Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial
Purpose: This study aims to evaluate the effectiveness and safety of Aspirin and LMWH in an arthroscopic anterior cruciate ligament (ACL) reconstruction of low-risk patients. Material and Methods: We conduct a single-center, assessor-blind, simple randomized clinical trial from March 2019- May...
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| Format: | Article |
| Language: | English |
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Tehran University of Medical Sciences
2024-10-01
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| Series: | Journal of Orthopedic and Spine Trauma |
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| Online Access: | https://jost.tums.ac.ir/index.php/jost/article/view/506 |
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| author | Mohammadreza Minator Sajjadi Mohammad Nazarinasab Amirali Behroozi Amin Karimi Amir Mehrvar Seyed Amir Ahmad Safavi Naini |
| author_facet | Mohammadreza Minator Sajjadi Mohammad Nazarinasab Amirali Behroozi Amin Karimi Amir Mehrvar Seyed Amir Ahmad Safavi Naini |
| author_sort | Mohammadreza Minator Sajjadi |
| collection | DOAJ |
| description |
Purpose: This study aims to evaluate the effectiveness and safety of Aspirin and LMWH in an arthroscopic anterior cruciate ligament (ACL) reconstruction of low-risk patients.
Material and Methods: We conduct a single-center, assessor-blind, simple randomized clinical trial from March 2019- May 2020. 18 to 45 years old patients with ACL rupture without concomitant injury, diagnosed by magnetic resonance imaging, enrolled in the study. Selected subjects were allocated between three parallel arms of the study, with 46 participants.
Three parallels are 8o mg aspirin bid for 14 days, LMWH subcutaneous injection for 14 days, and no treatment parallel. Effectiveness outcomes were estimated by the DVT rate and PE rate, and safety was checked out by bleeding or hemarthrosis. Orthopedists assessed knee effusion with stroke score and ask patients for any symptoms during weekly clinic visits. The radiologist performed ultrasonography of lower extremities, searching for a sign of DVT.
Results: Mean age of participants was 31.4 + 5.6, and 93 individuals (67%) were male and 23% were female. No DVT and PE were observed. Three cases in the LMWH and one case in aspirin groups had minor surgical site bleeding. One case of hemarthrosis with normal ultrasonography occurred in the LMWH group. Regarding safety and effectiveness, there was no statistically significant difference between the parallels.
Conclusion: Use of LMWH or Aspirin after simple arthroscopic ACL reconstruction in low-risk patients have no different effectiveness. Hence routine use of thromboprophylaxis in this setting is questionable, although adverse events are rare.
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| format | Article |
| id | doaj-art-a0f056950a274c579381b565d6eab5d6 |
| institution | Kabale University |
| issn | 2538-2330 2538-4600 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Tehran University of Medical Sciences |
| record_format | Article |
| series | Journal of Orthopedic and Spine Trauma |
| spelling | doaj-art-a0f056950a274c579381b565d6eab5d62024-11-12T06:45:12ZengTehran University of Medical SciencesJournal of Orthopedic and Spine Trauma2538-23302538-46002024-10-0110310.18502/jost.v10i3.16779Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical TrialMohammadreza Minator Sajjadi0Mohammad Nazarinasab1Amirali Behroozi2Amin Karimi3Amir Mehrvar4Seyed Amir Ahmad Safavi Naini51- Associate Professor, Department of Orthopedics, Taleghani Hospital Research Development Committee, Shahid Beheshti University of Medical Sciences, Tehran, IranShahid Beheshti University of Medical Sciences, Tehran, Iran.Orthopedic Surgeon, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.Assistant professor of Department of Orthopedics, Taleghani Hospital Research Development committee, Medical school, Shahid Beheshti University of medical sciences, Tehran, Iran.Assistant professor of Department of Orthopedics, Taleghani Hospital Research Development committee, Medical school, Shahid Beheshti University of medical sciences, Tehran, Iran.Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Purpose: This study aims to evaluate the effectiveness and safety of Aspirin and LMWH in an arthroscopic anterior cruciate ligament (ACL) reconstruction of low-risk patients. Material and Methods: We conduct a single-center, assessor-blind, simple randomized clinical trial from March 2019- May 2020. 18 to 45 years old patients with ACL rupture without concomitant injury, diagnosed by magnetic resonance imaging, enrolled in the study. Selected subjects were allocated between three parallel arms of the study, with 46 participants. Three parallels are 8o mg aspirin bid for 14 days, LMWH subcutaneous injection for 14 days, and no treatment parallel. Effectiveness outcomes were estimated by the DVT rate and PE rate, and safety was checked out by bleeding or hemarthrosis. Orthopedists assessed knee effusion with stroke score and ask patients for any symptoms during weekly clinic visits. The radiologist performed ultrasonography of lower extremities, searching for a sign of DVT. Results: Mean age of participants was 31.4 + 5.6, and 93 individuals (67%) were male and 23% were female. No DVT and PE were observed. Three cases in the LMWH and one case in aspirin groups had minor surgical site bleeding. One case of hemarthrosis with normal ultrasonography occurred in the LMWH group. Regarding safety and effectiveness, there was no statistically significant difference between the parallels. Conclusion: Use of LMWH or Aspirin after simple arthroscopic ACL reconstruction in low-risk patients have no different effectiveness. Hence routine use of thromboprophylaxis in this setting is questionable, although adverse events are rare. https://jost.tums.ac.ir/index.php/jost/article/view/506Venous thromboembolism; Arthroplasty; Randomized Controlled Trial; HeparinLow-Molecular-Weight; Aspirin |
| spellingShingle | Mohammadreza Minator Sajjadi Mohammad Nazarinasab Amirali Behroozi Amin Karimi Amir Mehrvar Seyed Amir Ahmad Safavi Naini Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial Journal of Orthopedic and Spine Trauma Venous thromboembolism; Arthroplasty; Randomized Controlled Trial; Heparin Low-Molecular-Weight; Aspirin |
| title | Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial |
| title_full | Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial |
| title_fullStr | Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial |
| title_full_unstemmed | Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial |
| title_short | Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Underwent Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial |
| title_sort | pharmacological thromboprophylaxis effectiveness in low risk patients underwent arthroscopic anterior cruciate ligament reconstruction a randomized clinical trial |
| topic | Venous thromboembolism; Arthroplasty; Randomized Controlled Trial; Heparin Low-Molecular-Weight; Aspirin |
| url | https://jost.tums.ac.ir/index.php/jost/article/view/506 |
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