Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-13 @ 11:14 PM
Study NCT ID:
NCT06521593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-26
First Post:
2024-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study
Sponsor:
Kasr El Aini Hospital
Organization:
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:
False
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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: