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

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05691751
• Other study ID #: UDMS-Orthopedics-1-2023
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: August 23, 2022

Study information

• Verified date: October 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis Knee
• Arthroplasty Complications
• Blood Loss
• Hemorrhage

Intervention

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.
• 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

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus university	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (23)

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Ahmed I, Chawla A, Underwood M, Price AJ, Metcalfe A, Hutchinson CE, Warwick J, Seers K, Parsons H, Wall PDH. Time to reconsider the routine use of tourniquets in total knee arthroplasty surgery. Bone Joint J. 2021 May;103-B(5):830-839. doi: 10.1302/0301-620X.103B.BJJ-2020-1926.R1. Epub 2021 Mar 8. — View Citation

Cao Z, Guo J, Li Q, Wu J, Li Y. Comparison of efficacy and safety of different tourniquet applications in total knee arthroplasty: a network meta-analysis of randomized controlled trials. Ann Med. 2021 Dec;53(1):1816-1826. doi: 10.1080/07853890.2021.1991588. — View Citation

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Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014 Aug;85(4):422-6. doi: 10.3109/17453674.2014.931197. Epub 2014 Jun 23. — View Citation

Everhart JS, Sojka JH, Mayerson JL, Glassman AH, Scharschmidt TJ. Perioperative Allogeneic Red Blood-Cell Transfusion Associated with Surgical Site Infection After Total Hip and Knee Arthroplasty. J Bone Joint Surg Am. 2018 Feb 21;100(4):288-294. doi: 10.2106/JBJS.17.00237. — View Citation

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Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041. — View Citation

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Horlocker TT, Hebl JR, Gali B, Jankowski CJ, Burkle CM, Berry DJ, Zepeda FA, Stevens SR, Schroeder DR. Anesthetic, patient, and surgical risk factors for neurologic complications after prolonged total tourniquet time during total knee arthroplasty. Anesth Analg. 2006 Mar;102(3):950-5. doi: 10.1213/01.ane.0000194875.05587.7e. — View Citation

Kim C, Park SS, Davey JR. Tranexamic acid for the prevention and management of orthopedic surgical hemorrhage: current evidence. J Blood Med. 2015 Aug 25;6:239-44. doi: 10.2147/JBM.S61915. eCollection 2015. — View Citation

Lu Q, Peng H, Zhou GJ, Yin D. Perioperative Blood Management Strategies for Total Knee Arthroplasty. Orthop Surg. 2018 Feb;10(1):8-16. doi: 10.1111/os.12361. Epub 2018 Feb 9. — View Citation

Park JH, Restrepo C, Norton R, Mandel S, Sharkey PF, Parvizi J. Common peroneal nerve palsy following total knee arthroplasty: prognostic factors and course of recovery. J Arthroplasty. 2013 Oct;28(9):1538-42. doi: 10.1016/j.arth.2013.02.025. Epub 2013 Apr 4. — View Citation

Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, Ritter MA, Nunley RM. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty. 2013 Sep;28(8 Suppl):116-9. doi: 10.1016/j.arth.2013.04.056. Epub 2013 Aug 15. — View Citation

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Singh JA. Epidemiology of knee and hip arthroplasty: a systematic review. Open Orthop J. 2011 Mar 16;5:80-5. doi: 10.2174/1874325001105010080. — View Citation

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Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15. — View Citation

Vaishya R, Chauhan M, Vaish A. Bone cement. J Clin Orthop Trauma. 2013 Dec;4(4):157-63. doi: 10.1016/j.jcot.2013.11.005. Epub 2013 Dec 15. — View Citation

Wang C, Zhou C, Qu H, Yan S, Pan Z. Comparison of tourniquet application only during cementation and long-duration tourniquet application in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2018 Aug 30;13(1):216. doi: 10.1186/s13018-018-0927-6. — View Citation

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Xu H, Yang J, Xie J, Huang Z, Huang Q, Cao G, Pei F. Tourniquet use in routine primary total knee arthroplasty is associated with a higher transfusion rate and longer postoperative length of stay: a real-world study. BMC Musculoskelet Disord. 2020 Sep 18;21(1):620. doi: 10.1186/s12891-020-03623-5. — View Citation

Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Mar 6;9(1):13. doi: 10.1186/1749-799X-9-13. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	surgical field clearance	surgical field clearance as evaluated by the surgeon	measured once by the time of closure of incision
Secondary	perioperative complications	like the incidence of infection, VTE, etc	assessed within two weeks intervals until 6 months after surgery