Osteoarthritis, Posttraumatic Deformity, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief summary
The primary objectives of this pilot clinical study include: * Evaluate clinical outcomes and quality of life on patients who received Vanguard PS Total Knee in Korean population * Evaluate safety of Vanguard PS Total Knee in Korean population
Detailed description
This study is a prospective, single cohort, multi-center study of Vanguard PS system and will be conducted in Korea with 2 institutions. The study will be conducted over a period of 10 years. Patients will be followed at immediate post-op, 6 weeks, 6 months and 1 year, 3 years. Total of 2 sites will be involved in this study. 50 cases on each sites and total of 100 subjects will be enrolled in the study. Primary end-point will be KSS at 1 year post op and secondary end-points are Survivorship of the product, KSS, EQ5D, High-Flexion Knee Score, Radiographic Assessment, and any kind of complication including lost to follow up.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 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, arthrodesis, or failure of previous joint replacement procedure * Need to obtain pain relief and improve function * Ability and willingness of the patient to follow instructions, including control of weight and activity level * A good nutritional state of the patient, and * The patient must have reached full skeletal maturity (at least 18 years old).
Exclusion criteria
* infection * sepsis * osteomyelitis * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Knee Society Score | 1 year Post Op | Primary Endpoint: Knee Society Score (KSS) at 1 Year Postop |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship | 3 years post op | To access the number of patients with implants |
| EQ-5D | 3 year post op | Quality of life on patients |
| Radiographic Assessment | 3 year Post Op | Access on subsidence, migration, and radiolucency |
| Complications | 3 year Post Op | Any AEs to patients |
Countries
South Korea
Outcome results
None listed