Comparison of perioperative hidden blood loss for intertrochanteric fractures in the elderly by different intramedullary fixations: A randomized controlled study protocol

Till date only a few studies have reported the clinical outcomes of intraoperative hidden blood loss of intertrochanteric fracture in the old people treated with various intramedullary immobilizations. The aim of the trial is to investigate the best choice for treating intertrochanteric fractures, a...

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Veröffentlicht in:Medicine (Baltimore) 2020-11, Vol.99 (48), p.e21666-e21666
Hauptverfasser: Zheng, Huayong, Zhang, Yang, Wang, Hao, Sun, Tiansheng, Sun, Qicai
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Zhang, Yang
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Sun, Tiansheng
Sun, Qicai
description Till date only a few studies have reported the clinical outcomes of intraoperative hidden blood loss of intertrochanteric fracture in the old people treated with various intramedullary immobilizations. The aim of the trial is to investigate the best choice for treating intertrochanteric fractures, as well as the hidden blood loss among different intramedullary fixations. This randomized, single-blind, superiority clinical trial was admitted by the Ethics Committee in our hospital (The 7th Medical Center of PLA, 20200602DM). The eligibility criteria were:Patients who met any of the following conditions would not be able to participate in the test: composite femoral fracture, under 65 years of ages, experience of femoral fractures, surgical contraindications, nonambulatory before the presenting injury, or presence of any other traumatic fractures. 120 participants with unstable intertrochanteric fractures, treated by Gammar nail, (n = 40), Proximal Femoral Nail Antirotation (n = 40) and Intertrochanteric Antegrade Nail (n = 40) instruments were enrolled in this research. The main outcome measures were total blood loss and hidden blood loss, which were evaluated based on the haematocrit change after the operation. The experimental data was analyzed and sorted out with SPSS program (ver.19; SPSS Inc., Chicago, IL). This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention. The results of this trial will provide more evidence on which technique can better treat unstable intertrochanteric fracture. This study protocol was registered in Research Registry (researchregistry5788).
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The aim of the trial is to investigate the best choice for treating intertrochanteric fractures, as well as the hidden blood loss among different intramedullary fixations. This randomized, single-blind, superiority clinical trial was admitted by the Ethics Committee in our hospital (The 7th Medical Center of PLA, 20200602DM). The eligibility criteria were:Patients who met any of the following conditions would not be able to participate in the test: composite femoral fracture, under 65 years of ages, experience of femoral fractures, surgical contraindications, nonambulatory before the presenting injury, or presence of any other traumatic fractures. 120 participants with unstable intertrochanteric fractures, treated by Gammar nail, (n = 40), Proximal Femoral Nail Antirotation (n = 40) and Intertrochanteric Antegrade Nail (n = 40) instruments were enrolled in this research. The main outcome measures were total blood loss and hidden blood loss, which were evaluated based on the haematocrit change after the operation. The experimental data was analyzed and sorted out with SPSS program (ver.19; SPSS Inc., Chicago, IL). This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention. The results of this trial will provide more evidence on which technique can better treat unstable intertrochanteric fracture. 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The aim of the trial is to investigate the best choice for treating intertrochanteric fractures, as well as the hidden blood loss among different intramedullary fixations. This randomized, single-blind, superiority clinical trial was admitted by the Ethics Committee in our hospital (The 7th Medical Center of PLA, 20200602DM). The eligibility criteria were:Patients who met any of the following conditions would not be able to participate in the test: composite femoral fracture, under 65 years of ages, experience of femoral fractures, surgical contraindications, nonambulatory before the presenting injury, or presence of any other traumatic fractures. 120 participants with unstable intertrochanteric fractures, treated by Gammar nail, (n = 40), Proximal Femoral Nail Antirotation (n = 40) and Intertrochanteric Antegrade Nail (n = 40) instruments were enrolled in this research. The main outcome measures were total blood loss and hidden blood loss, which were evaluated based on the haematocrit change after the operation. The experimental data was analyzed and sorted out with SPSS program (ver.19; SPSS Inc., Chicago, IL). This experiment had strict inclusive criteria and exclusive criteria and a well- regulated intervention. The results of this trial will provide more evidence on which technique can better treat unstable intertrochanteric fracture. 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subjects Aged
Aged, 80 and over
Blood Loss, Surgical
Bone Nails
Female
Femoral Fractures - surgery
Fracture Fixation, Intramedullary
Health Services for the Aged
Humans
Intraoperative Complications
Male
Middle Aged
Randomized Controlled Trials as Topic
Single-Blind Method
Study Protocol Clinical Trial
title Comparison of perioperative hidden blood loss for intertrochanteric fractures in the elderly by different intramedullary fixations: A randomized controlled study protocol
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