Osteoarthritis, KneePhase 4NCT01832272
Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
A Phase 4 study testing Reinflation after early tourniquet deflation in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Reinflation after early tourniquet deflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Jan 2015
- Phase
- Phase 4
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary osteoarthritis of the knee
- Scheduled for elective total knee arthroplasty
- Written signed consent
Who cannot join
- Revision TKA
- Diagnosis other than primary osteoarthritis
- Intra-articular indwelling drainage
- Refusing participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Tae Kyun Kim, MD, PhD, 82-31-787-7196, osktk@snubh.org
About this study
Official title: The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation. The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.
Read the detailed description
Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet. However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc. Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased. This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time. On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time. The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release. The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again. However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature. Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Reinflation after early tourniquet deflation
- Keywords
- Osteoarthritis, Knee, Total knee arthroplasty, Tourniquet, Early release, Reinflation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinflation after early tourniquet deflationProcedure or surgery
Also called Reinflation after early tourniquet release
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
| Study group | Role | What they receive |
|---|---|---|
| Reinflation after early deflation | Experimental | The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation). Receives: Procedure: Reinflation after early tourniquet deflation |
| No reinflation after early deflation | No intervention | The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Total time between initial skin incision and wound closure
Measured: from skin incision to wound closure
Secondary outcomes (12)
Tourniquet time
Total time of tourniquet-use during the operation which defined from skin incision to the wound closure
Measured: total sum of time between inflation and deflation of tourniquet
Difficulty of the operation
Measured by the number of operative field clearance using gauze to make the remained procedure convenient
Measured: from skin incision to wound closure
Incidence of transfusion
The incidence of allogenic or autologous (preoperative autologous blood donation) transfusion after surgery due to significant hemoglobin drop within 2weeks after surgery
Measured: within 2weeks after surgery
Wound complications
wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing
Measured: on the 2nd and 14th day after surgery
Thigh complications
Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application
Measured: within 2 weeks
Venous thromboembolism
symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery
Measured: within 2 weeks
Postoperative pain (VAS)
An independent investigator who was blinded to randomization assessed knee and thigh pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain) on the 2nd and 5th day after surgery.
Measured: on the 2nd and 5th day after surgery.
More painful site
An independent investigator who was blinded to randomization assessed the more painful site either knee (operation site) or thigh (tourniquet application site) on the 2nd and 5th day after surgery.
Measured: on the 2nd and 5th day after surgery
More painful side in SBTKA
An independent investigator who was blinded to randomization assessed the more painful side in patients undergoing simultaneous bilateral TKA (SBTKA), whose each knee will be allocated into experimental and control group, respectively.
Measured: on the 2nd and 5th day after surgery.
Amount of drainage
Total amount of subcutaneous indwelled drainage before removal of it.
Measured: Until the drainage removal, average of 1 to 2 days after surgery
Hemoglobin drop on the 2nd day after surgery
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value
Measured: On the 2nd day after surgery
Hemoglobin drop on the 5th day after surgery
The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value
Measured: On the 5th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyun Kim, Seoul National University Hospital
- Investigators
- Tae Kyun Kim, MD, PhD, Principal investigator, Joint Reconstruction Center, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832272
- Sponsor's protocol ID
- B-1206/158-004
- Status last verified
- May 2014
- First submitted
- 20 Feb 2013
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01832272
- Acronym / sponsor ID
- B-1206/158-004
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Total knee arthroplasty, Tourniquet, Early release, Reinflation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 16 Apr 2013 (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.
This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation. The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.
Detailed description
Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet. However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc. Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased. This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time. On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time. The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release. The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again. However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature. Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinflation after early deflation | Experimental | Procedure: Reinflation after early tourniquet deflationThe tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation). |
| No reinflation after early deflation | No intervention | –The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary osteoarthritis of the knee
- Scheduled for elective total knee arthroplasty
- Written signed consent
Key exclusion criteria (4 listed)
- Revision TKA
- Diagnosis other than primary osteoarthritis
- Intra-articular indwelling drainage
- Refusing participate
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 |
|---|---|---|
| Reinflation after early tourniquet deflationAlso: Reinflation after early tourniquet releaseThe tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled | Procedure or surgery | Reinflation after early deflation |
Primary outcome
Operation time
Time frame: from skin incision to wound closure
Total time between initial skin incision and wound closure
12 secondary outcomes
Tourniquet time
Time frame: total sum of time between inflation and deflation of tourniquet
Difficulty of the operation
Time frame: from skin incision to wound closure
Incidence of transfusion
Time frame: within 2weeks after surgery
Wound complications
Time frame: on the 2nd and 14th day after surgery
Thigh complications
Time frame: within 2 weeks
Venous thromboembolism
Time frame: within 2 weeks
Postoperative pain (VAS)
Time frame: on the 2nd and 5th day after surgery.
More painful site
Time frame: on the 2nd and 5th day after surgery
More painful side in SBTKA
Time frame: on the 2nd and 5th day after surgery.
Amount of drainage
Time frame: Until the drainage removal, average of 1 to 2 days after surgery
Hemoglobin drop on the 2nd day after surgery
Time frame: On the 2nd day after surgery
Hemoglobin drop on the 5th day after surgery
Time frame: On the 5th day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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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.
Tae Kyun Kim, MD, PhD principal investigator
Joint Reconstruction Center, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reinflation after early tourniquet deflation in people with Osteoarthritis, Knee, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Kyun Kim, MD, PhD (82-31-787-7196, osktk@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: from skin incision to wound closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2014.