Skip to content

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

Clinical, Biochemical and Neurophysiological Consequences of Intraoperative

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02475603
Enrollment
100
Registered
2015-06-19
Start date
2012-09-30
Completion date
2016-01-31
Last updated
2015-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscles Ischemia

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

Interventions

PROCEDURETotal knee arthroplasty

Total knee arthroplasty

Sponsors

Universitätsmedizin Mannheim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemical DataDuring operation 60 min Ischemia/Shame-Ischemia TimeMeasurement of intracellular proteolytic activity

Secondary

MeasureTime frameDescription
Electrophysiological Evaluation of the N. femoralis1 Week postoperativeNerve function analysis
Bloodloss1 week postoperative
Complications6 months postoperative
Clinical Scores6 months postoperativeWOMAC-Score, Knee-Score
Radiographic Scores1 Week postoperativeProsthesis Position on radiographs

Countries

Germany

Contacts

Primary ContactAhmed Jawhar, Dr
jawhar_ahmed@yahoo.de0621-3834500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026