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

Primary Purpose

Muscles Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Total knee arthroplasty
Sponsored by
Universitätsmedizin Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Muscles Ischemia

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • UMMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tourniquet

non-tourniquet

Arm Description

Total knee arthroplasty will be performed with tourniquet

Total knee arthroplasty will be performed without tourniquet

Outcomes

Primary Outcome Measures

Biochemical Data
Measurement of intracellular proteolytic activity

Secondary Outcome Measures

Bloodloss
Complications
Clinical Scores
WOMAC-Score, Knee-Score
Radiographic Scores
Prosthesis Position on radiographs
Electrophysiological Evaluation of the N. femoralis
Nerve function analysis

Full Information

First Posted
June 10, 2015
Last Updated
June 15, 2015
Sponsor
Universitätsmedizin Mannheim
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1. Study Identification

Unique Protocol Identification Number
NCT02475603
Brief Title
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty
Official Title
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsmedizin Mannheim

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscles Ischemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tourniquet
Arm Type
Experimental
Arm Description
Total knee arthroplasty will be performed with tourniquet
Arm Title
non-tourniquet
Arm Type
Experimental
Arm Description
Total knee arthroplasty will be performed without tourniquet
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
Total knee arthroplasty
Primary Outcome Measure Information:
Title
Biochemical Data
Description
Measurement of intracellular proteolytic activity
Time Frame
During operation 60 min Ischemia/Shame-Ischemia Time
Secondary Outcome Measure Information:
Title
Bloodloss
Time Frame
1 week postoperative
Title
Complications
Time Frame
6 months postoperative
Title
Clinical Scores
Description
WOMAC-Score, Knee-Score
Time Frame
6 months postoperative
Title
Radiographic Scores
Description
Prosthesis Position on radiographs
Time Frame
1 Week postoperative
Title
Electrophysiological Evaluation of the N. femoralis
Description
Nerve function analysis
Time Frame
1 Week postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Jawhar, Dr
Phone
0621-3834500
Ext
umm
Email
jawhar_ahmed@yahoo.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Udo Obertacke, Prof. Dr.
Organizational Affiliation
UMM
Official's Role
Study Director
Facility Information:
Facility Name
UMM
City
Mannheim
State/Province
Badenwürtemberg
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Jawhar, Dr.
Email
jawhar_ahmed@yahoo.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
25219028
Citation
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.
Results Reference
background
PubMed Identifier
31372679
Citation
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.
Results Reference
derived

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

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