Knee OsteoarthritisNCT01355900
Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery
A study testing Total knee arthroplasty performed under tourniquet in people with Knee Osteoarthritis, run by Vilnius University at 1 site in Lithuania.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total knee arthroplasty performed under tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteLithuania
- Study dates
- Jan 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Total knee arthroplasty performed under tourniquet
- Keywords
- Total knee arthroplasty, Tourniquet, Blood loss, Volume loading test
- Medical subject headings
- Osteoarthritis, Knee, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty performed under tourniquetProcedure or surgery
Also called Volume loading test
Comparison of the different tourniquet tactics.
| Study group | Role | What they receive |
|---|---|---|
| I tourniquet tactic | Other | 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. Receives: Procedure: Total knee arthroplasty performed under tourniquet |
| II tourniquet tactic | Other | 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. Receives: Procedure: Total knee arthroplasty performed under tourniquet |
| III tourniquet tactic | Other | 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 Receives: Procedure: Total knee arthroplasty performed under tourniquet |
| IV control group | Other | Do not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set. Receives: Procedure: Total knee arthroplasty performed under tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood loss.
The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.
Measured: Before (baseline) the surgery and 24 hrs postoperatively
Secondary outcomes (11)
Wound healing
Measured: Within 6 days postoperatively
Hemodilution
Measured: Within 6 days postoperatively
Cardiac stroke volume
Measured: Within 6 days postoperatively
Body temperature
Measured: Within 6 days postoperatively
Pain (Visual Analog Scale)
Measured: Within 6 days postoperatively
Number of opiate injections
Measured: Within 6 days postoperatively
Straight-leg raising test
Measured: Within 6 days postoperatively
Timed up and go test
Measured: Within 6 days postoperatively
Knee flexion, extension, extension lag
Measured: Within 6 days postoperatively
Knee swelling
Measured: Within 6 days postoperatively
Complications
Measured: Within 6 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Narunas Porvaneckas, Vilnius University
- Investigators
- Narunas Porvaneckas, PhD, Principal investigator, Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355900
- Sponsor's protocol ID
- NP-001
- Status last verified
- Mar 2014
- First submitted
- 16 May 2011
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23052115
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01355900
- Acronym / sponsor ID
- NP-001
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, Tourniquet, Blood loss, Volume loading test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I tourniquet tactic | Other | Procedure: Total knee arthroplasty performed under tourniquetUse 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 | Other | Procedure: Total knee arthroplasty performed under tourniquetUse 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 | Other | Procedure: Total knee arthroplasty performed under tourniquetUse 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 | Other | Procedure: Total knee arthroplasty performed under tourniquetDo not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplasty performed under tourniquetAlso: Volume loading testComparison of the different tourniquet tactics. | Procedure or surgery | I tourniquet tactic, II tourniquet tactic, III tourniquet tactic, IV control group |
Primary outcome
Perioperative blood loss.
Time frame: Before (baseline) the surgery and 24 hrs postoperatively
The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.
11 secondary outcomes
Wound healing
Time frame: Within 6 days postoperatively
Hemodilution
Time frame: Within 6 days postoperatively
Cardiac stroke volume
Time frame: Within 6 days postoperatively
Body temperature
Time frame: Within 6 days postoperatively
Pain (Visual Analog Scale)
Time frame: Within 6 days postoperatively
Number of opiate injections
Time frame: Within 6 days postoperatively
Straight-leg raising test
Time frame: Within 6 days postoperatively
Timed up and go test
Time frame: Within 6 days postoperatively
Knee flexion, extension, extension lag
Time frame: Within 6 days postoperatively
Knee swelling
Time frame: Within 6 days postoperatively
Complications
Time frame: Within 6 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Results publication: PubMed 23052115Kvederas 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narunas Porvaneckas, PhD principal investigator
Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty performed under tourniquet in people with Knee Osteoarthritis, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss. (time frame: Before (baseline) the surgery and 24 hrs postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01355900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.