Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jan 28;9(1):e024110.
doi: 10.1136/bmjopen-2018-024110.

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

Zhi-Chao Hu  1   2   3 , Xiao-Bin Li  1   2   3 , Zhen-Hua Feng  1   2   3 , Ji-Qi Wang  1   2   3 , Lan-Fang Gong  4 , Jiang-Wei Xuan  1   2   3 , Xin Fu  1   2   3 , Bing-Jie Jiang  1   2   3 , Long Wu  1   2   3 , Wen-Fei Ni  1   2   3
Affiliations

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

Zhi-Chao Hu et al. BMJ Open. .

Abstract

Introduction: The 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 analysis: A 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 dissemination: The 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 number: NCT03384368; Pre-results.

Keywords: fracture level; modified placement; pedicle screws; thoracolumbar burst fractures.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow chart showing the steps in participant recruitment, treatment and analysis. SD, six pedicle screws are implanted first, and then distraction is performed; DS, four pedicle screws are implanted first, and then distraction is performed, followed by the placement of two pedicle screws at the fracture level.
Figure 2
Figure 2
An example of SD order surgery using X-ray fluoroscopy for thoracolumbar burst fractures. All photographs were collected from the Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University. SD, six pedicle screws are implanted first, and then distraction is performed. SD, screw distraction.
Figure 3
Figure 3
An example of DS order surgery using X-ray fluoroscopy for thoracolumbar burst fractures. All photographs were collected from the Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University. DS, four pedicle screws are implanted first, and then distraction is performed, followed by the placement of two pedicle screws at the fracture level. DS, distraction screw.
See this image and copyright information in PMC

References

    1. Kose KC, Inanmaz ME, Isik C, et al. . Short segment pedicle screw instrumentation with an index level screw and cantilevered hyperlordotic reduction in the treatment of type-A fractures of the thoracolumbar spine. Bone Joint J 2014;96-B:541–7. 10.1302/0301-620X.96B4.33249 - DOI - PubMed
    1. Parker JW, Lane JR, Karaikovic EE, et al. . Successful short-segment instrumentation and fusion for thoracolumbar spine fractures: a consecutive 41/2-year series. Spine 2000;25:1157–70. - PubMed
    1. Modi HN, Chung KJ, Seo IW, et al. . Two levels above and one level below pedicle screw fixation for the treatment of unstable thoracolumbar fracture with partial or intact neurology. J Orthop Surg Res 2009;4:28 10.1186/1749-799X-4-28 - DOI - PMC - PubMed
    1. Alanay A, Acaroglu E, Yazici M, et al. . Short-segment pedicle instrumentation of thoracolumbar burst fractures: does transpedicular intracorporeal grafting prevent early failure? Spine 2001;26:213–7. - PubMed
    1. Cho DY, Lee WY, Sheu PC. Treatment of thoracolumbar burst fractures with polymethyl methacrylate vertebroplasty and short-segment pedicle screw fixation. Neurosurgery 2003;53:1354–61. 10.1227/01.NEU.0000093200.74828.2F - DOI - PubMed

Publication types

Associated data