Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA
NCT ID: NCT05691751
Last Updated: 2023-10-24
Study Results
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Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2021-01-01
2022-08-23
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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limited application
Will go primary unilateral TKA with the tourniquet inflated only during cementation and final components of the prosthesis application
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.
full-time application
will go unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
50 Years
85 Years
ALL
Yes
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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jaber ibrahim, MD PHD
Role: STUDY_CHAIR
Damascus university - faculty of medicine - department of surgery
hakam alasaad, MD
Role: STUDY_DIRECTOR
Damascus university - faculty of medicine - department of surgery
doried Diri, MD
Role: PRINCIPAL_INVESTIGATOR
Damascus university - faculty of medicine - department of surgery
Locations
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Damascus university
Damascus, , Syria
Countries
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References
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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.
Whittaker JL, Truong LK, Dhiman K, Beck C. Osteoarthritis year in review 2020: rehabilitation and outcomes. Osteoarthritis Cartilage. 2021 Feb;29(2):190-207. doi: 10.1016/j.joca.2020.10.005. Epub 2020 Nov 24.
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.
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.
Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
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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.
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.
Sundaram K, Udo-Inyang I, Mont MA, Molloy R, Higuera-Rueda C, Piuzzi NS. Vascular Injuries in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2020 Jan;8(1):e0051. doi: 10.2106/JBJS.RVW.19.00051.
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.
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.
Sehat KR, Evans RL, Newman JH. Hidden blood loss following hip and knee arthroplasty. Correct management of blood loss should take hidden loss into account. J Bone Joint Surg Br. 2004 May;86(4):561-5.
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.
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.
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.
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.
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.
Ferraris VA, Hochstetler M, Martin JT, Mahan A, Saha SP. Blood transfusion and adverse surgical outcomes: The good and the bad. Surgery. 2015 Sep;158(3):608-17. doi: 10.1016/j.surg.2015.02.027. Epub 2015 May 29.
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.
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Other Identifiers
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UDMS-Orthopedics-1-2023
Identifier Type: -
Identifier Source: org_study_id
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