NCT02475603

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 19, 2015

Status Verified

September 1, 2012

Enrollment Period

2.7 years

First QC Date

June 10, 2015

Last Update Submit

June 15, 2015

Conditions

Muscles Ischemia

Outcome Measures

Primary Outcomes (1)

  • Biochemical Data

    Measurement of intracellular proteolytic activity

    During operation 60 min Ischemia/Shame-Ischemia Time

Secondary Outcomes (5)

  • Bloodloss

    1 week postoperative

  • Complications

    6 months postoperative

  • Clinical Scores

    6 months postoperative

  • Radiographic Scores

    1 Week postoperative

  • Electrophysiological Evaluation of the N. femoralis

    1 Week postoperative

Study Arms (2)

tourniquet

EXPERIMENTAL

Total knee arthroplasty will be performed with tourniquet

Procedure: Total knee arthroplasty

non-tourniquet

EXPERIMENTAL

Total knee arthroplasty will be performed without tourniquet

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplastyPROCEDURE

Total knee arthroplasty

non-tourniquettourniquet

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMM

Mannheim, Badenwürtemberg, 68167, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25219028BACKGROUND

  • 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.

    PMID: 31372679DERIVED

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Udo Obertacke, Prof. Dr.

    UMM

    STUDY DIRECTOR

Central Study Contacts

Ahmed Jawhar, Dr

CONTACT

0621-3834500jawhar_ahmed@yahoo.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 19, 2015

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

January 1, 2016

Last Updated

June 19, 2015

Record last verified: 2012-09

Locations

DE(1)