Evaluation Effectiveness of the Aesculap® Plasmafit Cementless Acetabular System in Combination With Vitelene® Polyethylene and Vitamin E Insert for Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Functional assessments of hip joint replacement over time with Harris Hip Score (HHS)
研究概览
简要总结
Objectives of this study is evaluate effectivness of AESCULAP® Plasmafit® Plasmafit Cementless Acetabular System With Vitelene® Vitamin E Stabilized Highly Crosslinked Polyethylene compare to the sane sistem without Vitamin E, and ceramic or metal femoral heads
详细描述
Osteoarthritis is one most common disease in aged population, that most advanced stage needs surgical treatment. Surgical treatment usually include installation of implants. Every year new types of implants were fabricated from the new material. The effectiveness of this new devices need carefully independent assess in clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who needs total knee replacement surgery
- •Informed consent from the patients.
排除标准
- 未提供
结局指标
主要结局
Functional assessments of hip joint replacement over time with Harris Hip Score (HHS)
时间窗: 3 year follow-up
The HHS is a measure of dysfunction of the hip joint. Consist of 10 items in 3 sections. Score \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Functional assessments of knee joint replacement over time with Knee Society Score (KSS)
时间窗: 3 year follow-up
The KSS is a measure of dysfunction of the knee joint. The KSS has a two sections: "Knee Score" section (7 items) and a "Functional Score" section (3 items). Results can be interpreted with the following: 80-100 = excellent; score 70-79 = good; score 60-69 = fair; score \<60 = poor.
Forgotten Joint Score-12 (FJS-12) for knee joint, modified Rankin scale
时间窗: 3 year follow-up
FJS-12 shows how much did the patient forget their artificial joint. Consists of 12 items, each item is answered within a 5-point Likert scale, as follows: 0: never (0 p); almost never (1 p); seldom (2 p); sometimes (3 p); and mostly (4 p). The initial raw data were converted to a scale ranging from 0 to 100 (worst to best).
The modified Rankin scale (mRS)
时间窗: 3 year follow-up
mRS was used scale for measuring the degree of disability or dependence in the daily activities after joint replacement, with the following response options: 0: No symptoms at all; 1: No significant disability despite symptoms; able to carry out all usual duties and activities; 2: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate disability; requiring some help, but able to walk without assistance; 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6: Dead
Measuring postoperative pain using the visual analog scale for pain (VAS-P)
时间窗: 3 year follow-up
To measure pain intensity after surgery the patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain).
次要结局
- Revision surgery(1 year follow-up)
- Rentgenological assessments knee and hip replacement over time(3 year follow-up)
- The assessment of the assessment of quality of life(3 year follow-up)
- Postoperative complications(3 year follow-up)
- The quality-adjusted life-year(3 year follow-up)