A Prospective Multi-center Study on E1 Acetabular Liner in THA
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HHS score
研究概览
简要总结
Evaluate E1 wear, Clinical Performance of E1 liner in THA in Korean Patient Population
详细描述
Total hip arthroplasty (THA) is one of the most successful surgical procedures in general. Yet, a few problems remain unsolved, and aseptic loosening is probably the most important of them. One of the main reasons for aseptic loosening in THA is the foreign body reaction caused by the wear particles. Since the late 1990s, the orthopedic industry has been developing highly crosslinked polyethylene (HXLPE) materials to capitalize on the increased wear resistance. In 2007, E1® Antioxidant Infused Technology was developed to reduce wear rate, maintain mechanical properties and prevent oxidative degradation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in this study if they received Ringloc acetabular system with E1 liner per the approved indications for use by KFDA in Korea. Specifically,
- •Osteoarthritis
- •Avascular necrosis
- •Legg Perthes
- •Rheumatoid Arthritis
- •Diastrophic variant
- •Fracture of the pelvis
- •Slipped capital epiphysis
- •Subcapital fractures
- •Traumatic arthritis Patients aged over 20 Patients with limited co-morbidity - ASA I - III
排除标准
- •Exclusion Criteria for this study should comply with the stated contraindications on package inserts of Ringloc acetabular system with E1 liner. These indications are stated below:
- •Absolute contraindications include: infection, sepsis, and osteomyelitis
- •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, and
- •vascular insufficiency, muscular atrophy, or neuromuscular disease.
结局指标
主要结局
HHS score
时间窗: 1 year
Comparison in clinical outcomes scores between preoperative and various postoperative time points
次要结局
- EQ5D(5 years)
- Modified University of California Los Angeles (UCLA) Activity Score(5 years)
- Radiographic Assessment(5 years)
- Hip Functions(5 years)