Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low tourniquet pressure | Procedure | Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acquisition of bloodless surgical field just after skin incision | Dichotomous variable determined during operation by operator (Yes or No) | just after skin incision during operation |
| Measure | Description | Time Frame |
|---|---|---|
| Failure of acquiring bloodless surgical field during operation | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| T K Kim, MD, PhD | Contact | 82-31-787-7196 | osktk@snubh.org |
| Name | Affiliation | Role |
|---|---|---|
| T K Kim, MD, PhD | Joint Reconstruction Center, Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Reconstruction Center, Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31159799 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional tourniquet pressure | Procedure | Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation |
|
| 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 | postoperative 2nd day |
| Knee pain | measured by 11-point numerical visual analog scale (VAS)and 5-Likert scale | postoperative 2nd day |
| Skin problem on the site of tourniquet application | It includes ecchymosis, bullae formation and skin necrosis. | posteoperative 2nd day |
| Nerve palsy | 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. | within 7 days after surgery |