Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty
NCT ID: NCT02475603
Last Updated: 2015-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2012-09-30
2016-01-31
Brief Summary
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WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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tourniquet
Total knee arthroplasty will be performed with tourniquet
Total knee arthroplasty
Total knee arthroplasty
non-tourniquet
Total knee arthroplasty will be performed without tourniquet
Total knee arthroplasty
Total knee arthroplasty
Interventions
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Total knee arthroplasty
Total knee arthroplasty
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
85 Years
ALL
Yes
Sponsors
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Universitätsmedizin Mannheim
OTHER
Responsible Party
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Dr. Ahmed Jawhar
Dr
Principal Investigators
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Udo Obertacke, Prof. Dr.
Role: STUDY_DIRECTOR
UMM
Locations
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UMM
Mannheim, Badenwürtemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Girard N. Evidence appraisal of Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014;9(1):13. http://www.josr-online.com/content/9/1/13. Accessed May 30, 2014. AORN J. 2014 Aug;100(2):224-8. doi: 10.1016/j.aorn.2014.06.003. No abstract available.
Jawhar A, Skeirek D, Stetzelberger V, Kollowa K, Obertacke U. No effect of tourniquet in primary total knee arthroplasty on muscle strength, functional outcome, patient satisfaction and health status: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1045-1054. doi: 10.1007/s00167-019-05646-5. Epub 2019 Aug 1.
Other Identifiers
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2012-334N-MA
Identifier Type: -
Identifier Source: org_study_id
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