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Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Total knee arthroplasty performed under tourniquet
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total knee arthroplasty, Tourniquet, Blood loss, Volume loading test

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with osteoarthritis of the knee undergoing total knee arthroplasty with spinal-epidural anesthesia
  • Age > 50 and < 80 years
  • ASA (American Society of Anesthesiology Classification) II physical status
  • Signed informed consent form

Exclusion Criteria:

  • History of a bleeding disorder
  • Current chronic anticoagulation therapy
  • History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
  • Anemia before surgery required blood transfusion
  • ASA I, ASA>=III physical status
  • Age < 50 and > 80 years
  • BMI (Body Mass Index) < 20 and > 40kg/m2
  • Intravascular fluid infusion within 24 hours before study
  • Chronic non-steroidal anti-inflammatory drug use (more than 6month daily use)
  • Rheumatoid arthritis
  • Diabetes mellitus
  • Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors)
  • Alcohol intake 5 U daily
  • Contraindication to epidural catheter insertion
  • Surgery not by project surgeon
  • Participation in the other study
  • Active malignancy
  • Previous open knee surgery

Sites / Locations

  • Republic Vilnius University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

I tourniquet tactic

II tourniquet tactic

III tourniquet tactic

IV control group

Arm Description

Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before incision, deflation- after bone cement set.

Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.

Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before incision, deflation- after wound closure

Do not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.

Outcomes

Primary Outcome Measures

Perioperative blood loss.
The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.

Secondary Outcome Measures

Wound healing
Hemodilution
Cardiac stroke volume
Body temperature
Pain (Visual Analog Scale)
Number of opiate injections
Straight-leg raising test
Timed up and go test
Knee flexion, extension, extension lag
Knee swelling
Complications

Full Information

First Posted
May 16, 2011
Last Updated
March 2, 2014
Sponsor
Vilnius University
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01355900
Brief Title
Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery
Official Title
Influence of the Intraoperative Tourniquet Application Method on the Perioperative Blood Loss, Frequency of Transfusion and Close Postoperative Outcomes in Primary Total Knee Arthroplasty Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Different strategies of tourniquet application during elective primary total knee arthroplasty are thought to be associated with different outcomes. In that context, the study investigates different tactics in the search of optimal application of the tourniquet and the related fluid management during 24 perioperative hours.
Detailed Description
The optimal application of tourniquet should reduce perioperative blood loss, create bloodless operative field, improve cementing technique and shorten surgery time. Meanwhile, inadequate application may increase the risk of deep vein thrombosis and pulmonary thromboembolism. Previous attempts to compare the tourniquet strategies in respect to the perioperative blood loss did not show significant difference. The investigators use the volume loading test aiming to optimize the fluid status and obtain the hemoglobin concentration in the conditions of standardized plasma dilution. The test is deployed just before the surgery and after postoperative 24 hrs in ICU. Functional outcomes and possible length of hospital stay is also evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total knee arthroplasty, Tourniquet, Blood loss, Volume loading test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I tourniquet tactic
Arm Type
Other
Arm Description
Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before incision, deflation- after bone cement set.
Arm Title
II tourniquet tactic
Arm Type
Other
Arm Description
Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.
Arm Title
III tourniquet tactic
Arm Type
Other
Arm Description
Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before incision, deflation- after wound closure
Arm Title
IV control group
Arm Type
Other
Arm Description
Do not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty performed under tourniquet
Other Intervention Name(s)
Volume loading test
Intervention Description
Comparison of the different tourniquet tactics.
Primary Outcome Measure Information:
Title
Perioperative blood loss.
Description
The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.
Time Frame
Before (baseline) the surgery and 24 hrs postoperatively
Secondary Outcome Measure Information:
Title
Wound healing
Time Frame
Within 6 days postoperatively
Title
Hemodilution
Time Frame
Within 6 days postoperatively
Title
Cardiac stroke volume
Time Frame
Within 6 days postoperatively
Title
Body temperature
Time Frame
Within 6 days postoperatively
Title
Pain (Visual Analog Scale)
Time Frame
Within 6 days postoperatively
Title
Number of opiate injections
Time Frame
Within 6 days postoperatively
Title
Straight-leg raising test
Time Frame
Within 6 days postoperatively
Title
Timed up and go test
Time Frame
Within 6 days postoperatively
Title
Knee flexion, extension, extension lag
Time Frame
Within 6 days postoperatively
Title
Knee swelling
Time Frame
Within 6 days postoperatively
Title
Complications
Time Frame
Within 6 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with osteoarthritis of the knee undergoing total knee arthroplasty with spinal-epidural anesthesia Age > 50 and < 80 years ASA (American Society of Anesthesiology Classification) II physical status Signed informed consent form Exclusion Criteria: History of a bleeding disorder Current chronic anticoagulation therapy History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency Anemia before surgery required blood transfusion ASA I, ASA>=III physical status Age < 50 and > 80 years BMI (Body Mass Index) < 20 and > 40kg/m2 Intravascular fluid infusion within 24 hours before study Chronic non-steroidal anti-inflammatory drug use (more than 6month daily use) Rheumatoid arthritis Diabetes mellitus Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors) Alcohol intake 5 U daily Contraindication to epidural catheter insertion Surgery not by project surgeon Participation in the other study Active malignancy Previous open knee surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narunas Porvaneckas, PhD
Organizational Affiliation
Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Republic Vilnius University Hospital
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania

12. IPD Sharing Statement

Citations:
PubMed Identifier
23052115
Citation
Kvederas G, Porvaneckas N, Andrijauskas A, Svensen CH, Ivaskevicius J, Mazunaitis J, Marmaite U, Andrijauskas P. A randomized double-blind clinical trial of tourniquet application strategies for total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2790-9. doi: 10.1007/s00167-012-2221-1. Epub 2012 Sep 28.
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Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery

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