Clinical, Biochemical and Neurophysiological Consequences of Intraoperative
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Biochemical Data
研究概览
简要总结
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty:
WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis
详细描述
Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age = 55-85 years
- •Osteoarthritis of knee joint (degree III or IV)
- •Physical status (ASA I or II)
- •Body mass index < 45 kg/m²
- •Written informed consent
排除标准
- •Age <55 or > 85years
- •Osteoarthritis knee joint (degree I or II)
- •Physical status (ASA III or IV)
- •Body mass index ≥ 45 kg/m²
- •Unable to provide written consent
- •Malignant disease
- •Rheumatoid disease
- •Infectious disease
- •Coagulation disorder
- •History of deep vein thrombosis or pulmonary embolism
- •Peripheral arterial disease
- •Immune deficiency
- •Medication (Glucocorticoid, Aspirin, Heparin, Cumardine, Wafarin)
- •Neurological dysfunction
- •Liver insufficiency
- •Coronary heart disease
- •Immobility
研究组 & 干预措施
tourniquet
Total knee arthroplasty will be performed with tourniquet
干预措施: Total knee arthroplasty (Procedure)
non-tourniquet
Total knee arthroplasty will be performed without tourniquet
干预措施: Total knee arthroplasty (Procedure)
结局指标
主要结局
Biochemical Data
时间窗: During operation 60 min Ischemia/Shame-Ischemia Time
Measurement of intracellular proteolytic activity
次要结局
- Complications(6 months postoperative)
- Clinical Scores(6 months postoperative)
- Electrophysiological Evaluation of the N. femoralis(1 Week postoperative)
- Radiographic Scores(1 Week postoperative)
- Bloodloss(1 week postoperative)
研究者
Dr. Ahmed Jawhar
Dr
Universitätsmedizin Mannheim