Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA

Study Overview
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Brief Summary
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Tourniquet application in total knee arthroplasty has many benefits and might have a role in the incidence of peri-operative complications the aim of this research: is to look into the effectiveness of the limited application of tourniquet during primary unilateral total knee arthroplasty and compare the perioperative complications with the standard full-time application.

Detailed Description
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Tourniquet application has been a routine choice for most joint surgeons around the world, reducing intra-operative blood loss and the better clearance of the surgical field and the better cementation technique with a blood-free cancellous bone are the main benefits, while the possible negatives are the pain of the thigh, skin burns, neurovascular complications and possibly increased risk of VTE, and the literature states a new orientation towards reducing the time of application of tourniquet or even eliminating it, favoring avoiding its risks rather than captivating its benefits so the investigator conducted a prospective randomized double-blinded controlled study, and enrolled 62 patients between the beginning of 2021 and august,2022. after obtaining informed consent and approval by the institutional review board, the study was done in Damascus Syria, the investigator followed up every patient for six months, Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups, and the allocation was put into concealed envelopes independent of the surgeon and the author and the randomization was performed by a research fellow who was not involved in patient care, the tourniquet was applicated around the proximal thigh in all patients, the first group went unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application, while the second group went primary unilateral TKA with the tourniquet inflated only during cementation and final components application, the procedures were done under general, spinal or regional anesthesia based on the anesthetist consultant, a based-on-weight tranexamic acid dose was given intravenously before incision, all procedures was done by the same surgeon using the medial para-patellar approach , and the protheses used in all patients were cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing of the patella, intramedullary guides were uses for the femoral and tibial cuts, the patients were blinded to the intervention during the whole period of the study, while the surgeon and the author were unblinded by opening the envelope by a research member just before initiating anesthesia

Official Title
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Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA: a Randomized Controlled Study

Conditions
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Arthritis Knee, Blood Loss, Arthroplasty Complications

Intervention / Treatment
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* Procedure: primary unilateral total knee arthroplasty with limited application of tourniquet
* Procedure: primary unilateral total knee arthroplasty with full application of tourniquet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients between 50 and 85 years of age with end-stage knee arthritis going primary unilateral TKA after the failure of conservative treatment. Exclusion Criteria: o Patients younger than 50y and older than 85y. BMI less than 20 and more than 35. Patients having a vascular or hematologic disease. Patients who were taking anti-coagulant medicine and can't stop it. Patients having acute or chronic renal failure. Patients classified as the AAA as grade four or five. Post-traumatic and secondary knee arthritis patients. Revisions and complex primary cases. Patients with an active infection or a history of lower limp infection.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: limited application<br>Will go primary unilateral TKA with the tourniquet inflated only during cementation and final components of the prosthesis application | Procedure: primary unilateral total knee arthroplasty with limited application of tourniquet<br>* the tourniquet will be applicated around the proximal thigh in all patients before the incision, all patients will undergo primary unilateral TKA by the same surgeon using the medial para-patellar approach, and the prostheses used in all patients will be cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing of the patella, intramedullary guides will be used for the femoral and tibial cuts as seen appropriate by the surgeon, however, the application time of the tourniquet during surgery will be as the allocation of each patient imply.<br>|
| Experimental: full-time application<br>will go unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application | Procedure: primary unilateral total knee arthroplasty with full application of tourniquet<br>* the tourniquet will be applicated around the proximal thigh in all patients before the incision, all patients will undergo primary unilateral TKA by the same surgeon using the medial para-patellar approach, and the prostheses used in all patients will be<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total estimated blood loss | the total amount of lost blood in the perioperative period and will be calculated using the Gross formula which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value | measured once 2 days after surgery | 
| intra-operative blood loss | the amount of lost blood intraoperatively and will be measured by calculating the increased weight of the utilized wet mops and the volume of the suction bottle after erasing the amount of the used lavage | measured once by the time of closure of the incision | 
| post-operative blood loss | the amount of lost blood postoperatively will be calculated as the output of the drain bottle | measured once 2 days after surgery | 
| hidden blood loss | the amount of lost blood in the tissues that were not measured intraoperatively or postoperatively and will be calculated using the difference between total blood loss and intra and post-operative blood loss | measured once 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of surgery | the time of duration of surgery from incision to bandage application measured by minutes | measured once at the time of bandage application after closure | 
| surgical field clearance | surgical field clearance as evaluated by the surgeon | measured once by the time of closure of incision | 
| perioperative complications | like the incidence of infection, VTE, etc | assessed within two weeks intervals until 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, blood loss, tourniquet, complications