Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Tourniquet in Total Knee Replacement Short and Long Duration A Comparative Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tourniquet in Total Knee Replacement Short and Long Duration A Comparative Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Total knee arthroplasty TKA is an effective treatment in severe osteoarthritis We aim to compare the advantages and disadvantages related to the duration of tourniquet application in TKA surgeries
Detailed Description:
Total knee arthroplasty TKA is considered an effective method in relieving pain and regaining function in severe osteoarthritis patients however it is associated with increased blood loss risk which can increase the need for blood transfusion Tourniquet use during surgery is controversial as it provides a clear visualization which decreases the blood loss and ensures proper cementation which makes it used frequently during TKA However its use is associated with complications like nerve palsy thigh pain swelling joint stiffness wound complications subcutaneous fat necrosis vascular injury deep venous thrombosis DVT and prolonged duration of quadriceps recovery
The proper duration of tourniquet application is also controversial as it affects TKA postoperative outcomes as increasing tourniquet application duration can aggravate the complications risk because of the increased tissue exposure to ischemia Therefore minimization of the tourniquet application duration is important which makes researchers investigate if tourniquet application during the cementation process only in TKA could decrease the complications and fasten the recovery
Limited tourniquet application during TKA decreased swelling and joint pain while it was not associated with blood loss recovery or operation time While applying a tourniquet only in cementation could reduce blood loss fasten the recovery period and reduce pain after TKA surgery
However decreasing tourniquet application to be only during cementation was associated with increased blood transfusion risk which indicated that this approach was impractical if there was not any improvement in recovery Therefore a balance should exist between the increased blood loss and blood transfusion risk during cementation tourniquet application Therefore the application time of a tourniquet during cementation in TKA is controversial and no meta-analysis compared using a tourniquet only to the long tourniquet use in TKA surgeries
Therefore randomized controlled trials RCTs are needed to compare which strategy is better which made us perform this study to compare both strategies regarding pain Oxford Knee Score OKS hospital stay pain Knee Society Score KSS blood loss and range of motion ROM
The proper duration of tourniquet application is also controversial as it affects TKA postoperative outcomes as increasing tourniquet application duration can aggravate the complications risk because of the increased tissue exposure to ischemia Therefore minimization of the tourniquet application duration is important which makes researchers investigate if tourniquet application during the cementation process only in TKA could decrease the complications and fasten the recovery
Limited tourniquet application during TKA decreased swelling and joint pain while it was not associated with blood loss recovery or operation time While applying a tourniquet only in cementation could reduce blood loss fasten the recovery period and reduce pain after TKA surgery
However decreasing tourniquet application to be only during cementation was associated with increased blood transfusion risk which indicated that this approach was impractical if there was not any improvement in recovery Therefore a balance should exist between the increased blood loss and blood transfusion risk during cementation tourniquet application Therefore the application time of a tourniquet during cementation in TKA is controversial and no meta-analysis compared using a tourniquet only to the long tourniquet use in TKA surgeries
Therefore randomized controlled trials RCTs are needed to compare which strategy is better which made us perform this study to compare both strategies regarding pain Oxford Knee Score OKS hospital stay pain Knee Society Score KSS blood loss and range of motion ROM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None