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

Sponsor

Damascus University (Other)

Overall Status

Completed

CT.gov ID

NCT05691751

Collaborator

(none)

Enrollment

Location

Arms

19.7

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis Knee Blood Loss Arthroplasty Complications	Procedure: primary unilateral total knee arthroplasty	N/A

Detailed Description

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 We conducted a prospective randomized double-blinded controlled study, we 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, we 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

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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 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, the data was collected by the author's assistant who was blinded of the intervention during the whole period of the study

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Aug 23, 2022

Actual Study Completion Date :

Aug 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: limited application 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 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.
Experimental: full-time application 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 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.

Arm

Intervention/Treatment

Experimental: limited application

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

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.

Experimental: full-time application

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

Outcome Measures

Primary Outcome Measures

total estimated blood loss [measured once 2 days after surgery]
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
intra-operative blood loss [measured once by the time of closure of the incision]
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
post-operative blood loss [measured once 2 days after surgery]
the amount of lost blood postoperatively will be calculated as the output of the drain bottle
hidden blood loss [measured once 2 days after surgery]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damascus university	Damascus		Syrian Arab Republic

Sponsors and Collaborators

Damascus University

Investigators

Study Chair: jaber ibrahim, MD PHD, Damascus university - faculty of medicine - department of surgery
Study Director: hakam alasaad, MD, Damascus university - faculty of medicine - department of surgery
Principal Investigator: doried Diri, MD, Damascus university - faculty of medicine - department of surgery