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

Muscles Ischemia Clinical Trial

Official title:

Clinical, Biochemical and Neurophysiological Consequences of Intraoperative

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02475603
• Other study ID #: 2012-334N-MA
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2015
• Last updated: June 15, 2015
• Start date: September 2012
• Est. completion date: January 2016

Study information

• Verified date: September 2012
• Source: Universitätsmedizin Mannheim
• Contact: Ahmed Jawhar, Dr
• Phone: 0621-3834500
• Email: jawhar_ahmed[@]yahoo.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Muscles Ischemia

Intervention

Procedure:
• Total knee arthroplasty
Total knee arthroplasty

Locations

Country	Name	City	State
Germany	UMM	Mannheim	Badenwürtemberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical Data	Measurement of intracellular proteolytic activity	During operation 60 min Ischemia/Shame-Ischemia Time	No
Secondary	Bloodloss		1 week postoperative	No
Secondary	Complications		6 months postoperative	No
Secondary	Clinical Scores	WOMAC-Score, Knee-Score	6 months postoperative	No
Secondary	Radiographic Scores	Prosthesis Position on radiographs	1 Week postoperative	No
Secondary	Electrophysiological Evaluation of the N. femoralis	Nerve function analysis	1 Week postoperative	No