Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty
Not Applicable
- Conditions
- Muscles Ischemia
- Interventions
- Procedure: Total knee arthroplasty
- Registration Number
- NCT02475603
- Lead Sponsor
- Universitätsmedizin Mannheim
- Brief Summary
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
- Detailed Description
Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tourniquet Total knee arthroplasty Total knee arthroplasty will be performed with tourniquet non-tourniquet Total knee arthroplasty Total knee arthroplasty will be performed without tourniquet
- Primary Outcome Measures
Name Time Method Biochemical Data During operation 60 min Ischemia/Shame-Ischemia Time Measurement of intracellular proteolytic activity
- Secondary Outcome Measures
Name Time Method Complications 6 months postoperative Bloodloss 1 week postoperative Radiographic Scores 1 Week postoperative Prosthesis Position on radiographs
Clinical Scores 6 months postoperative WOMAC-Score, Knee-Score
Electrophysiological Evaluation of the N. femoralis 1 Week postoperative Nerve function analysis
Trial Locations
- Locations (1)
UMM
🇩🇪Mannheim, Badenwürtemberg, Germany