fixation with or without screwing of the fractured

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Page 1/15 Comparative Study of Clinical Ecacy of Percutaneous Short Segment Pedicle Screw Fixation With or Without Screwing of the Fractured Vertebra With O-arm Navigation Xiaofeng Shao The First Aliated Hospital of Soochow University Peng Peng The rst aliated hospital of soochow university Peng Yang The First Aliated Hospital of soochow university Tian Xu the rst aliated hospital of soochow university Zixiang Liu The First Aliated Hospital of soochow university Xi Hua the rst aliated hospital of soochow university Xiaoyu Zhu the rst aliated hospital of soochow university Zhonglai Qian the rst aliated hospital of soochow university Huilin Yang the rst aliated of soochow university Haiqing Mao the rst aliated hospital of soochow university Chen Kangwu ( [email protected] ) The First Aliated Hospital of Soochow University Research article Keywords: O-arm, thoracolumbar fractures, injured vertebrae, fracture xation, percutaneous pedicle screws Posted Date: January 29th, 2021

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Comparative Study of Clinical E�cacy ofPercutaneous Short Segment Pedicle ScrewFixation With or Without Screwing of the FracturedVertebra With O-arm NavigationXiaofeng Shao 

The First A�liated Hospital of Soochow UniversityPeng Peng 

The �rst a�liated hospital of soochow universityPeng Yang 

The First A�liated Hospital of soochow universityTian Xu 

the �rst a�liated hospital of soochow universityZixiang Liu 

The First A�liated Hospital of soochow universityXi Hua 

the �rst a�liated hospital of soochow universityXiaoyu Zhu 

the �rst a�liated hospital of soochow universityZhonglai Qian 

the �rst a�liated hospital of soochow universityHuilin Yang 

the �rst a�liated of soochow universityHaiqing Mao 

the �rst a�liated hospital of soochow universityChen Kangwu  ( [email protected] )

The First A�liated Hospital of Soochow University

Research article

Keywords: O-arm, thoracolumbar fractures, injured vertebrae, fracture �xation, percutaneous pediclescrews

Posted Date: January 29th, 2021

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DOI: https://doi.org/10.21203/rs.3.rs-157728/v1

License: This work is licensed under a Creative Commons Attribution 4.0 International License.  Read Full License

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AbstractObjective: To retrospectively analyze the short-term and long-term e�cacy of O-arm-navigatedpercutaneous short segment pedicle screw �xation with or without screwing of the fractured vertebra.

Methods: 42 patients who underwent O-arm-navigated percutaneous short segment pedicle screw�xation for the treatment of thoracolumbar fractures from February 2015 to December 2018 wereselected. The patients were divided into two groups according to �xation with or without screwing of thefractured vertebra, 21 cases each. The operation time, length of incision and intraoperative bleeding ofthe two groups of patients, as well as preoperative, one-week postoperatively and one-yearpostoperatively Cobb angle, percentage of anterior vertebral height, VAS and ODI data were analyzed tocompare the short-term and long-term clinical outcomes of the two groups.

Results: All the patients underwent surgery successfully. There were no neurological or othercomplications after the surgery. All patients were followed up for at least one year. There was no failureof �xation at the one-year follow-up. There was no signi�cant difference in the operation time andintraoperative blood loss between the two groups (P>0.05). The length of incision was statisticallysigni�cantly different between the two groups (P<0.05). There was no signi�cant difference in Cobbangle and AVH% between the two groups before and one week after the surgery (P>0.05). The Cobb angleand AVH% was statistically signi�cantly different one year after the surgery between the two groups(P<0.05).The Cobb angle and AVH% contrast was statistically signi�cant before surgery, one week andone year after the surgery in the respective group (P<0.05). There was no statistically signi�cantdifference in the VAS and ODI preoperatively, one-week and one-year postoperatively between the twogroups (P>0.05). There was statistically signi�cant difference in the VAS and ODI throughout the follow-up period in the respective group(P<0.05).

Conclusion: The short-term e�cacy of the two groups is similar, but the long-term e�cacy is betterthrough screwing of the fractured vertebra.

IntroductionWith the rapid development of industry and the extensive popularization of high-speed vehicles, theoccurrence frequency of thoracolumbar fracture has been greatly increased. People suffered from thisfracture may need large medical costs and long-time recovery, which will increase the social burden.Thoracolumbar fractures have been reported to be more common in men, with a male-to-female ratio ofabout 2:1 and a peak incidence between the age of 20 and 40[1].

The thoracolumbar segment (T11-L2) is a transitional region between the relatively low-motion thoracicvertebra and the relatively high-motion lumbar vertebra, where 50–70% of thoracolumbar fracturesoccurred[2]. Thoracolumbar fractures leading to spinal instability and nerve damage often require surgeryto get su�cient decompression, vertebral height restoration and stability, avoiding kyphosis and nervedamage and promoting early recovery. At the present, the surgical treatment of thoracolumbar fracture is

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still controversial. In terms of the choice of approach, there are front approach, posterior approach andfront-posterior approach. In the �xation number of segments, long segments or short segments can bechosen. In the injured vertebra, screw placement or no screw placement can be adopted. In addition, newminimally invasive techniques, such as percutaneous screw placement and kyphoplasty, have providednovel idea for the treatment of thoracolumbar fracture [3–5].

Compared with traditional posterior open surgery, the minimally invasive percutaneous pedicle screwplacement technique has the characteristics of smaller incision, less bleeding, less dissection ofparaspinal muscle tissue, less pain and faster postoperative recovery[6, 7]. In recent years, theappearance of navigation equipment such as O-arm machine has reduced surgical trauma, shortened theoperation time and improved the accuracy of surgery[8, 9].

This retrospective study analyzed the clinical and imaging data of patients received O-arm assistedminimally invasive percutaneous pedicle screw insertion for thoracolumbar fractures (T11-L2) in ourhospital from February 2015 to December 2018, to observe the short-term and long-term e�cacy of thetwo surgical methods and to compare the differences.

Materials And Methods

Clinical data42 patients suffered from single segmental thoracolumbar fractures (T11-L2) without neurologicaldamage in our hospital were involved in this retrospective study. 21 of them accepted the O-arm guidedpercutaneous minimally invasive short segmental pedicle screw �xation with screwing of the fracturedvertebra treatment (fractured vertebra screwing group) and the rest of the paticipants accepted the O-armguided percutaneous minimally invasive short segmental pedicle screw �xation without screwing of thefractured vertebra treatment (no fractured vertebra screwing group). We drew up inclusion criteria asfollows: (1) Patients had a de�nite history of single-segment thoracolumbar fracture; (2) No neurologicalsymptoms; (3) Intact vertebral pedicle of the injured vertebra and its adjacent upper and lower vertebralbodies; (4) MRI (magnatic resonance imaging) indicated new fractures and no compression of the spinalcord; (5) No signi�cant displacement or dislocation of the fracture. The exclusion standards were: (1)Patients had previous spinal surgeries or old fracture; (2) Patients had severe head trauma or internalorgan injury and severe medical disease; (3) Pathological fractures (tumors, tuberculosis, etc.), metabolicbone disease and osteoporosis; (4) Congenital dysplasia of the pedicle, incomplete pedicle of the injuredvertebra or its adjacent upper and lower vertebral bodies; (5) There are obvious symptoms of nerve injurythat need spinal canal decompression. Except the different surgery methods, patients received the sametreatment preoperatively, intraoperatively and postoperatively.

Surgical Techniques

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Percutaneous short segment pedicle screw �xation withscrewing of the fractured vertebra with O-arm navigationAfter successful general anesthesia, the patient was placed in prone position on the Jackson carbon �bersurgical bed, the shoulders and buttocks were secured. A longitudinal incision about 2.5 cm was made toexpose the spinous process of the adjacent segment along posterior median line, and the reference�xture was �xed on the spinous process. Then the �rst scan of the O-arm was performed to obtain theintraoperative 3D images and transmit the image data to the Stealth Station navigation system, wherehigh-resolution images in the axial, coronal and sagittal were made on the screen. On the surface of thebody, Passive Planar Probe was moved by 3D navigation system to determine skin incision where pediclescrews were inserted, then about 2 cm incision was made to place registered Universal Drill Guide. Thecaudal angle and the lateral angle of Universal Drill Guide was adjusted to make its projection on thesagittal and transverse navigation image get through pedicle axis. The channel was drilled by UniversalDrill Guide, then the pedicle screw was inserted. The required connecting rod was measured and bendedto connect the pedicle screws. The injured vertebra was propped to restore the height of the fracturedvertebra and the screw cap was tightened in the end. The pedicle screws and connecting rod were locatedcorrectly and the fracture reduction was satisfactory through the O-arm scan. Then we closed theincision.

Percutaneous short segment pedicle screw �xation withoutscrewing of the fractured vertebra with O-arm navigationThis surgery method was similar to the upper surgery method. During the surgery, no pedicle screws wereinserted into the fractured vertebra, but the upper and lower vertebrae were also propped to restore theheight of the injured vertebra.

Clinical and radiological measurementAll the participants were invited to �nish follow-up investigation one week and one year after the surgery.The follow-up time was at least one year. All the patients received thoracic and lumbar spine positive andlateral digital radiography (DR), computed tomography (CT) (plain scan + coronal sagittal reconstruction + surface reconstruction), and magnatic resonance imaging(MRI) (T1 + T2 + STIR(short time inversionrecovery)). Participants received thoracic and lumbar spine DR and CT one week after the surgery, butonly thoracic and lumbar spine positive lateral DR one year after the surgery. Imaging evaluation indexincluded Cobb angle and percentage of anterior vertebral height (AVH %). The injured vertebral Cobbangle and percentage of anterior vertebral height (AVH%) was measured by collecting all the data of DRpreoperatively, one week after the surgery and one year after the surgery. The measurement of injuredvertebral Cobb angle was as follows: made vertical line of upper vertebra superior endplate extension andlower vertebra subjacent endplate extension respectively on the the lateral thoracic lumbar spine DR, theangle between the two perpendicular lines is the Cobb angle of the injured vertebra. Method of AVH%measurement was the anterior vertebral height of the injured vertebra / the mean value of the anterior

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vertebral height of the upper and lower adjacent segments×100%. Clinical evaluation indexes includingintraoperative bleeding, operation time and incision length were collected preoperatively, one week afterthe surgery and one year after the surgery. Visual Analogue Scale (VAS) and oswestry disability index(ODI) were evaluated preoperatively, one week after the surgery and one year after the surgery as e�cacyevaluation index.

Statistical AnalysisSPSS 20.0 statistical was used for statistical analysis, the comparison of the data in these two groupsadopted independent samples t test and and the comparison of preoperative and postoperative data inthe single group adopted paired t test, P < 0.05 showed statistically signi�cant difference.

ResultsAll of the patients underwent surgery successfully without complications and failure of �xation. Thebasic information of paticipants in the two groups was shown in Table 1, no signi�cant statisticaldifferences were showed in gender, age, trauma causes and injury segments(P > 0.05). In the aspect ofclinical indicators, there was no signi�cant statistical difference in operation time and intraoperativebleeding between the two groups (P > 0.05), but the surgical incision in fractured vertebra screwing groupwas longer than that in no fractured vertebra screwing group (11.95 ± 2.06 cm vs. 10.38 ± 1.36 cm) (P < 0.05) (Table 2). In terms of imaging indicators, the comparison of fractured vertebra Cobb angle betweenthe two groups before and one week after the surgery was not statistically signi�cant (P > 0.05), while thecomparison of Cobb angle one year after the surgery was statistically signi�cant (6.52 ± 3.04° vs. 9.48 ± 5.38°) (P < 0.05). There were statistically signi�cant differences in Cobb angle in the respective groupbefore operation, one week after operation and one year after operation(P < 0.05). The restoration of Cobbangle was relatively obvious one week after the operation. With the recovery of the disease, Cobb anglebecame large, but compared with that before the operation, the Cobb angle was still decreased (Table 3)(P < 0.05). There was no difference in the percentage of preoperatively anterior vertebral height betweenthe two groups preoperatively and one week after the surgery(P > 0.05), while AVH% between the twogroups was statistically signi�cant one year after surgery (87.51 ± 10.67% vs. 78.99 ± 15.13% ) (P < 0.05).Meanwhile comparation of AVH% preoperatively, one-week and one-year postoperatively was statisticallysigni�cant in the respective group (P < 0.05). One week after surgery, AVH% became larger than theformer, while AVH% decreased one year after surgery, but AVH% recovered better than preoperative AVH%(P < 0.05) (Table 3)( Figs. 3 and 4). Preoperative and postoperative VAS and ODI scores of the two groupswere showed in Table 4. All the VAS and ODI scores between this two groups before surgery, one weekafter surgery and one year after surgery had no statistical signi�cance (P > 0.05), while VAS and ODIscores in the respective group before surgery, one week after surgery and one year after surgery haddownward trend. Compared with preoperative VAS and ODI, VAS and ODI decreased signi�cantly oneweek and one year after surgery (P < 0.05).

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Table 1The demographic data of the patients in two groups

Variable Fractured vertebra screwinggroup

(n = 21)

No fractured vertebra screwinggroup

(n = 21)

Pvalue

Gender(female/male)

11/10 11/10 0.883

Age (years) 53.33 ± 6.80 54.05 ± 11.32 0.805

Segment [n (%)]

T11

T12

L1

L2

 

3 (14.3%)

3 (14.3%)

10 (47.6%)

5 (23.8%)

 

3 (14.3%)

3 (14.3%)

12 (57.1%)

3 (14.3%)

0.745

Trauma cause [n(%)]

Falling injury

Tra�c injury

Heavy bruise injury

 

10 (47.6%)

10 (47.6%)

1 (4.8%)

 

9 (42.9%)

10 (47.6%)

2 (9.5%)

0.626

Table 2Comparison of clinical indicators data between the two groups

Variable Fractured vertebra screwinggroup

(n = 21)

No fractured vertebra screwinggroup

(n = 21)

Pvalue

Operation time (min) 160.24 ± 52.84 153.955 ± 28.15 0.633

Incision length (cm) 11.95 ± 2.06 10.38 ± 1.36 0.006*

Intraoperative bloodloss(ml)

99.76 ± 32.15 100.38 ± 23.00 0.619

* P < 0.05

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Table 3Comparison of image indicators data between the two groups

Variable Fractured vertebra screwinggroup

(n = 21)

No fractured vertebra screwinggroup

(n = 21)

Pvalue

Cobb angle ( °)

Preoperative

1 w postsurgeryα

1 y postsurgeryβ

 

12.81 ± 4.25

4.76 ± 2.86

6.52 ± 3.04

 

14.33 ± 6.37

6.62 ± 5.00

9.48 ± 5.38

 

0.368

0.147

0.035*

AVH%(%)

Preoperative

1 w post surgery

1 y post surgery

 

59.13 ± 11.88

94.64 ± 10.22

87.51 ± 10.67

 

64.51 ± 15.76

93.12 ± 15.97

78.99 ± 15.13

 

0.219

0.716

0.041*

α w represents week, β y represents year

* P < 0.05

Table 4Preoperative and postoperative VAS and ODI scores of the two groups

Variable Fracturedvertebrascrewing group

(n = 21)

No fractured vertebrascrewing group

(n = 21)

Pvalue

VAS for back pain

Preoperative

1 w post surgeryα

1 y post surgeryβ

 

8.2 ± 0.8

2.6 ± 0.5

1.6 ± 0.5

 

7.9 ± 0.8

2.4 ± 0.5

1.6 ± 0.5

 

0.267

0.367

0.760

ODI (%)

Preoperative

1 w post surgeryα

1 w post surgeryβ

 

91.3 ± 3.7

46.7 ± 15.2

5.5 ± 1.4

 

91.4 ± 3.6

48.1 ± 14.9

5.5 ± 1.5

 

0.933

0.775

0.915

α w represents week, β y represents year

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Discussion

Superiority of percutaneous minimally invasive technologyand O-arm navigation technologyTraditional posterior open surgery has more bleeding, longer incision, more paravertebral muscledissection, severer postoperative pain, and slower recovery than novel percutaneous minimally invasivesurgery[10]. The advantages of percutaneous minimally invasive technology are more obvious inavoiding above-mentioned problems, especially for patients with multiple injuries combined with traumain other parts[11]. In recent years, with the development of minimally invasive technology and patients'demand for minimally invasive surgery, percutaneous minimally invasive surgery has been widely used inthe treatment of spinal fractures[12, 13]. Percutaneous minimally invasive technology can effectivelyreduce intraoperative bleeding and intraoperative and postoperative blood transfusion, which isconducive to reduce the use of blood products and promote the early recovery of patients. On the otherhand, it can also reduce bed-related complications and hospitalization costs[14]. However, compared withthe traditional open approach technique, percutaneous pedicle screw technique requires more anatomicalknowledge, operational skills and experience of the surgeon which has a longer learning curve. Moreover,increasing the operation time and intraoperative bleeding may happen if the surgeon is not familiar withthe minimally invasive operation[15, 16]. In addition, percutaneous nailing can also increase the risk ofdamaging the pedicle, resulting in damage to nerve function and facet joints[17–19]. The addition ofscrews to the injured vertebra will further increase the above risks and surgical costs. Current studieshave shown that 3D navigation technology can signi�cantly improve the precision of screw placement byorthopedic surgeons, reduce surgical time, and enable �nish the learning curve of percutaneous screwplacement technology in a reasonable time[20].

At the present, the common navigation technologies in clinic include preoperative CT navigation,isocentric C-arm three-dimensional navigation, and intraoperative O-arm real-time navigation, amongwhich intraoperative O-arm real-time navigation is the most advanced. O-arm in navigation can providereal-time 3D reconstruction, high-de�nition images, which can show a variety of anatomical structureclearly to greatly improve the accuracy of pedicle screw insertion and the operation time can be greatlyreduced at the same time. In addition, O-arm allows many young surgeons with less experience to getaccess to the practice. Of course, O-arm also has some disadvantages, such as high price, increasedsurgery costs, intraoperative changes in patient position will lead to decreased accuracy of navigation,and the use of navigation also requires a certain amount of time to learn and experience.

There was no statistical difference in operation time, intraoperative bleeding in these two groups in thisstudy. Although incision length contrast is statistically signi�cant, the difference is very small, the reasonmay be two more screws were inserted in the injured vertebra in fractured vertebra screwing group.Compared with the traditional open surgery, the incision of two groups were shorter, which can helppatients reduce postoperative pain, shorten the recovery time.

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Whether the injured vertebra should be insertedInjured vertebral space was indirectly opened by the force between the upper and lower vertebral bodyfrom the nail rod system in the traditional across injured vertebral four pedicle screw �xation surgery. Theintraoperative and postoperative clinical effect of this surgery maybe satisfactory in the short term, whilein the long run, the loss of the correction effect and the failure of internal �xation may happened bacausefour pedicle screw �xation is a kind of double plane �xation, easy resulting to quadrilateral effect andsuspension effect[21]. Dick et al. reported that additional pedicle screw placement in the injured vertebracan improve the biomechanical stability of the screw rod system by reducing the stress of each pediclescrew by supporting the anterior column[22]. This operation of six pedicle screws placement can changethe original double plane �xation way into three plane �xation by the injured vertebra pedicle screwsplacement, avoiding the quadrilateral effect and suspension effect effectively[21]. During the procedure,the injured vertebral can be thrust forward directly, which is bene�cial to the reduction of kyphosis of theinjured vertebra. In addition, the increased screws disperse stress and reduce fatigue of internal �xation,preventing internal �xation failure. Mahar et al. examined biomechanical property of L1-3 in sixspecimens of human corpse, they adopted L2 segment as a simulative damage section, divided into twogroups respectively (fractured vertebra screwing group and fractured vertebra screwing group)[23], theresults showed that the biomechanics of fractured vertebra screwing group signi�cantly stronger than nofractured vertebra screwing group. It was also proved by Baaj et al. [24]through similar experiments onhuman cadaver. Bolesta et al. simulated the L2 vertebral body burst fracture on the calf spine, andconducted the biomechanical test[25], the results showed that the stability of �xed segment could beincreased by 68% on average in the fractured vertebra screwing group, even as much as in the long-segment �xation. Saglam et al. conducted a study on four groups of patients receiving 4-segment cross-injury vertebra �xation, 3-segment cross-injury vertebra �xation, 4-segment cross-injury vertebra �xationand 5-segment cross-injury vertebra �xation, and obtained similar results[26].

In addition to the real-time correction effect of injured vertebra in the surgery, the long-dated correctiveeffect is also very ideal in the fractured vertebra screwing surgery[27, 28], but compared with across theinjured vertebra �xation, two more screws need to be inserted in fractured vertebra �xation surgery. If thetraditional posterior midline open access procedure was adopted, there would be more complicationsincluding longer operation time, larger incision length, more intraoperative bleeding[29]. Ye et al. studiedthe short-term and long-term clinical e�cacy of 24 patients receiving no injured vertebra �xation and 20patients receiving injured vertebra �xation, the results showed that the maintenance of the curative effectof injured vertebra �xation group was better[9]. In a meta analysis[30], comparation clinical curativeeffects of 310 patients in 6 groups receiving injured vertebra �xation and no injured vertebra �xationrespectively found that missing of AVH% of injured vertebra �xation group was less than no injuredvertebra �xation group after correction of the Cobb angle, and the internal �xation failure rate is lower, butthe operation time and intraoperative bleeding of injury of vertebral �xation group was slightly higher.

In this study, Cobb angle, AVH%, VAS score and ODI score were statistical signi�cant preoperatively, oneweek after surgery and one year after surgery in the respective group. It was proved that both injured

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vertebra screwing and no injured vertebra screwing had the relatively accurate clinical effect ofrestoration and the effect of pain relief. Postoperative incision pain and discomfort after internal �xationresulting to daily life limited would get relief and basically returned to normal one year after the surgery.However, the Cobb angle and the AVH% of the injured vertebra screwing one year after surgery wasstatistically different from that in the no injured vertebra screwing group, indicating that the maintenanceeffect of injured vertebral screwing group was better. The possible reason was that injured vertebra�xation could directly exert forward force on the injured vertebra. In the long term, the distraction effect ofthe upper and lower vertebra and nail rod system was better and the stability of internal �xation washigher with the injured vertebra �xed.

In this study, short-term curative effect of percutaneous short segment pedicle screw �xation withscrewing of the fractured vertebra with O-arm navigation in the treatment of thoracolumbar fractures wassimilar to that without screwing of the fractured vertebra with O-arm navigation in the treatment ofthoracolumbar fractures, but the long-term e�cacy was better. Of course, there were still somede�ciencies in this study, due to the strict inclusion criteria and need of at least one year follow-up, thenumber of cases meeting the requirements is relatively small. In addition, only one year postoperativefollow-up was collected in this study, and the results of the longer follow-up were not included. Therefore,the longer follow-up was necessary to evaluate the e�cacy, and the subsequent follow-up was needed tofurther verify the conclusions of this paper.

AbbreviationsVAS= visual analogue scales, AVH= anterior vertebral height, ODI= oswestry disability index

DeclarationsNo benefits in any form have been or will be received from a commercial party related directly orindirectly to the subject of this manuscript.

Ethics approval and consent to participate

The study was approved by Ethics Committee of the First A�liated Hospital of Soochow University. Allpatients gave written informed consent prior to their inclusion of the study.

Consent for publication

Not applicable. 

Availability of data and material

The datasets used and/or analysed during the current study available from the corresponding author onreasonable request.

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Competing interests

The authors have declared that there are no con�icts of interest.

Funding

This work was supported by the National Nature Science Foundation of China (grant no. 81802682 and81972104), Natural Science Foundation of Jiangsu Province (grant no. BK20180199) and SuzhouScience and Technology Program for People's Livelihood (SS201858).

Authors' contributions

SXF, PP, PY contributed to draft the manuscript text. HLY, HQM and KWC designed the concept, TX, ZXL,XH and XYZ revised the manuscript. All authors read and approved the �nal manuscript.

Acknowledgements

The present study was supported by The First A�liated Hospital of Soochow University.

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Figures

Figure 1

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Lateral (A) radiograph and CT (B) of a 35-year-old male with L1 vertebral fracture. Receivingpercutaneous short segment pedicle screw �xation without screwing of the fractured vertebra with O-armnavigation and the Cobb angle and AVH% get restoration one week (C) and one year (D) after the surgery.

Figure 2

A 52-year-old female was diagnosed L1 vertebral fracture by DR and CT (A B). Percutaneous shortsegment pedicle screw �xation without screwing of the fractured vertebra with O-arm navigation wasoperated (C), and he got the satisfactory recovery (D).