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

June 15, 2015 updated by: Dr. Ahmed Jawhar, Universitätsmedizin Mannheim

Clinical, Biochemical and Neurophysiological Consequences of Intraoperative

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Badenwürtemberg
      • Mannheim, Badenwürtemberg, Germany, 68167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Data
Time Frame: During operation 60 min Ischemia/Shame-Ischemia Time
Measurement of intracellular proteolytic activity
During operation 60 min Ischemia/Shame-Ischemia Time

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Investigators

  • Study Director: Udo Obertacke, Prof. Dr., UMM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-334N-MA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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