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

NCT05691751 | Completed

• 1 other identifier: UDMS-Orthopedics-1-2023
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis Knee; Blood Loss; Arthroplasty Complications

Keywords

total knee arthroplasty; blood loss; tourniquet; complications

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• duration of surgery

  measured once at the time of bandage application after closure

• surgical field clearance

  measured once by the time of closure of incision

• perioperative complications

  assessed within two weeks intervals until 6 months after surgery

Study Arms (2)

limited application

EXPERIMENTAL

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

full-time application

EXPERIMENTAL

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

Interventions

primary unilateral total knee arthroplasty with limited application of tourniquet PROCEDURE

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.

limited application

primary unilateral total knee arthroplasty with full application of tourniquet PROCEDURE

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

full-time application

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients between 50 and 85 years of age with end-stage knee arthritis going primary unilateral TKA after the failure of conservative treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus university

Damascus, Syria

Location

Related Publications (23)

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MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• jaber ibrahim, MD PHD

  Damascus university - faculty of medicine - department of surgery

  STUDY CHAIR

• hakam alasaad, MD

  Damascus university - faculty of medicine - department of surgery

  STUDY DIRECTOR

• doried Diri, MD

  Damascus university - faculty of medicine - department of surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: January 1, 2021
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)