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

Primary Purpose

Arthritis Knee, Blood Loss, Arthroplasty Complications

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
primary unilateral total knee arthroplasty with limited application of tourniquet
primary unilateral total knee arthroplasty with full application of tourniquet
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis Knee focused on measuring total knee arthroplasty, blood loss, tourniquet, complications

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Damascus university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

limited application

full-time application

Arm Description

Will go primary unilateral TKA with the tourniquet inflated only during cementation and final components of the prosthesis application

will go unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application

Outcomes

Primary Outcome Measures

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
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
post-operative blood loss
the amount of lost blood postoperatively will be calculated as the output of the drain bottle
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

Secondary Outcome Measures

duration of surgery
the time of duration of surgery from incision to bandage application measured by minutes
surgical field clearance
surgical field clearance as evaluated by the surgeon
perioperative complications
like the incidence of infection, VTE, etc

Full Information

First Posted
January 11, 2023
Last Updated
October 22, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05691751
Brief Title
Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA
Official Title
Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
August 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Knee, Blood Loss, Arthroplasty Complications
Keywords
total knee arthroplasty, blood loss, tourniquet, complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
limited application
Arm Type
Experimental
Arm Description
Will go primary unilateral TKA with the tourniquet inflated only during cementation and final components of the prosthesis application
Arm Title
full-time application
Arm Type
Experimental
Arm Description
will go unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application
Intervention Type
Procedure
Intervention Name(s)
primary unilateral total knee arthroplasty with limited application of tourniquet
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
primary unilateral total knee arthroplasty with full application of tourniquet
Intervention Description
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
Primary Outcome Measure Information:
Title
total estimated blood loss
Description
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
Time Frame
measured once 2 days after surgery
Title
intra-operative blood loss
Description
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
Time Frame
measured once by the time of closure of the incision
Title
post-operative blood loss
Description
the amount of lost blood postoperatively will be calculated as the output of the drain bottle
Time Frame
measured once 2 days after surgery
Title
hidden blood loss
Description
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
Time Frame
measured once 2 days after surgery
Secondary Outcome Measure Information:
Title
duration of surgery
Description
the time of duration of surgery from incision to bandage application measured by minutes
Time Frame
measured once at the time of bandage application after closure
Title
surgical field clearance
Description
surgical field clearance as evaluated by the surgeon
Time Frame
measured once by the time of closure of incision
Title
perioperative complications
Description
like the incidence of infection, VTE, etc
Time Frame
assessed within two weeks intervals until 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jaber ibrahim, MD PHD
Organizational Affiliation
Damascus university - faculty of medicine - department of surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
hakam alasaad, MD
Organizational Affiliation
Damascus university - faculty of medicine - department of surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
doried Diri, MD
Organizational Affiliation
Damascus university - faculty of medicine - department of surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damascus university
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
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Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA

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