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

October 22, 2023 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 with limited application of tourniquet
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 with full application of tourniquet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total estimated blood loss
Time Frame: 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
measured once 2 days after surgery
intra-operative blood loss
Time Frame: 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
measured once by the time of closure of the incision
post-operative blood loss
Time Frame: measured once 2 days after surgery
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
Time Frame: 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
measured once 2 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

August 23, 2022

Study Completion (Actual)

August 23, 2022

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-Orthopedics-1-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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