Dataset Information

Is postoperative bracing after pedicle screw fixation of spine fractures necessary? Study protocol of the ORNOT study: a randomised controlled multicentre trial.

ABSTRACT:

Introduction

The most common surgical treatment of traumatic spine fractures is through a posterior approach using pedicle screws and rods. Postoperative treatment protocols including the use of postoperative orthoses however differ between hospitals and surgeons. A three-point hyperextension orthosis is designed to support proper posture and unload the anterior column. Some motion remains when wearing an orthosis, and its main value in postoperative treatment is therefore believed to be pain relief and patient confidence. This could consequently shorten recovery time. On the other hand, an orthosis could also lead to muscle weakness and slow down recovery. Any orthosis-related complications might also be avoided. Additionally, recent studies on conservative fracture treatment show no difference in radiological outcomes with or without an orthosis. To date, no randomised studies have been performed on the use of postoperative orthoses.

Methods and analysis

Patients undergoing posterior fixation with pedicle screws for a traumatic thoracolumbar fracture (T7-L4) will be included in this randomised controlled multicentre non-inferiority trial. Forty-six patients will be randomised 1:1 to one of the two parallel groups; one group will wear a postoperative orthosis for 6 weeks followed by 6 weeks of weaning and one group will not wear an orthosis. The primary outcome is pain at 6 weeks reported on the Numerical Rating Scale. Secondary outcomes consist of pain on other moments, analgesic use, complications and length of hospital stay, quality of life (EuroQuol 5 Dimensions), back pain-related function (Oswestry Disability Index) and radiological outcomes with a follow-up of 1 year. Orthosis compliance is monitored weekly in the orthosis group.

Ethics and dissemination

The institutional review board (METc VUmc) approved this study on 11 October 2016 under case number 2016.389. After completion of the trial, the results will be offered to an international scientific journal for peer-reviewed publication.

Trial registration number

NCT03097081 and NTR6285; Pre-results.

SUBMITTER: Smits AJ

PROVIDER: S-EPMC5781062 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Publications

Is postoperative bracing after pedicle screw fixation of spine fractures necessary? Study protocol of the ORNOT study: a randomised controlled multicentre trial.

Smits Arjen Johannes AJ Deunk Jaap J Stadhouder Agnita A Altena Mark Cornelis MC Kempen Diederik Hendrik Ruth DHR Bloemers Frank Willem FW

BMJ open 20180113 1

<h4>Introduction</h4>The most common surgical treatment of traumatic spine fractures is through a posterior approach using pedicle screws and rods. Postoperative treatment protocols including the use of postoperative orthoses however differ between hospitals and surgeons. A three-point hyperextension orthosis is designed to support proper posture and unload the anterior column. Some motion remains when wearing an orthosis, and its main value in postoperative treatment is therefore believed to be ...[more]

PMID: 29331975

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Project description:BackgroundThe anterior pedicle screw (APS) technique for L5 and S1 is crucial for proper anterior lumbar interbody fusion (ALIF). This study aimed to determine the projection, screw trajectory angle, and bone screw passageway length (BSPL), as well as the screw insertion regularity and the operating area within which it is safe to perform insertion.MethodsForty patients with low back pain, all of whom had lumbar computed tomography scans available, was included in this retrospective analysis. Radiographic parameters were measured, including: the distances from the projection to the upper endplate, lower endplate, and midline; the transverse and sagittal screw angles; and the BSPL. In addition, 10 fresh adult cadaveric lumbosacral spine segments were selected to determine the safe anatomic area in which to operate. Finally, APSs were inserted in L5 and S1 to determine the regularity of APS insertion.ResultsWe measured the anterior projection parameters, including: the distances to the upper endplate (L5: 12.5±1.3 mm; S1: 4.54±0.87 mm), lower endplate (L5: 17.3±1.6 mm), and midline (L5: 6.6±0.7 mm; S1: 6.6±0.6 mm); the screw trajectory angle, including the transverse screw angle (L5: 25.3±2.8°; S1: 25.7±2.6°), sagittal screw angle (L5: 17.1±1.7°; S1: 22.4±1.1°); and the BSPL (L5: 48.6±3.5 mm; S1: 48.0±3.5 mm). The regularity of APS insertion in L5 and S1 was determined. Upon the needle reaching a point in the lateral view, it reached the corresponding point in the anteroposterior (AP) view. The anatomic parameters of the safe operating area were as follows: the distance from the abdominal aortic bifurcation to the L5 lower edge (40.50±9.40 mm); the distance from the common iliac vein confluence to the L5 lower edge (27.80±8.60 mm); and the horizontal distance from the inner edge of the common iliac vein to the L5 lower edge (37.50±1.30 mm). We also determined the distance between S1 holes (29.30±1.30 mm), the L5/S1 intervertebral height (17.20±1.50 mm), and the safe operating area (2,058.20±84.30 mm2).ConclusionsThis study has determined the projection, screw trajectory angle, and BSPL of APSs in L5 and S1, their insertion regularity, and the area in which the operation can be safely performed.

Project description:PurposePedicle screw fixation in the upper cervical spine is a difficult and high-risk procedure. The screw is difficult to place rapidly and accurately, and can lead to serious injury of spinal cord or vertebral artery. The aim of this study was to design an individualized 3D printing navigation template for pedicle screw fixation in the upper cervical spine.MethodsUsing CT thin slices data, we employed computer software to design the navigation template for pedicle screw fixation in the upper cervical spine (atlas and axis). The upper cervical spine models and navigation templates were produced by 3D printer with equal proportion, two sets for each case. In one set (Test group), pedicle screws fixation were guided by the navigation template; in the second set (Control group), the screws were fixed under fluoroscopy. According to the degree of pedicle cortex perforation and whether the screw needed to be refitted, the fixation effects were divided into 3 types: Type I, screw is fully located within the vertebral pedicle; Type II, degree of pedicle cortex perforation is <1 mm, but with good internal fixation stability and no need to renovate; Type III, degree of pedicle cortex perforation is >1 mm or with the poor internal fixation stability and in need of renovation. Type I and Type II were acceptable placements; Type III placements were unacceptable.ResultsA total of 19 upper cervical spine and 19 navigation templates were printed, and 37 pedicle screws were fixed in each group. Type I screw-placements in the test group totaled 32; Type II totaled 3; and Type III totaled 2; with an acceptable rate of 94.60%. Type I screw placements in the control group totaled 23; Type II totaled 3; and Type III totaled 11, with an acceptable rate of 70.27%. The acceptability rate in test group was higher than the rate in control group. The operation time and fluoroscopic frequency for each screw were decreased, compared with control group.ConclusionThe individualized 3D printing navigation template for pedicle screw fixation is easy and safe, with a high success rate in the upper cervical spine surgery.

Project description:ObjectiveThe purpose of this study was to analyse the biomechanical characteristics of pedicle screws with different placement methods and diameters in the treatment of Tile C1 pelvic fractures by finite element simulation technology and to compare them with the plate fixation model to verify the effectiveness of pedicle screw fixation.MethodsA three-dimensional digital model of a normal pelvis was obtained using computed tomography images. A finite element model of a normal pelvis containing major ligaments was built and validated (Model 1). Based on the verified normal pelvis finite element model, a Tile C1 pelvic fracture model was established (Model 2), and then a plate fixation model (Model 3) and a pedicle screw fixation model with different screw placement methods and diameters were established (Models 4-15). For all pelvic fracture fixation models, a vertical load of 500 N was applied on the upper surface of the sacrum to test the displacement and stress distribution of the pelvis in the standing state with both legs.ResultsThe finite element simulation results showed the maximum displacement of Model 1 and Models 3-15 to be less than 1 mm. The overall maximum displacement of Models 4-15 was slightly larger than that of Model 3 (the maximum difference was 177.91×10-3 mm), but the maximum displacement of iliac bone and internal fixation in Models 4-15 was smaller than that of Model 3. The overall maximum stress (maximum stress of the ilium) and maximum stress of internal fixation in Models 4-15 were less than those in Model 3. The maximum displacement difference and maximum stress difference at the fracture of the pubic ramus between each fixed model were less than 0.01 mm and 1 MPa, respectively. The greater the diameter and number of pedicle screws were, the smaller the maximum displacement and stress of the pelvic fracture models were.The maximum displacement and stress of the pelvic fracture models of the screws placed on the injured side of the pubic region were smaller than the screws on the healthy side.ConclusionBoth the anterior and posterior pelvic rings are fixed with a pedicle screw rod system for treatment of Tile C1 pelvic fractures, which can obtain sufficient biomechanical stability and can be used as a suitable alternative to other implants.The greater the diameter and number of pedicle screws were, the greater the pelvic stability was, and the greater was the stability of the screws placed on the injured side of the pubic region than the screws on the healthy side.

Project description:BackgroundThere is limited data available on the use of orthoses across varying elective spine surgeries. When previously studied in 2009, inconsistent lumbar postoperative bracing practices were reported. The present study aimed to provide a ten-year update regarding postoperative bracing practices after elective lumbar surgery among United States (U.S.) spine surgeons.MethodsA questionnaire was distributed to attendees of the Lumbar Spine Research Society Annual Meeting (April 2019). The questionnaire collected demographic information, and asked surgeons to identify if they used orthoses postoperatively after ten elective lumbar surgeries. Information regarding type of brace, duration of use, and reason for bracing was also collected. Chi-square tests and one-way analysis of variance (ANOVA) were used for comparisons.ResultsSeventy-three of 88 U.S. attending surgeons completed the questionnaire (response rate: 83%). The majority of respondents were orthopaedic surgery-trained (78%), fellowship-trained (84%), and academic surgeons (73%). The majority of respondents (60%) did not use orthoses after any lumbar surgery. Among the surgeons who braced, the overall bracing frequency was 26%. This rate was significantly lower than that reported in the literature ten years earlier (p<0.0001). Respondents tended to use orthoses most often after stand-alone lateral interbody fusions (43%) (p<0.0001). The average bracing frequency after lumbar fusions (34%) was higher than the average bracing frequency after non-fusion surgeries (16%) (p<0.0001). The most frequently utilized brace was an off the shelf lumbar sacral orthosis (66%), and most surgeons braced patients to improve pain (42%). Of surgeons who braced, most commonly did so for 2-4 months (57%).ConclusionMost surgeon respondents did not prescribe orthoses after varying elective lumbar surgeries, and the frequency overall was lower than a similar study conducted in 2009. There continues to be inconsistencies in postoperative bracing practices. In an era striving for evidence-based practices, this is an area needing more attention.

Dataset Information

Is postoperative bracing after pedicle screw fixation of spine fractures necessary? Study protocol of the ORNOT study: a randomised controlled multicentre trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Is postoperative bracing after pedicle screw fixation of spine fractures necessary? Study protocol of the ORNOT study: a randomised controlled multicentre trial.

Similar Datasets

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