Study Results
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Basic Information
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COMPLETED
NA
192 participants
INTERVENTIONAL
2021-08-06
2025-04-01
Brief Summary
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The primary outcomes will be total blood loss and transfusion requirements. Secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion. The study will help clarify whether suction drainage is necessary when intra-articular TNA is used during TKA.
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Detailed Description
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This single-center, prospective randomized study will enroll 192 patients undergoing unilateral TKA for degenerative arthritis. Participants will be assigned to three groups: (1) TNA with suction drainage, (2) TNA only, and (3) suction drainage only. TNA will be administered intra-articularly at a dose of 3 g in 100 mL normal saline after wound closure. When applied, suction drains will be activated two hours postoperatively.
The primary outcomes will be total blood loss and transfusion requirement. The secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion at two months. Statistical analysis will be conducted using ANOVA, repeated-measures t-tests, and chi-square tests, with significance set at p ≤ 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tranexamic Acid with Suction Drainage
Patients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. A closed suction drain was inserted intra-articularly and subcutaneously, activated two hours postoperatively.
Intra-articular Tranexamic Acid + Suction Drainage
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure, along with a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively.
Tranexamic Acid without Drainage
Patients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. No suction drain was used in this group.
Intra-articular Tranexamic Acid
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure. No suction drain was used.
Suction Drainage without Tranexamic Acid
Patients undergoing total knee arthroplasty had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered in this group.
Suction Drainage Only
Patients had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered.
Interventions
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Intra-articular Tranexamic Acid + Suction Drainage
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure, along with a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively.
Intra-articular Tranexamic Acid
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure. No suction drain was used.
Suction Drainage Only
Patients had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered.
Eligibility Criteria
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Inclusion Criteria
* Scheduled for unilateral total knee arthroplasty
Exclusion Criteria
* Cardiovascular diseases (e.g., angina, myocardial infarction, arrhythmia, cerebrovascular events)
* Coagulation disorders or thromboembolic disorders
* Severe infections
* Other serious health issues
50 Years
90 Years
ALL
No
Sponsors
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Idlib University
OTHER
Responsible Party
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Mhmoud Adnan Al salamah
Principal Investigator, Department of Orthopedic Surgery, Idlib University
Principal Investigators
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Mhmoud Adnan Al-Salamah
Role: PRINCIPAL_INVESTIGATOR
Idlib University
Locations
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Faculity of Medicine
Idlib, , Syria
Countries
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References
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Hishimura R, Onodera T, Ohkoshi Y, Okada K, Matsuoka M, Matsubara S, Iwasaki K, Kondo E, Iwasaki N. The effect of local injection of tranexamic acid into peri-articular tissue versus drain clamping in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Feb 2;23(1):111. doi: 10.1186/s12891-022-05058-6.
Kim MK, Ko SH, Nam YC, Jeon YS, Kwon DG, Ryu DJ. Optimal Release Timing of Drain Clamping to Reduce Postoperative Bleeding after Total Knee Arthroplasty with Intraarticular Injection of Tranexamic Acid. Medicina (Kaunas). 2022 Sep 5;58(9):1226. doi: 10.3390/medicina58091226.
Liu CH, Chang CH, Chang YH, Shih HN, Hu CC. Topical Fibrin Sealant (Tisseel@) Does Not Provide a Synergic Blood-Conservation Effect with Tranexamic Acid in Total Knee Arthroplasty-A Prospective Randomized Controlled Trial. Medicina (Kaunas). 2023 Nov 26;59(12):2078. doi: 10.3390/medicina59122078.
Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of hypotensive anesthesia and regional anesthesia on intraoperative blood loss in total knee arthroplasty. World J Emerg Surg. 2024;19(1):33. doi:10.1186/s13017-024-00554-7
Chaiyakit P, Kabkaew P, Hongku N, Wattanapreechanon P. Comparison of total blood loss between limited tourniquet use and conventional tourniquet use in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Nov 15;25(1):918. doi: 10.1186/s12891-024-08058-w.
Zhou C, Gao X, Han H, Wang L, Jiang H. The efficacy and safety of tranexamic acid in primary total knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2024;19(1):37. doi:10.1177/15563316231208716.
Liu Y, Ai J, Teng X, Huang Z, Wu H, Zhang Z, Wang W, Liu C, Zhang H. Risk factor analysis and establishment of a nomogram model to predict blood loss during total knee arthroplasty. BMC Musculoskelet Disord. 2024 Jun 10;25(1):459. doi: 10.1186/s12891-024-07570-3.
Gonzalez-Pola R, Tafoya-Olivos RO, Culebras-Almeida LA, Zermeño-Garcia G, Herrera-Lozano A. Minimizing bleeding and transfusion in single-stage bilateral hip and knee arthroplasty: a systematic review of current interventions. Rev Esp Cir Ortop Traumatol (Engl Ed). 2025;69(2):e58. doi:10.1016/j.recot.2025.02.002.
Ju Y, Liu H, Jiang W, Huang Q, Zhou Z, Pei F. Perioperative blood loss of sequential administration of hemocoagulase Agkistrodon and Tranexamic acid for primary total knee arthroplasty: a randomized controlled trial. J Orthop Surg Res. 2025 May 13;20(1):457. doi: 10.1186/s13018-025-05867-0.
Liangliang L, Wei H, Tao Z, Pin P, Lianying H. Efficacy and safety of tranexamic acid in reducing hidden blood loss during unilateral total knee arthroplasty: a retrospective study. Front Med (Lausanne). 2025 Jun 3;12:1552893. doi: 10.3389/fmed.2025.1552893. eCollection 2025.
Other Identifiers
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NW-Syria-TKA-Study-01
Identifier Type: OTHER
Identifier Source: secondary_id
T.A in Knee Arthroplasty
Identifier Type: -
Identifier Source: org_study_id
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