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

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ClinicalTrials.gov Identifier: NCT02475603
Recruitment Status : Unknown
Verified September 2012 by Dr. Ahmed Jawhar, Universitätsmedizin Mannheim.
Recruitment status was:  Recruiting
First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Ahmed Jawhar, 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


Condition or disease Intervention/treatment Phase
Muscles Ischemia Procedure: Total knee arthroplasty Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Clinical, Biochemical and Neurophysiological Consequences of Intraoperative
Study Start Date : September 2012
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: tourniquet
Total knee arthroplasty will be performed with tourniquet
Procedure: Total knee arthroplasty
Total knee arthroplasty

Experimental: non-tourniquet
Total knee arthroplasty will be performed without tourniquet
Procedure: Total knee arthroplasty
Total knee arthroplasty




Primary Outcome Measures :
  1. Biochemical Data [ Time Frame: During operation 60 min Ischemia/Shame-Ischemia Time ]
    Measurement of intracellular proteolytic activity


Secondary Outcome Measures :
  1. Bloodloss [ Time Frame: 1 week postoperative ]
  2. Complications [ Time Frame: 6 months postoperative ]
  3. Clinical Scores [ Time Frame: 6 months postoperative ]
    WOMAC-Score, Knee-Score

  4. Radiographic Scores [ Time Frame: 1 Week postoperative ]
    Prosthesis Position on radiographs

  5. Electrophysiological Evaluation of the N. femoralis [ Time Frame: 1 Week postoperative ]
    Nerve function analysis



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475603


Contacts
Contact: Ahmed Jawhar, Dr 0621-3834500 ext umm jawhar_ahmed@yahoo.de

Locations
Germany
UMM Recruiting
Mannheim, Badenwürtemberg, Germany, 68167
Contact: Ahmed Jawhar, Dr.       jawhar_ahmed@yahoo.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Study Director: Udo Obertacke, Prof. Dr. UMM

Publications:
Responsible Party: Dr. Ahmed Jawhar, Dr, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02475603     History of Changes
Other Study ID Numbers: 2012-334N-MA
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: September 2012

Additional relevant MeSH terms:
Ischemia
Pathologic Processes