Clinical trial NCT06521593: Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study
Official title: Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tourniquet Palsy
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* We included symptomatic grade IV knee primary osteoarthritis cases who were candidates for TKA surgery

Exclusion Criteria:

* we excluded patients with a history of post-infection or traumatic osteoarthritis, knee deformity, hematological diseases, currant infection focus, immune-suppression, or inflammatory arthritis.

Primary outcomes:
measure: Blood loss
timeFrame: immediately post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy hospital
Study officials:
References: