Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jan 2010
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
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
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMarch 4, 2014
March 1, 2014
4 years
May 16, 2011
March 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perioperative blood loss.
The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.
Before (baseline) the surgery and 24 hrs postoperatively
Secondary Outcomes (11)
Wound healing
Within 6 days postoperatively
Hemodilution
Within 6 days postoperatively
Cardiac stroke volume
Within 6 days postoperatively
Body temperature
Within 6 days postoperatively
Pain (Visual Analog Scale)
Within 6 days postoperatively
- +6 more secondary outcomes
Study Arms (4)
I tourniquet tactic
OTHERUse 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.
II tourniquet tactic
OTHERUse 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.
III tourniquet tactic
OTHERUse 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
IV control group
OTHERDo not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.
Interventions
Comparison of the different tourniquet tactics.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vilnius Universitylead
- Karolinska Institutetcollaborator
Study Sites (1)
Republic Vilnius University Hospital
Vilnius, LT-04130, Lithuania
Related Publications (1)
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.
PMID: 23052115RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Narunas Porvaneckas, PhD
Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pofessor, PhD
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 18, 2011
Study Start
January 1, 2010
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 4, 2014
Record last verified: 2014-03