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

Universitätsmedizin Mannheim

Status: Unknown

Conditions: Muscles Ischemia

Treatments: Procedure: Total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02475603

2012-334N-MA

Details and patient eligibility

About

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

Full description

Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

tourniquet

Experimental group

Description:

Total knee arthroplasty will be performed with tourniquet

Treatment:

Procedure: Total knee arthroplasty

non-tourniquet

Experimental group

Description:

Total knee arthroplasty will be performed without tourniquet

Treatment:

Procedure: Total knee arthroplasty