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

NCT ID: NCT02475603

Last Updated: 2015-06-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-01-31

Brief Summary

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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

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Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis

Conditions

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Muscles Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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tourniquet

Total knee arthroplasty will be performed with tourniquet

Group Type EXPERIMENTAL

Total knee arthroplasty

Intervention Type PROCEDURE

Total knee arthroplasty

non-tourniquet

Total knee arthroplasty will be performed without tourniquet

Group Type EXPERIMENTAL

Total knee arthroplasty

Intervention Type PROCEDURE

Total knee arthroplasty

Interventions

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Total knee arthroplasty

Total knee arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ahmed Jawhar

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Udo Obertacke, Prof. Dr.

Role: STUDY_DIRECTOR

UMM

Locations

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UMM

Mannheim, Badenwürtemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ahmed Jawhar, Dr

Role: CONTACT

0621-3834500 ext. umm

Facility Contacts

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Ahmed Jawhar, Dr.

Role: primary

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.

Reference Type BACKGROUND
PMID: 25219028 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31372679 (View on PubMed)

Other Identifiers

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2012-334N-MA

Identifier Type: -

Identifier Source: org_study_id

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