance of Vanguard Complete Knee (Fixed) System in Asian and Latino population in comparison to competitor's similar product. * Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray. * Compare Vanguard High Flex Rotating Platform (High Flex) Knee System to Vanguard Complete Knee System in Asian population in terms of: * Early ROM * Clinical outcomes * Kinetic and Kinematic characteristics in relation to Healthy Knees. o * Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of : * Early ROM * Clinical outcomes * Kinetic and Kinematic characteristics
Interventions
DEVICEVanguard Complete Knee
Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.
DEVICEVanguard High Flex RP
Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion.
Sponsors
Zimmer Biomet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Painful and disabled knee joint resulting form 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. * 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
* Infection, sepsis, osteomyelitis, and failure of previous joint replacement. * Uncooperative patient or patients 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Knee Society Knee Score | 1 Year postop | Including ROM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinematic Fluoroscopic Analysis | 3 yr | Kinematic Fluoroscopic Analysis |
| Gait Lab Analysis | 3 yr | Gait Lab Analysis |
| EQ5D | 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr | Quality of Life |
| Radiographic Assessment | immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr | Radiographic Assessment |
Countries
South Korea
Outcome results
None listed