scholarly journals Modified pedicle screw placement at the fracture level for treatment of thoracolumbar burst fractures: a study protocol of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024110 ◽  
Author(s):  
Zhi-Chao Hu ◽  
Xiao-Bin Li ◽  
Zhen-Hua Feng ◽  
Ji-Qi Wang ◽  
Lan-Fang Gong ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcome ◽  
Pedicle Screw ◽  
Controlled Trial ◽  
Pedicle Screws ◽  
Pedicle Screw Placement ◽  
Thoracolumbar Burst Fractures ◽  
Burst Fractures ◽  
Randomised Controlled ◽  
Fracture Level

IntroductionThe optimal treatment for burst fractures of the thoracolumbar spine is controversial. The addition of screws in the fractured segment has been shown to improve construct stiffness, but can aggravate the trauma to the fractured vertebra. Therefore, optimised placement of two pedicle screws at the fracture level is required for the treatment of thoracolumbar burst fractures. This randomised controlled study is the first to examine the efficacy of diverse orders of pedicle screw placement and will provide recommendations for the treatment of patients with thoracolumbar burst fractures.Methods and analysisA randomised controlled trial with blinding of patients and the statistician, but not the clinicians and researchers, will be conducted. A total of 70 patients with single AO type A3 or A4 thoracolumbar fractures who are candidates for application of short-segment pedicle screws at the fractured vertebral level will be allocated randomly to the distraction-screw and screw-distraction groups at a ratio of 1:1. The primary clinical outcome measures will be the percentage loss of vertebral body height, screw depth in the injured vertebrae and kyphosis (Cobb angle). Secondary clinical outcome measures will be complications, Visual Analogue Scale scores for back and leg pain, neurological function, operation time, intraoperative blood loss, Japanese Orthopaedic Association score and Oswestry Disability Index. These parameters will be evaluated preoperatively, intraoperatively, on postoperative day 3, and at 1, 3, 6, 12 and 24 months postoperatively.Ethics and disseminationThe Institutional Review Board of the Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University have reviewed and approved this study (batch: LCKY2018-05). The results will be presented in peer-reviewed journals and at an international spine-related meeting after completion of the study.Trial registration numberNCT03384368; Pre-results.

scholarly journals Dexamethasone versus prednisone for children receiving asthma treatment in the paediatric inpatient population: protocol for a feasibility randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e025630 ◽  
Author(s):  
Catherine M Pound ◽  
Jaime McDonald ◽  
Ken Tang ◽  
Gillian Seidman ◽  
Radha Jetty ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcome ◽  
Controlled Trial ◽  
Asthma Treatment ◽  
Treatment Regimens ◽  
Asthma Exacerbations ◽  
Feasibility Randomised Controlled Trial ◽  
Short Course ◽  
Inpatient Population ◽  
Randomised Controlled

IntroductionAsthma exacerbations are a leading cause of paediatric hospitalisations. Corticosteroids are key in the treatment of asthma exacerbations. Most current corticosteroids treatment regimens for children admitted with asthma exacerbation consist of a 5-day course of prednisone or prednisolone. However, these medications are associated with poor taste and significant vomiting, resulting in poor compliance with the treatment course. While some centres already use a short course of dexamethasone for treating children hospitalised with asthma, there is no evidence to support this practice in the inpatient population.Methods and analysisThis single-site, pragmatic, feasibility randomised controlled trial will determine the feasibility of a non-inferiority trial, comparing two treatment regimens for children admitted to the hospital and receiving asthma treatment. Children 18 months to 17 years presenting to a Canadian tertiary care centre will be randomised to receive either a short course of dexamethasone or a longer course of prednisone/prednisolone once admitted to the inpatient units. The primary clinical outcome for this feasibility study will be readmission to hospital or repeat emergency department visits, or unplanned visits to primary healthcare providers for asthma symptoms within 4 weeks of hospital discharge. Feasibility outcomes will include recruitment and allocation success, compliance with study procedures, retention rate, and safety and tolerability of study medications. We plan on recruiting 51 children, and between-group comparisons of the clinical outcome will be conducted to gain insights on probable effect sizes.Ethics and disseminationResearch Ethics Board approval has been obtained for this study. The results of this study will inform a multisite trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment, which will have the potential to improve the delivery of asthma care, by improving compliance with a mainstay of treatment. Results will be disseminated through peer-reviewed publications, organisations and meetings.Trial registration numberNCT03133897; Pre-results.

scholarly journals Posterior monoaxial screw fixation combined with distraction-compression technology assisted endplate reduction for thoracolumbar burst fractures: a retrospective study

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Xuhong Xue ◽  
Sheng Zhao
Keyword(s):  
Retrospective Study ◽  
Pedicle Screw ◽  
Screw Fixation ◽  
Pedicle Screws ◽  
Pedicle Screw Fixation ◽  
Thoracolumbar Burst Fractures ◽  
Correction Rate ◽  
Burst Fractures ◽  
The Mean

Abstract Background The management of thoracolumbar burst fractures traditionally involves posterior pedicle screw fixation, but it has some drawbacks. The aim of this study is to evaluate the clinical and radiological outcomes of patients with thoracolumbar burst fractures. They were treated by a modified technique that monoaxial pedicle screws instrumentation and distraction-compression technology assisted end plate reduction. Methods From March 2014 to February 2016, a retrospective study including 42 consecutive patients with thoracolumbar burst fractures was performed. The patients had undergone posterior reduction and instrumentation with monoaxial pedicle screws. The fractured vertebrae were also inserted screws as a push point. The distraction -compression technology was used as assisting end plate reduction. All patients were followed up at a minimum of 2 years. These parameters including segmental kyphosis, severity of fracture, neurological function, canal compromise and back pain were evaluated in preoperatively, postoperatively and at the final follow-up. Results The average follow-up period was 28.9 ± 4.3 months (range, 24-39mo). No patients had postoperative implant failure at recent follow-up. The mean Cobb angle of the kyphosis was improved from 14.2°to 1.1° (correction rate 92.1%). At final follow-up there was 1.5% loss of correction. The mean preoperative wedge angle was improved from 17.1 ± 7.9°to 4.4 ± 3.7°(correction rate 74.3%). The mean anterior and posterior vertebral height also showed significant improvements postoperatively, which were maintained at the final follow-up(P < 0.05). The mean visual analogue scale (VAS) scores was 8 and 1.6 in preoperation and at the last follow-up, and there was significant difference (p < 0.05). Conclusion Based on our experience, distraction-compression technology can assist reduction of collapsed endplate directly. Satisfactory fracture reduction and correction of segmental kyphosis can be achieved and maintained with the use of monoaxial pedicle screw fixation including the fractured vertebra. It may be a good treatment approach for thoracolumbar burst fractures.

Biomechanical Comparison of Different Pedicle Screw Fixations for Thoracolumbar Burst Fractures Using Finite Element Method

2011 ◽  
Vol 117-119 ◽  
pp. 699-702 ◽  
Author(s):  
Dong Mei Wang ◽  
Du Fang Shi ◽  
Xi Lei Li ◽  
Jian Dong ◽  
Chun Hui Wang ◽  
...  
Keyword(s):  
Finite Element Method ◽  
Finite Element ◽  
Pedicle Screw ◽  
Pedicle Screws ◽  
Loading Conditions ◽  
Lateral Bending ◽  
Short Segment ◽  
Thoracolumbar Burst Fractures ◽  
Burst Fractures ◽  
Short Segment Fixation

This study was designed to compare the biomechanical effects of three posterior fixations for thoracolumbar burst fractures using the finite element (FE) method. Five T11-L1 FE models, including the intact, the fractured at T12, the monosegment fixated at the level of the fracture, the short-segment fixated with four pedicle screws and the short-segment fixated with five pedicle screws, were created. And four loading conditions (flexion, extension, lateral bending and torsion) were imposed on these models and deformations in these models under different loading conditions were calculated by finite element method. The biomechanical effects of the three different pedicle screw fixations for thoracolumbar burst fractures were compared and analyzed. The results showed that the displacement level in monosegment fixation model was close to that in the intact one. The extension motion was more limited in short-segment fixation models than that in monosegment fixation model. Under the lateral bending condition, the level of the displacements in these models were similar and the peak rotation angles in the three fixation models were close to that in the intact one. The displacements in fractured T12 were increased in monosegment fixation model under all loading conditions. These indicated that the monosegment fixation couldn’t provide desirable stability for the fractured T11-L1 and the short-segment fixation with five pedicle screws was the best selection because of ideal stability and movability.

scholarly journals Arthroscopic-assisted balloon tibioplasty versus open reduction internal fixation (ORIF) for treatment of Schatzker II–IV tibial plateau fractures: study protocol of a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021667 ◽  
Author(s):  
Ji-Qi Wang ◽  
Bing-Jie Jiang ◽  
Wei-Jun Guo ◽  
Wei-Jiang Zhang ◽  
A-Bing Li ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcome ◽  
Internal Fixation ◽  
Outcome Measures ◽  
Open Reduction ◽  
Tibial Plateau ◽  
Controlled Trial ◽  
Open Reduction Internal Fixation ◽  
Functional Scores ◽  
Randomised Controlled

IntroductionArthroscopic-assisted balloon tibioplasty is an emerging technology that has shown advantages in recovering depression of the articular surface. However, studies evaluating clinical outcomes between arthroscopic-assisted balloon tibioplasty and traditional open reduction internal fixation (ORIF) are sparse. This is the first randomised study to compare arthroscopic-assisted balloon tibioplasty with ORIF, and will provide guidance for treating patients with Schatzker types II, III and IV with depression of the medial tibial plateau only.Methods and analysisA blinded randomised controlled trial will be conducted and a total of 80 participants will be randomly divided into either the arthroscopic-assisted balloon tibioplasty group or the ORIF group, at a ratio of 1:1. The primary clinical outcome measures are the knee functional scores, Rasmussen radiological evaluation scores and the quality of reduction based on postoperative CT scan. Secondary clinical outcome measures are intraoperative blood loss, surgical duration, visual analogue scale score after surgery, hospital duration after surgery, complications and 36-Item Short-Form Health Survey score.Ethics and disseminationThis study has been reviewed and approved by the Institutional Review Board of the Second Affiliated Hospital of Wenzhou Medical University (batch: 2017–12). The results will be presented in peer-reviewed journals after completion of the study.Trial registration numberNCT03327337, Pre-results.

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