OsteoarthritisNCT01993758
Efficacy of Lower Tourniquet Pressure During Total Knee Arthroplasty
A study testing Low tourniquet pressure and Conventional tourniquet pressure in people with Osteoarthritis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Low tourniquet pressure and Conventional tourniquet pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Jun 2016
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients undergoing total knee arthroplasty
Who cannot join
- Systolic blood pressure measured at ward > 200mmHg
- Thigh circumference > 78cm
- Anesthesia other than spinal anesthesia
- Simultaneous bilateral total knee arthroplasty
- The patients who disagreed the enrollment of this study
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
T K Kim, MD, PhD, 82-31-787-7196, osktk@snubh.org
T K Kim, MD, PhD
About this study
Official title: The Efficacy of Using Lower Tourniquet Pressure During Total Knee Arthroplasty: Comparison With Conventional Tourniquet Pressure Group
This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.
Read the detailed description
We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.
- Conditions
- Osteoarthritis
- Being tested
- Low tourniquet pressure, Conventional tourniquet pressure
- Keywords
- tourniquet pressure, total knee arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low tourniquet pressureProcedure or surgery
Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation
Conventional tourniquet pressureProcedure or surgery
Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation
| Study group | Role | What they receive |
|---|---|---|
| Conventional tourniquet pressure | Active comparator | The patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation. Receives: Procedure: Conventional tourniquet pressure |
| Low tourniquet pressure | Experimental | The patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation. Receives: Procedure: Low tourniquet pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of bloodless surgical field just after skin incision
Dichotomous variable determined during operation by operator (Yes or No)
Measured: just after skin incision during operation
Secondary outcomes (7)
Failure of acquiring bloodless surgical field during operation
Measured: after skin incision through the point of tourniquet deflation
Increasement of tourniquet pressure to acquire bloodless surgical field
We will increase the tourniquet pressure by 30mmHg from the initial tourniquet pressure, if we will fail to achieve bloodless surgical field during operation. The increasement of tourniquet pressure will be recorded if it will be needed during operation.
Measured: after skin incision though the point of tourniquet deflation
Thigh pain on the site of tourniquet application
measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale
Measured: postoperative 2nd day
Knee pain
measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale
Measured: postoperative 2nd day
Skin problem on the site of tourniquet application
It includes ecchymosis, bullae formation and skin necrosis.
Measured: posteoperative 2nd day
Nerve palsy
Measured: within 7 days after surgery
symptomatic venous-thromboembolism
It includes deep vein thrombosis and pulmonary embolism which are symptomatic and diagnosed by confirmative test, such as CT angiogram.
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2016 (estimated)
- Study completionJun 2016 (estimated)
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 OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- T K Kim, MD, PhD, Principal investigator, Joint Reconstruction Center, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993758
- Sponsor's protocol ID
- B-1310/221-007
- Status last verified
- May 2014
- First submitted
- 19 Nov 2013
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim TK, Bamne AB, Sim JA, Park JH, Na YG. Is lower tourniquet pressure during total knee arthroplasty effective? A prospective randomized controlled trial. BMC Musculoskelet Disord. 2019 Jun 4;20(1):275. doi: 10.1186/s12891-019-2636-7.
PubMed 31159799
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Using Lower Tourniquet Pressure During Total Knee Arthroplasty: Comparison With Conventional Tourniquet Pressure Group
- ClinicalTrials.gov ID
- NCT01993758
- Acronym / sponsor ID
- B-1310/221-007
- Conditions
- Osteoarthritis
- Keywords
- tourniquet pressure, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Nov 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 aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.
Detailed description
We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional tourniquet pressure | Active comparator | Procedure: Conventional tourniquet pressureThe patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation. |
| Low tourniquet pressure | Experimental | Procedure: Low tourniquet pressureThe patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients undergoing total knee arthroplasty
Key exclusion criteria (5 listed)
- Systolic blood pressure measured at ward > 200mmHg
- Thigh circumference > 78cm
- Anesthesia other than spinal anesthesia
- Simultaneous bilateral total knee arthroplasty
- The patients who disagreed the enrollment of this study
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 |
|---|---|---|
| Low tourniquet pressureTourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation | Procedure or surgery | Low tourniquet pressure |
| Conventional tourniquet pressureTourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation | Procedure or surgery | Conventional tourniquet pressure |
Primary outcome
Acquisition of bloodless surgical field just after skin incision
Time frame: just after skin incision during operation
Dichotomous variable determined during operation by operator (Yes or No)
7 secondary outcomes
Failure of acquiring bloodless surgical field during operation
Time frame: after skin incision through the point of tourniquet deflation
Increasement of tourniquet pressure to acquire bloodless surgical field
Time frame: after skin incision though the point of tourniquet deflation
Thigh pain on the site of tourniquet application
Time frame: postoperative 2nd day
Knee pain
Time frame: postoperative 2nd day
Skin problem on the site of tourniquet application
Time frame: posteoperative 2nd day
Nerve palsy
Time frame: within 7 days after surgery
symptomatic venous-thromboembolism
Time frame: within 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Derived from this study: PubMed 31159799Kim TK, Bamne AB, Sim JA, Park JH, Na YG. Is lower tourniquet pressure during total knee arthroplasty effective? A prospective randomized controlled trial. BMC Musculoskelet Disord. 2019 Jun 4;20(1):275. doi: 10.1186/s12891-019-2636-7.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
T K 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 study testing Low tourniquet pressure and Conventional tourniquet pressure in people with Osteoarthritis, 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 1 inclusion and 5 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 22 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.
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 T K 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?
Acquisition of bloodless surgical field just after skin incision (time frame: just after skin incision during operation). 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 NCT01993758, 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 22 May 2014.