Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty

Not Applicable

• Conditions: Muscles Ischemia

• 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

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Primary Completion: 2015-06
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-15
• Last Update Submitted: 2015-06-15
• Study First Posted: 2015-06-19
• Last Update Posted: 2015-06-19
• Study Completion: 2016-01

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

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
Radiographic Scores	1 Week postoperative	Prosthesis Position on radiographs
Complications	6 months postoperative
Clinical Scores	6 months postoperative	WOMAC-Score, Knee-Score
Electrophysiological Evaluation of the N. femoralis	1 Week postoperative	Nerve function analysis
Bloodloss	1 week postoperative

Trial Locations

Locations (1)

UMM; 🇩🇪 Mannheim, Badenwürtemberg, Germany