A study on the accuracy of screw placement in the apical region of patients with Lenke1 adolescent idiopathic scoliosis under intraoperative navigation

doi:10.21203/rs.3.rs-2252391/v1

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Research Article

A study on the accuracy of screw placement in the apical region of patients with Lenke1 adolescent idiopathic scoliosis under intraoperative navigation

https://doi.org/10.21203/rs.3.rs-2252391/v1

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Background

To compare the accuracy and deviation direction of pedicle screw placement in the apical region of patients with Lenke type 1 adolescent idiopathic scoliosis (AIS) under navigation using navigation calibration techniques, and to analyze the related factors affecting the deviation of screw placement under navigation and the clinical significance of navigation calibration techniques.

Methods

This was a retrospective analysis of 43 patients who were diagnosed with Lenke type 1 AIS in our hospital from October 2017 to October 2020 and underwent posterior scoliosis correction and internal fixation with navigation assistance. According to whether navigation calibration technology was used during the operation, 43 patients were divided into two groups: the navigation group (n = 21) and the navigation calibration group (n = 22). The basic information, Risser sign, preoperative and postoperative Cobb angle and postoperative correction rate of the two groups were recorded, and the accuracy of screw placement in the apical vertebral region was evaluated according to the Rao classification.

Results

A total of 414 screws were placed between the two groups, 202 in the navigation group and 212 in the navigation calibration group. The excellent and good rates of screw placement in the apical region, concave side and convex side were 85.76%, 78.49% and 92.73%, respectively, in the navigation calibration group, which were significantly higher than 76.47%, 66.19% and 85.77%, respectively, in the navigation group (P = 0.001, P = 0.007, P = 0.016). The rate of grade 2 screw placement in the navigation calibration group (9.0%) was significantly lower than that in the navigation group (15.3%) (P = 0.04). In addition, the rates of parietal vertebral region and concave and convex medial wall ruptures in the navigation calibration group were 2.4%, 3.8% and 0.9%, respectively, which were significantly lower than 11.9%, 16.0% and 7.8%, respectively, in the navigation group, and the difference between the two groups was statistically significant (P = 0.001, P = 0.004, P = 0.011). In addition, the wall-breaking rates of the apical vertebral region and its concave and convex medial walls in the navigation calibration group were 2.4%, 3.8%, and 0.9%, respectively, which were significantly lower than those in the navigation group (11.9%, 16.0%, and 7.8%, respectively). The difference between the two groups was statistically significant (P = 0.001, P = 0.004, P = 0.011). No spinal cord or neurovascular injury occurred in either of the two groups.

Conclusion

Compared with simple navigation, a simple calibration technique can effectively prevent navigation deviation, significantly improve the accuracy of screw placement in the apical vertebral region of AIS patients, reduce the perforation rate of the medial wall of the misplaced screw, and improve the safety of the operation.

Adolescent idiopathic scoliosis

Navigation

Navigation calibration Pedicle screw

Apical region

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine with an unknown etiology, often accompanied by a three-dimensional imbalance of the sagittal, coronal and cross-section of the spine [1, 2]. There are obvious anatomical malformations, such as pedicle stenosis, vertebral rotation and spinal cord deviation, in the apical vertebrae of patients with AIS, resulting in a high risk of screw placement and a high rate of screw misplacement in the apical vertebrae[3–5]. Misplaced screws might cause damage to adjacent structures, such as the spinal cord and neurovascular structures[6–8]. Therefore, it is important to improve the accuracy of screw placement in the apical vertebrae of AIS patients. Several current studies have shown that computer navigation can significantly improve the accuracy of pedicle screw placement in AIS patients[9–11]. However, intraoperative navigation might cause screw misplacement due to various factors causing the deviation of computer navigation [12]. In addition, studies have shown that there was no significant difference in the accuracy of screw placement between computer-assisted navigation and unarmed technology in AIS patients, but patients experienced more radiation exposure[13]. Therefore, to improve the accuracy of screw placement in the apical vertebra of AIS patients under computer navigation, the research team proposed a simple calibration technique for intraoperative navigation, but there was no relevant research report in the literature.

The purpose of this study was to compare the accuracy and deviation direction of screw placement in the apical vertebral region of Lenke 1 AIS patients under navigation using intraoperative navigation calibration techniques, and to analyze the related factors affecting the deviation of navigation screw placement and the clinical significance of intraoperative navigation calibration techniques.

Participants

A total of 43 patients with Lenke type 1 AIS who underwent posterior scoliosis orthopedic internal fixation under computer navigation in our hospital between October 2017 and October 2020 were enrolled. All patients provided informed consent, which was signed by the legal guardian and approved by the Medical Ethics Committee. The navigation group included 21 patients, 5 males and 16 females, with an average age of 13.76 ± 2.45 years, Risser sign 3.38 ± 1.20°, and preoperative Cobb angle 64.33 ± 18.66°. The navigation calibration group included 22 patients, 7 males and 15 females, with an average age of 14.18 ± 2.28 years, Risser sign 3.36 ± 1.05, and preoperative Cobb angle 71.95 ± 21.60°. The inclusion criteria were as follows: ① all patients were diagnosed with Lenke type 1 AIS by two senior spinal surgeons according to their symptoms, signs and imaging examination; ② patients had complete preoperative and postoperative imaging data; and ③ all operations were performed by a senior spinal surgeon. The surgical method was navigation-assisted posterior orthopedic internal fixation. The exclusion criteria were as follows: ① patients with a history of spinal surgery or anterior spinal release; ② patients with other spinal diseases, such as vertebral tumors, vertebral tuberculosis and ankylosing spondylitis; and ③ patients with a follow-up time less than 1 year and incomplete clinical and imaging data.

Surgical Methods

(1) Installation of the electrophysiological system: general intravenous anesthesia after installation of cerebral cortex somatosensory evoked potential/motor evoked potential for neurophysiological monitoring. (2) Exposing the fusion segment: After the patient was placed in the prone position and disinfected with the towel, the bone was taken 2 cm below the right posterior superior iliac spine, and then a longitudinal skin incision was made in the posterior median. The skin was cut according to the layer, and the paravertebral muscles were peeled off. The spinous process, lamina and facet joint were exposed, and electrocoagulation was used to stop bleeding. (3) Navigation group: ① Calibration of navigation equipment was performed before the start of each operation, after the navigation frame was installed and connected to the navigation equipment for ISO-C scan, the image was automatically scanned and entered into the navigation system to complete the registration. (4) Navigation calibration group: ① Navigation calibration and needle positioning: 20 ml sterile saline was injected via syringe into the spinous process, and using a needle holder, we ensured that the syringe was placed parallel to the long axis of the spinous process to a depth not exceeding the length of the spinous process (Fig. 1a ~ b). ② Navigation calibration verification: The navigation registration step is the same as in the navigation group. After the navigation registration is completed, the navigation tracer can be used to align the calibration positioning needle before the nail is placed. For example, the positioning needle and the navigation tracer image point offset < 2 mm or the angle offset < 5°. The navigation probe can be adjusted in the opposite direction and angle according to the image offset direction and angle, and the angle of the navigation tracer and the calibration positioning needle is confirmed to complete the navigation calibration (Fig. 1d ~ i). If the image point offset between the positioning needle and the navigation tracer is ≥ 2 mm or the angle offset is ≥ 5°, it is necessary to check whether the transmission path is occluded and whether the reference frame is loose or displaced. If the transmission path is occluded, it can be adjusted according to the direction and angle of the image offset. If the navigation frame is loose and displaced, ISO-C scan can be performed again for image registration after refixation. (5) Preparation of the screw path: The best entry point and entry angle were determined with the assistance of navigation. The entry channel was prepared by a high-speed grinding brick. The navigation probe was used again to explore the bony structure of the entry channel and confirm whether the entry direction was correct. After confirmation, tapping and screw placement were performed. (6) Three-dimensional correction of spine: facet joint fusion was performed after pedicle screw placement, and correction was performed by rotating the screw rod, compression, distraction and direct derotation. Finally, the vertebral plate cortex was removed with a high-speed grinding brick, autologous iliac bone and artificial bone were placed, and a drainage tube was placed and sutured layer by layer.

Evaluation Standard Of Postoperative Pedicle Screw Accuracy

The position of the pedicle screw in the apical vertebral region was evaluated on postoperative three-dimensional CT scan, the position of the screw penetrating the cortical bone was recorded, and the distance of the penetrating cortical bone was measured. According to the Rao classification, the degree of cortical perforation was evaluated [14]: grade 0, the screw did not penetrate the pedicle or vertebral cortex; level 1, penetration distance was 4 mm (Fig. 2a ~ d). According to the location of the pedicle screw and cortical perforation, it is divided into [15]: medial and lateral cortical perforation of the pedicle, anterior vertebral wall or intervertebral foramen perforation (Fig. 2e ~ h).

Statistical Analysis

Statistical analysis was performed using SPSS 26.0 software. Continuous variables were expressed as (x ± s). The t test was used to compare the measurement data between the two groups. The chi-square test and Fisher's exact test were used to compare the accuracy and deviation direction of screw placement between the two groups. P < 0.05 was considered statistically significant.

Participants

The study included 43 patients, 21 in the navigation group and 22 in the navigation calibration group. The preoperative main curve Cobb angle of the navigation calibration group was 71.95° ± 21.60° higher than that of the navigation group 64.33° ± 18.66°, while the postoperative correction rate was 80.56° ± 9.24° lower than that of the navigation group 83.33° ± 8.64°, but there was no significant difference between the two groups. In addition, there was no significant difference in sex, age, BMI, Risser sign or the number of screws in the apical vertebral region between the two groups (Table 1).

Table 1 Basic information and radiological date of the two groups (X±s)

Basic information	Navigation group (n=21)	Navigation calibration group (n=22)	χ^２/t	P
Sex (M/F)	5/16	7/15	0.574	0.256
Age (year)	13.76±2.45	14.18±2.28	-0.582	0.433
BMI	16.88±2.22	17.89±2.64	-1.343	0.451
Risser sign	3.38±1.20	3.36±1.05	0.050	0.553
Preoperative main curve Cobb angle ( ° )	64.33±18.66	71.95±21.60	-1.236	0.423
Postoperative main curve Cobb angle ( ° )	11.05±7.46	14.91±11.12	-1.330	0.230
Main bending correction rate (%)	83.33±8.64	80.56±9.24	35.054	0.931
Number of nails ( pieces )	9.62±0.74	9.64±0.73	-0.077	0.901

Note: P < 0.05 was considered statistically significant.

Accuracy Of Pedicle Screw Placement

A total of 414 pedicle screws were placed in the apical vertebral region of the two groups, of which 202 screws were placed in the navigation group and 212 screws were placed in the navigation calibration group (Table 2). The excellent and good rate of screw placement (grade 0 and grade 1) in the apical vertebral area of the navigation calibration group was 85.76%, which was significantly higher than the 76.47% of the navigation group. At the same time, the excellent and good rates of screw placement on the concave and convex sides of AIS patients in the navigation calibration group were 78.49% and 92.73%, respectively, which were significantly higher than the rates of 66.19% and 85.77%, respectively, in the navigation group. The difference between the two groups was statistically significant (P = 0.001, P = 0.007, P = 0.016). In addition, the 0-grade screw placement rates in the navigation calibration group and its concave apical region were 80.2% and 75.0%, respectively, which were significantly higher than 70.3% and 64.0%, respectively, in the navigation group, while the 2-grade screw placement rate was 9.0%, which was significantly lower than 15.3% in the navigation group (P = 0.045, P = 0.019, P = 0.04). Although the screw placement rate of the navigation calibration group was 7.4% lower than that of the navigation group (13.7%), there was no significant difference between the two groups (P > 0.05).

Misplaced screw puncture direction

The total number of cortical screws that penetrated in the two groups was 102, including 60 in the navigation group and 42 in the navigation calibration group. The distribution of pedicle screws penetrating the cortex between the two groups (Fig. 3). The rate of pedicle screws penetrating the medial cortex in the navigation calibration group was 2.4%, which was significantly lower than that in the navigation group (11.9%). Moreover, the rate of medial wall rupture in the concave and convex sides of the apical vertebra in AIS patients in the navigation calibration group was 3.8% and 0.9%, respectively, which was significantly lower than that in the navigation group (16.0% and 7.8%, respectively). The difference between the two groups was statistically significant (P = 0.001, P = 0.004, P = 0.011). However, there was no significant difference in the rate of anterior wall, lateral and intervertebral foramen rupture between the two groups (Table 3). Figure 4 is a typical case.

Table 2 Distribution of screws position in two groups (n,%)

		Navigation group				Navigation calibration group
	Concave side		Convex side		Total	Concave side	Convex side			Total
Grade 0		64(64.0%)	78(76.5%)	142(70.3%)		78(75.0%)*		92(85.2%)	170(80.2%)*
Grade 1		2(2.0%)	10(9.8%)	12(5.9%)		4(3.8%）		8(7.4%)	12(5.7%)
Grade 2		20(20.0%)	11(10.8%)	31(15.3%)		12(11.5%)		7(6.5%)	19(9.0%)*
Grade 3		14(14.0%)	3(2.9%)	17(8.4%)		10(9.6%)		1(0.9%)	11(5.2%)
superior rate(%)		66.19	85.77	76.47		78.49*		92.73*	85.76*
Total		100(100%)	102(100%)	202(100%)		104(100%)		108(100%)	212(100%)
		P ¹=0.045	P ²=0.04	P ³=0.019		P⁴=0.001		P⁵=0.007	P⁶=0.016

Note: Comparison of pedicle screw penetration between the two groups: P¹: Comparison of grade 0 screw rate between the two groups; P²: Comparison of grade 2 screw rate between the two groups; P³: comparison of concave side 0 screw rate between the two groups; P⁴: Comparison of the excellent and good rate of screw placement between the two groups; P⁵: comparison of the excellent and good rate of concave side screw placement between the two groups; P⁶: Comparison of the excellent and good rate of convex side screw placement between the two groups; * indicates a statistically significant difference, P < 0.05.

Table 3 Distribution of misplaced screws penetrating the cortex in the two groups (n,%)

	Navigation group				Navigation calibration group
	Concave side	Convex side		Total	Concave side	Convex side			Total
Anterior	10(10.0%)	6(5.9%)	16(7.9%)		11(10.6%)		5(4.6%)	16(7.5%)
Lateral	9(9.0%)	7(6.9%)	16(7.9%)		10(9.6%）		8(7.4%)	18(8.5%)
Medial	16(16.0%)	8(7.8%)	24(11.9%)		4(3.8%)*		1(0.9%)*	5(2.4%)*
Foramen	1 (1.0%)	3(2.9%)	4(2.0%)		1(1.0%)		2(1.9%)	3(1.4%)
Total	36(36%)	24 (23.5%)	60(29.7%)		26(25.0%)		16(14.8%)	42(19.8%)
	P ¹=0.001	P ²=0.004	P ³=0.011

Note: Comparison of the medial, lateral, anterior vertebral wall and intervertebral foramen perforation direction between the two groups; P¹: Comparison of the medial wall perforation rate between the two groups; P²: Comparison of the perforation rate of the inner wall of the concave side between the two groups; P³: Comparison of the perforation rate of medial wall on convex side between the two groups;* indicates a statistically significant difference, P < 0.05.

Complications

There were 2 patients with complications in the two groups, 1 in the navigation group and 1 in the navigation calibration group. In the navigation group, one screw penetrated the medial cortex and invaded the spinal canal in 1 patient, but intraoperative neurophysiological monitoring showed that the patient’s condition was stable, and no lower limb sensory abnormalities occurred during the postoperative follow-up. In the navigation calibration group, pleural damage occurred in 1 patient, and chest distress and shortness of breath occurred after the operation, but the last follow-up showed that the patient recovered well. In addition, no spinal cord or neurovascular injuries occurred in the two groups during the perioperative period. The patients were followed up for 14-24 months (mean, 16.5 months). There was no screw loosening, screw breakage or rod breakage.

In this study, the accuracy of screw placement in the apical vertebral region of the navigation calibration group was significantly better than that of the navigation group. Additionally, the accuracy of screw placement in the concave side of the apical vertebral region of AIS patients was better, and the rate of medial wall rupture of the apical vertebral region and its concave side was reduced. Therefore, compared with simple navigation, intraoperative navigation can significantly improve the accuracy of screw placement in the apical vertebra of AIS patients after simple calibration. However, to improve the accuracy of the apical vertebral region in AIS patients, the problem of intraoperative navigation deviation is also worthy of attention and research.

There are many factors that affect the deviation of navigation in screw placement: (1) Spinal displacement. AIS patients with spinal flexibility can achieve good orthopedic results, but screw placement deviations can occur when vibrations shifts during screw placement, resulting in three-dimensional spatial position changes on the spinal and navigation reference frame or reference frame loosening, resulting in navigation image offset and subsequent decreases in screw placement accuracy [16, 17]. In particular, there is obvious stenosis and deformity in the pedicle of the apical vertebra of AIS patients. When intraoperative spinal displacement leads to navigation deviation, screw placement is prone to misplacement. The simple navigation calibration technique is used for real-time navigation calibration during the operation, to avoid navigation deviation caused by spinal displacement due to intraoperative operation vibration, and to improve the accuracy of screw placement in the apical vertebra. (2) Displacement and loosening of the navigation frame. Oba et al.[17] reported a navigation-assisted AIS screw perforation and screw placement sequence relationship and influencing factors because in adolescent patients with an immature spinous process, the navigation reference frame clipped on the spinous process can be fixed due to instability, loosening, and displacement. This study suggests that the loosening or displacement of the reference frame during screw placement leads to navigation deviation, which can cause the cortical perforation rate of the next screw to be as high as 26.7%. In this study, the top vertebral area was mainly located in the middle thoracic vertebra, and the thoracic spine was thin and immature. Therefore, the reference frame is prone to loosening when placing screws in the apical vertebral region, resulting in navigation deviation. In addition, the closer the distance between the screw and the reference frame is, the higher the deviation rate of pedicle screw placement. It may be that the spine vibrates strongly during the screw placement process, causing the reference frame to loosen, resulting in navigation deviation[18]. (3) Light transmission path occlusion. During the operation, the reference frame can interfere with the light transmission path if the helper or nurse blocks the transmission path or the reflection ball being stained with blood during the delivery of the instrument, resulting in deviation of the navigation image and an increase in the screw misplacement rate. Additionally, the overhead light directly illuminating the reference frame also affects the ability to reflect infrared light back to the camera, causing the navigation image to shift[19].

Computer navigation is often affected by spinal displacement, reference frame loosening or displacement, image transmission path occlusion and other factors, resulting in navigation image offset and an increased pedicle screw misplacement rate[16–19]. To prevent navigation deviation and improve the accuracy of screw placement in AIS patients, our research team proposed a simple calibration technique for intraoperative navigation. This study found that the excellent and good rate of screw placement in the apical vertebra of AIS patients after calibration of intraoperative navigation was 85.76%, which was significantly higher than the 76.47% rate of simple navigation, and improved the accuracy of pedicle screw placement on the concave side and reduced the perforation rate of the medial wall.

The vertebral body connects the spinous process into one through the pedicle. When the vertebral body rotates, the spinous process will also rotate to a certain extent, and the normal anatomical screw placement position will also change accordingly. However, traditional navigation cannot accurately reflect the changes in the spinal anatomical structure in real time, which leads to deviation of the navigation screw placement point[20]. The intraoperative simple calibration technique involves placing the positioning needle on the spinous process to prevent displacement of the positioning needle so that the positioning needle is also connected to the vertebral body and pedicle. The navigation tracer can accurately obtain the offset direction and angle of the navigation image through the positioning needle and perform real-time calibration according to the offset direction and angle. Preoperative navigation calibration is a routine step in navigation operations for effectively avoiding errors caused by navigation registration[21]. In this study, intraoperative navigation calibration is used to verify the accuracy of navigation during navigation to avoid errors caused by intraoperative operation or reference frame loosening. Therefore, simple navigation calibration technology can effectively prevent navigation deviation caused by spinal displacement, reference frame loosening and occlusion of the optical path transmission path during screw placement in the apical vertebral region of AIS patients. Moreover, it can also avoid screw misplacement caused by loosening or displacement of the reference frame and occlusion of the navigation image transmission path to a certain extent. With continuous upgrade of navigation software and intraoperative three-dimensional CT, the errors caused by navigation computer software and hardware in the process of screw placement in the apical vertebra of AIS patients will continue to decrease. However, there is no way to avoid navigation deviation caused by spinal displacement caused by intraoperative operation by intraoperative three-dimensional CT.

The limitations and shortcomings of this study are as follows: (1) This study is a retrospective single-center study. There were few cases included in the study. Prospective randomized double-blind studies with strict designs are needed in the future, and multicenter and large samples are needed for verification. (2) Navigation calibration technology relies on the doctor's personal experience and understanding of the navigation principle and lacks objective evaluation criteria. (3) This study only included AIS, and the lack of research on other types of scoliosis, which later also included other types of scoliosis patients, was studied.

In summary, compared with simple navigation, a simple calibration technique can effectively prevent navigation deviation, significantly improve the accuracy of screw placement in the apical vertebral region of AIS patients, reduce the perforation rate of the inner wall of the misplaced screw, and improve the safety of the operation.

AIS

adolescent idiopathic scoliosis

Acknowledgements

Not applicable

Authors’ contributions

Xianbo He performed all the experiments and wrote the manuscript.

Guojun Li participated in the collection of experimental data.

Tao Huang and Xuejian Yang are responsible for document collection.

Zhibin Meng completed the repeatability verification of the experiment.

Huanxiong Chen conceived and designed the study. The authors read and approved the final manuscript.

Funding

Supported by National Natural Science Foundation of China (82160435, 81902270),

Supported by Hainan Province Clinical Medical Center.

Availability of data and materials

Please contact the corresponding author for data requests.

Ethics approval and consent to participate

The ethical committee approved the study of the participating hospitals. All subjects signed informed consent by each patient. All clinical investigations had been conducted according to the principles expressed in the Declaration of Helsinki.

Consent for publication

Written informed consent for publication was obtained from all participants.

Competing interests

The authors declare that they have no competing interests.

Author details

1 Graduate School, Hainan Medical University, Haikou, China.

2 Department of Spine Surgery, The First Affiliated Hospital of Hainan Medical University, Haikou, China.

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No competing interests reported.

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A study on the accuracy of screw placement in the apical region of patients with Lenke1 adolescent idiopathic scoliosis under intraoperative navigation

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Abstract

Background

Methods

Results

Conclusion

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Introduction

Methods

Participants

Surgical Methods

Evaluation Standard Of Postoperative Pedicle Screw Accuracy

Result

Participants

Accuracy Of Pedicle Screw Placement

Complications

Discussion

Limitations

Conclusion

Abbreviations

Declarations

References

Additional Declarations

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