Abstract
Objective
The pedicle screw technique has been widely used in adolescent idiopathic scoliosis orthopedic surgery, but misplacement of screws may damage important structures such as blood vessels and nerves around the pedicle, resulting in serious consequences. Therefore, our research team has independently developed a surgical tool to assist in the placement of pedicle screws. This study aims to investigate the safety and accuracy of postural awareness tool assisted nail placement in orthopedic surgery for adolescent idiopathic scoliosis.
Method
A retrospective analysis was performed on 24 adolescent patients with idiopathic scoliosis admitted to our hospital from July 2019 to July 2022, including 10 males and 14 females, with an average age of 14.88 ± 2.36 years (10–19 years). The mean follow‐up was 15.67 ± 2.20 months (12–20 months). We divided the patients into postural awareness group (n = 12) and C‐arm group (n = 12) according to whether the postural awareness surgical tool was used during the operation. All patients were treated with posterior spinal orthopedic surgery. The postural awareness group was assisted by pedicle screw placement with a postural awareness surgical tool, while the C‐arm group was given a pedicle screw placement with freehand technique. The operative time, intraoperative blood loss, intraoperative fluoroscopy times, nail placement related complications, nail placement accuracy, and scoliosis correction rate were recorded and compared between the two groups.
Results
The operative time, intraoperative blood loss and fluoroscopy times in the postural awareness group were significantly lower than those in the C‐arm group, with statistical significance (p < 0.05). The postural awareness group implanted 163 screws with an accuracy rate of 91.41%, while the C‐arm group implanted 159 screws with an accuracy rate of 83.02%. The accuracy rate of screw placement in the postural awareness group was higher than that in the C‐arm group, with a statistically significant difference (p = 0.024). According to the imaging of the patients, there was no significant difference between the Cobb Angle of the main bend measured at three time points before surgery, 1 week after surgery and the last follow‐up between the two groups. Similarly, there was no significant difference in the rate of lateral curvature correction between the two groups.
Conclusion
The application of postural awareness surgical tool in posterior orthopedic surgery for adolescent idiopathic scoliosis can improve screw placement accuracy, shorten screw placement time, and make auxiliary screw placement safer and more accurate.
Keywords: Adolescent idiopathic scoliosis, Nailing accuracy, Pedicle screw, Postural awareness surgical tool
The postural awareness surgical tool consists of two parts: the surgical approach cone with the attitude sensing information module and the corresponding APP software (WTAPP‐release). The application of postural awareness surgical tool in posterior correction of adolescent idiopathic scoliosis can improve the accuracy of screw placement and shorten the time of screw placement.
Introduction
Adolescent idiopathic scoliosis (AIS) is a complex early‐onset three‐dimensional spinal deformity and the most common type of idiopathic scoliosis in children. Studies have shown that the incidence of scoliosis in China ranges from 0.6% to 2.0%, of which idiopathic scoliosis accounts for about 90%. 1 , 2 , 3 For patients with early or mild scoliosis, orthotic therapy is mainly used to slow down the progression of scoliosis and improve clinical symptoms. For patients with progressive scoliosis or severe scoliosis (Cobb Angle ≥ 40°) who fail to respond to orthotic therapy, surgical treatment is often required. 4 Currently, the surgical method commonly used is pedicle screw internal fixation orthopedic surgery, which can generally achieve good fixation results and satisfactory coronal orthosis. 5 However, AIS patients are often accompanied by vertebral rotation or small pedicle, and traditional nail placement is difficult and complicated, which can easily lead to screw deviation from the predetermined track and affect the accuracy of nail placement. 6 When pedicle screws penetrate the pedicle, they are easy to damage nearby important anatomical structures such as blood vessels and nerves, leading to a series of postoperative complications and seriously reducing patients' quality of life. 7 , 8 Therefore, clinicians have developed a variety of techniques to assist pedicle screw placement to reduce the incidence of screw misplacement. In recent years, with the development of science and technology, a variety of auxiliary pedicle screw placement techniques have been gradually applied to clinical medical work, and promoted the development of clinical surgery to a greater extent in terms of precision, and solved many medical problems that could not be solved before. 9 , 10 , 11 For example, the image navigation system represented by the O‐arm navigation, the surgical robot assistance system represented by the Mazor robot, and more advanced virtual reality and other technologies. These auxiliary navigation systems have significantly improved the accuracy rate of pedicle nail placement in spinal surgery, but there are still various problems. 12 , 13 The assistance of robot systems significantly improves the accuracy of screw placement, but it is prone to systematic errors during the processes of 3D image data reconstruction and automatic image registration. To achieve the clinical precision required, digital virtual reality technology still needs further breakthroughs in core technologies. The O‐arm navigation system uses virtual real‐time image tracking technology, and intraoperative patient respiratory motion, spinal displacement, deformation, and changes in the position of the reference frame can cause errors between the image and the real position, known as image drift, and screw misplacement still occurs. It is crucial to develop a surgical assist tool that can accurately restore the pose information of screw placement during surgery, in order to further improve the accuracy and safety of screw implantation.
Therefore, the research team independently developed a postural awareness surgical tool to assist pedicle screw implantation. In this study, we compared the clinical effects of spinal orthopedic surgery assisted by posture‐sensing surgical tools and traditional C‐arm‐guided spinal orthopedic surgery. Therefore, the purpose of this study is to explore the following: (i) to evaluate the safety of the postural awareness surgical tool by comparing the operation time, intraoperative blood loss, and intraoperative fluoroscopy times between the two groups; to analyze the accuracy of the postural awareness surgical tool by comparing the accuracy rate of pedicle screw placement between the two groups; to evaluate the effectiveness of the postural awareness surgical tool by comparing the preoperative and postoperative main curve Cobb angles between the two groups; (ii) to explore the advantages of the postural awareness surgical tool compared to traditional C‐arm guided spinal orthopedic surgery; and (iii) to analyze and summarize the experiences in using the postural awareness surgical tool and discuss what needs attention during use.
Materials and Methods
Inclusion and Exclusion Criteria
Inclusion criteria: (i) the orthotic treatment was ineffective and the lateral curvature was progressive; (ii) posterior orthopedic internal fixation was used, and the operations were all completed by senior orthopedic surgeons; (iii) patients with Lenke1 or type 2 AIS, the Cobb Angle of the main curvature ≥40°; and (iv) the shortest follow‐up period is 12 months.
Exclusion criteria: (i) patients with severe heart, brain, lung and other organ diseases and vascular diseases, whose systemic conditions cannot tolerate surgery; (ii) combined with vertebral deformity; and (3) patients with incomplete clinical data.
General Information
The imaging data of AIS patients admitted from July 2019 to July 2022 were retrospectively analyzed, and a total of 24 AIS patients were included.
The patients' data were divided into the postural awareness group (n = 12 cases) and the C‐arm group (n = 12 cases) according to whether postural awareness surgical tool was used during the operation. All patients were given posterior spinal orthopedic surgery. The C‐arm group included six males and six females, with an average age of 14.67 ± 2.06 years (11–17 years). The mean follow‐up period was 15.17 ± 2.29 months (12–19 months). In the postural awareness group, there were four males and eight females, with an average age of 15.08 ± 2.71 years (10–19 years), and an average follow‐up of 16.17 ± 2.08 months (13–20 months). All patients in this study signed informed consent and were approved by the Ethics Committee of Henan Provincial People's Hospital, with ethical approval number (2022) New Ethics Review Technology (1‐233).
Introduction and Application of Postural Awareness Surgical Tool
The postural awareness surgical tool consists of two parts: the surgical approach cone with the attitude sensing information module and the corresponding APP software (WTAPP‐release). Among them, the surgical approach cone is a commonly used open cone instrument in orthopedic surgery. The interior of the attitude sensing information module is primarily composed of an integrated micro‐angle measurement sensor, while the exterior is made of airtight polymer materials. The module transmits information to the corresponding APP (WTAPP‐release) for display via Bluetooth. We completed its fabrication at the School of Mechanical and Automatic Control Engineering at Zhejiang Sci‐Tech University, and have also applied for a patent with the patent number ZL202010372918.4. Subsequently, we attach a container that can accommodate the attitude sensing information module to the surgical access cone, facilitating the placement of the module inside the container before the operation begins. Before the operation, the instrument is installed first, and after the reference plane is demarcated on the smart phone, the transverse angle and sagittal angle between the surgical cone and the reference plane can be displayed in real time, and the angle along the axis of the surgical cone can be displayed, as shown in Figure 1.
FIGURE 1.
(A) Is a schematic diagram illustrating the working principle of the postural awareness surgical tool. (B) Shows the posture perception information module, which is primarily composed of the integrated micro‐angle measurement sensor depicted in (A). (C) Depicts a surgical access cone that can accommodate the posture perception information module.
Surgical Procedure
Preoperative Preparation
The original DICOM CT data of the patient was downloaded from the PACS system of the hospital before surgery, and the layer thickness was 0.625 mm. Then the data was imported into Renaissance software for simulated nail placement. The surgeon selects the optimal placement position according to the reconstructed image in the software and simulates the screw placement required during the operation. The length, angle, position and model of the screw are adjusted to ensure that the pedicle nail path is the best placement path centered on the three‐dimensional plane of the screw, vertebral body and pedicle cross section, sagittal plane and coronal plane. Being careful not to break through the surrounding cortical structure, and finally record the length, diameter and angle of the screws (as shown in Figure 2A–F).
FIGURE 2.
The best placement path of pedicle screws in T11‐L4 vertebrae of patients was simulated by Renaissance software (A–F). (a–f) Shows the CT image of the patients 1 week after operation. Compared with the preoperative plan, the postoperative CT shows that the screw position is good, which is basically consistent with the screw angle designed before operation.
Intraoperative Procedure
After general anesthesia, the patient was placed in a prone position. After the surgical segment is determined by fluoroscopy, the surgical area is exposed. After exposure is complete, postural awareness surgical tool is prepared to be used. First, the attitude perception information module is installed into the surgical cone, and the aseptic membrane is pasted. During the operation, aseptic operation is paid attention to. Second, open the mobile phone software to connect the postural awareness surgical tool. The postural awareness surgical tool was placed parallel to the spine process of the target vertebral body, and the assistant was instructed to click the reference plane button on the software to calibrate the reference plane, and then click the angle reset button to zero the angle. Then, the postural awareness surgical tool was placed at the pre‐designed insertion point and adjusted to the pre‐designed angle, and the nail path was prepared (as shown in Figure 3A–D). After completion, the probe was used to probe the integrity of the surrounding wall of the nail path and the positioning needle was driven. Use the C‐arm perspective to confirm the proper location of the nailing path after all the nailing paths are completed using the same method. The pedicle screw is then inserted, adjusting the screw at any time during the process. After that, orthopedic and other operations were performed. The C‐arm group underwent traditional C‐arm guided orthopedic surgery (Figure 4).
FIGURE 3.
The procedure of using postural awareness surgical tool during operation: First of all, parallel the assembled postural awareness surgical tool to the spinous process of the patient (A), and ask the assistant to click the “Reference plane” button on the software, and then click the “Zero the Angle information” button (B). Put the postural awareness surgical tool after zero clearance to the entry point (C), then tilt the tool to the angle designed before operation, and begin to prepare the nail path (D).
FIGURE 4.
A 13‐year‐old female was admitted to hospital with the main complaint of “finding unequal height of both hips for more than 50 days.” The full‐length X‐ray of the spine showed that the Cobb angle of the main curve was 45.82°. After excluding contraindications for surgery, she was given general anesthesia and “posterior spinal orthopedic surgery assisted by postural awareness surgical tool.” There were no postoperative complications. One week after operation, the X‐ray showed that the Cobb angle of the main curve was 5.61°. The CT scan showed that the position of each pedicle screw was good, as shown in Figure 2. One year after operation, the X‐ray showed that the Cobb angle of the main bend was 6.53°.
Outcome Measures
Nailing Accuracy
According to the classification of Gertzbein–Robbins, 14 the implanted screws were classified. According to the classification of Gertzbein–Robbins: Grade A, the pedicle screws were in the pedicle; Grade B, pedicle screws penetrated the pedicle cortex ≤ 2 mm; Grade C, 2 mm < pedicle screw through the pedicle cortex ≤ 4 mm; Grade D, 4 mm < pedicle screw through the pedicle cortex ≤ 6 mm; Grade E, pedicle screws penetrated the pedicle cortex > 6 mm; Class A and B are regarded as accurate nail placement. Nail placement accuracy = (Number of class A + B screws)/total number of nails ×100%.
Duration of Surgery
Surgical time was defined as the time to complete all procedures after anesthesia, including patient positioning, exposure of the surgical area, pedicle screw insertion, orthosis, wound closure, and change of patient position.
Intraoperative Blood Loss
Intraoperative blood loss is defined as the amount of blood lost by the patient during surgery and is measured by the sum of the blood in the suction bottle and the blood in the gauze.
Radioscopic Frequency
Radioscopy was defined as the number of times C‐arm fluoroscopy was used from the beginning to the end of surgery.
Cobb Angle of Main Bend and Scoliosis Correction Rate
The Cobb angle is defined as a straight line drawn along the upper endplate of the upper vertebra and the lower endplate of the lower vertebra, the angle between the two lines or the angle of the intersection of their vertical lines. Scoliosis correction rate = (preoperative Cobb angle − postoperative Cobb angle)/preoperative Cobb angle × 100%.
All operations were performed by the same team of physicians, and the time of operation, amount of intraoperative blood loss and number of radioscopies were recorded by one surgeon after each operation. Cobb angle was measured on full length anterior‐lateral radiographs of the spine. 16‐slice spiral CT was used to evaluate screw accuracy. Measurements of Cobb angle and screw position grading were performed by two experienced spinal surgeons before surgery, 1 week and 1 year after surgery, and the results were averaged.
Statistical Analysis
Statistical software SPSS26.0 (IBM, Armonk, NY, USA) was used for comparative analysis of all data. Measurement data with normal distribution or approximate normal distribution were expressed by (± s). T‐test or rank sum tests were used for inter‐group and intra‐group comparisons. The comparison of count data was performed using the rank sum test and χ 2‐test, with α = 0.05 as the level of significance.
Results
General Information
A total of 24 AIS patients were included in this study, including 12 patients in the postural awareness group and 12 patients in the C‐arm group, six males and six females in the C‐arm group, with an average age of 14.67 ± 2.06 years (11–17 years) and an average follow‐up of 15.17 ± 2.29 months (12–19 months). In the postural awareness group, there were four males and eight females, with an average age of 15.08 ± 2.71 years (10–19 years), and an average follow‐up of 16.17 ± 2.08 months (13–20 months). There were no significant differences in sex, age and follow‐up time between the two groups (p > 0.05 Table 1).
TABLE 1.
Comparison of general data between the two groups.
| Basic information | C‐arm group | Postural awareness group | Test statistics | p‐value |
|---|---|---|---|---|
| Gender (male/female) | 6/6 | 4/8 | 0.686 | 0.408 |
| Age (years) | 14.67 ± 2.06 | 15.08 ± 2.71 | 0.424 | 0.676 |
| Follow‐up time (months) | 15.17 ± 2.29 | 16.17 ± 2.08 | 1.119 | 0.275 |
Surgery Related Indicators
The average operation time of each patient was 220.54 min, the intraoperative blood loss was 512.5 mL, and the number of radiographs was 23.17. The operation time of the C‐arm group was 236.33 ± 29.31 min, the amount of intraoperative blood loss was 545.83 ± 39.42 mL, the number of radioscopies was 23.58 ± 2.39, the operation time of the postural awareness group was 204.75 ± 37.38 min, and the amount of intraoperative blood loss was 479.17 ± 39.19 mL. The radioscopy times were 20.67 ± 2.71 times. It can be seen that the operation time (p = 0.031 < 0.05), intraoperative blood loss (p < 0.001) and fluoroscopy times (p = 0.011 < 0.05) of patients in the postural awareness group were smaller than those in the C‐arm group, and the differences were statistically significant (Table 2).
TABLE 2.
Comparison of surgery‐related indexes between the two groups.
| Observation indices | C‐arm group | Postural awareness group | Test statistics | p‐value |
|---|---|---|---|---|
| Operation time (min) | 236.33 ± 29.31 | 204.75 ± 37.38 | 2.303 | 0.031 |
| Amount of bleeding (mL) | 545.83 ± 39.42 | 479.17 ± 39.19 | 4.155 | <0.001 |
| Perspective frequency (time) | 23.58 ± 2.39 | 20.67 ± 2.71 | 2.797 | 0.011 |
Nail Placement Accuracy
Postoperative CT review was performed to evaluate the grade and accuracy of pedicle screw placement. The number of class A/B/C/D/E screws in the C‐arm group was 79/53/18/9/0, and the accuracy rate was 83.02% (132/159), while the number of class A/B/C/D/E screws in the postural awareness group was 93/56/10/4/0, respectively. The nail placement accuracy was 91.41% (149/163). In terms of nail placement accuracy, there was a significant difference in nail placement accuracy between the two groups (p = 0.025 < 0.05), and compared with the hands‐free group, the postural awareness surgical tool group had a significantly higher nail placement accuracy (Table 3).
TABLE 3.
Comparison of screw insertion accuracy between the two groups.
| Group | Grade A (pieces) | Grade B (pieces) | Grade C (pieces) | Grade D (pieces) | Ζ‐value | p‐value | Nailing accuracy (%) | χ 2‐value | p‐value |
|---|---|---|---|---|---|---|---|---|---|
| C‐arm group | 79 | 53 | 18 | 9 | 1.797 | 0.072 | 83.02 (132/159) | 5.102 | 0.024 |
| Postural awareness group | 93 | 56 | 10 | 4 | 91.41 (149/163) |
Comparison of the Patient's Main Curve Cobb Angle
There was no significant difference between the two groups of patients before surgery, 1 week after surgery, and 1 year after surgery (p > 0.05). There was no significant change in the Cobb angle of the two groups of patients at the 1‐year follow‐up compared with the 1‐week postoperative follow‐up (p > 0.05, Table 4), indicating that the correction effect was maintained well and there was no correction loss. There was no significant difference in the scoliosis correction rate between the two groups of patients at the 1‐week follow‐up and the 1‐year follow‐up, indicating that the correction effects of the postural awareness surgical tool assisted orthopedic surgery and manual orthopedics are similar (Table 5).
TABLE 4.
Comparison of Cobb angle of main curvature between the two groups before and after surgery.
| Grouping and Results | Before operation | 1 week after surgery | 1 year after surgery | 1 week after surgery versus 1 year after surgery | |
|---|---|---|---|---|---|
| Test statistics | p‐value | ||||
| C‐arm group | 55.10 ± 5.65 | 8.06 ± 1.99 | 9.50 ± 1.99 | 1.770 | 0.091 |
| Postural awareness group | 58.38 ± 4.43 | 9.24 ± 1.23 | 10.14 ± 1.98 | 1.338 | 0.194 |
| Test statistics | 1.580 | 1.742 | 0.787 | ||
| p‐value | 0.128 | 0.096 | 0.440 | ||
TABLE 5.
Comparison of scoliosis correction rates between the two groups.
| Grouping and Results | 1 week after surgery | 1 year after surgery | Test statistics | p‐value |
|---|---|---|---|---|
| C‐arm group | 85.33 ± 3.51 | 82.73 ± 3.27 | 1.875 | 0.074 |
| Postural awareness group | 84.13 ± 2.16 | 82.59 ± 3.44 | 1.309 | 0.204 |
| Test statistics | 1.010 | 0.103 | ||
| p‐value | 0.324 | 0.919 | ||
Discussion
Image navigation system includes traditional C‐arm X‐ray guidance, intraoperative CT navigation, ultrasonic navigation and intraoperative O‐arm navigation. 15 , 16 , 17 The computer assisted technology represented by O‐arm navigation is currently recognized as a more advanced technology with more clinical applications, and clinical data have proved that it has greatly improved the accuracy of nail placement and surgical efficiency. 18 , 19 However, the O‐arm navigation system uses a virtual real‐time image tracking technology. During the operation, the position of the reference frame will change relative to that of the patient due to the respiratory movement or the displacement or deformation of the spine, which will cause errors between the image and the real position, that is, image drift. Surgical robots mainly include robot system assisted nail placement and intelligent instrument assisted nail placement, mainly represented by Mazor and “Tian ji” robots. 20 , 21 Robot‐assisted screw placement can significantly improve the accuracy of screw placement, but due to the complexity of surgical techniques, the factors of surgical errors will increase, which may lead to postoperative complications, and the cost is high, which is difficult to be widely used. 22 In order to further improve the accuracy of pedicle nail placement and reduce intraoperative blood loss, our team independently developed a postural awareness surgical tool and initially applied clinically.
Evaluation of Safety, Effectiveness, and Accuracy of Postural Awareness Surgical Tool
The results of this study showed that compared with hands‐free nail placement, postural awareness surgical tool assisted nail placement could significantly reduce the amount of intraoperative blood loss, operative time and intraoperative fluoroscopy times (p < 0.05). In the comparison of imaging parameters, the Cobb angle of the main curve in the two groups was significantly lower than that before operation, and there was no significant difference in the follow‐up time after 1 year compared with that at 1 week after operation (p > 0.05). This shows that the two surgical methods can bring ideal clinical results for patients, and can maintain the orthopedic effect after at least 1 year. Therefore, in the case of the same clinical effect, postural awareness surgical tool can reduce the amount of intraoperative blood loss, operation time, reduce X‐ray use during operation, and reduce the exposure of surgeons. In terms of nail placement accuracy, there was significant difference between the two groups (p = 0.024). Compared with the C‐arm group, the nail placement accuracy in the postural awareness group was significantly higher than that in the C‐arm group (p = 0.024). The accuracy of screw placement was 83.02% in the C‐arm group and 91.41% in the postural awareness group. Compared with 85% of the screw placement accuracy under open surgery by Cui et al., posture sensing surgical tool assisted pedicle screw placement has the advantage of high accuracy. 14
Advantages of Postural Awareness Surgical Tool
The postural awareness surgical tool has the following advantages: first, it can provide the doctor with the information of the deviation angle of the instrument during the operation; second, the posture change of the surgical instrument can be sensed in real time during the preparation of the nail path, and it can be displayed to the surgeon in real time through the mobile phone software. Third, adjusting the posture of the surgical instruments according to the feedback information can ensure that the preparation of the screw canal is completely carried out in the pedicle cancellous bone canal without breaking through the pedicle cortical bone, so as to avoid the occurrence of screw misplacement; fourth, the accurate positioning of the surgical tool in the operation can reduce the amount of blood loss during the operation, shorten the operation time and reduce the exposure of the surgeon.
Use Experience and Precautions
However, the following aspects should be paid attention to when applying posture sensing surgical tools. First, before using the spinous process as a reference plane, it is necessary to zero the reference plane and make the reference plane and basic parameters return to zero. If the spinous process is seriously deformed and is not suitable to be used as a reference plane, the reference plane can be set after the spinous process is removed. If the basic parameters of the software cannot be zeroed before the operation, or the error of the reference plane is large, there will be a certain error in the angle of the screw during the operation. Second, attention should be paid to aseptic operation when assembling the core module to avoid polluting the operation area due to improper operation. Third, after pedicle screw placement, it needs to be verified by fluoroscopy many times, which will still have a certain degree of radiation.
Limitation and Strengths
This study compared the application of C‐arm‐guided assisted nailing and postural awareness surgical tool assisted nailing in orthopedic surgery for adolescent idiopathic scoliosis patients, and explored the safety, accuracy, and effectiveness of postural awareness surgical tool. In addition, the advantages and precautions in application of postural awareness surgical tool were analyzed based on clinical experience. However, there are still some limitations in this study. First, our study is a single‐center, small‐sample study, and the results may be biased. Second, the follow‐up time is relatively short, and long‐term follow‐up is needed to evaluate the efficacy. Many potential advantages or problems still need to be further verified through large samples and sufficient time.
Conclusion
The application of the postural awareness surgical tool in posterior correction of adolescent idiopathic scoliosis can improve the accuracy of screw placement and shorten the time of screw placement. Compared with manual screw placement assisted by X‐ray, pedicle screw placement assisted by the postural awareness surgical tool is safer and more accurate.
Conflict of Interest Statement
The authors have no conflict of interest to disclose.
Ethics Statement
This study complies with the principles of the Helsinki Declaration. It has been approved by the Clinical Trial Ethics Committee of Henan Provincial People's Hospital, with approval number (2022) New Ethics Review Technology (1‐233). This study has obtained written informed consent from all parents.
Author Contributions
All authors have full access to the data in the study and are responsible for the integrity of the data and the accuracy of the data analysis. Experimental design and surgical operation: Shi Xinge, Gao Yanzheng, Hu Weiran; data collection and analysis: Wu Xiaonan, Wang Haoxu, Ma Haohao; manuscript drafting: Wu Xiaonan, Jiang Zhengfa; revision of important content: Shi Xinge; and statistical analysis: Hu Weiran, Wu Xiaonan.
Funding Information
This study was supported by the key project of the joint construction of medical science and technology in Henan Province (SBGJ202102024).
Acknowledgments
We wish to thank all patients who generously agreed to participate in this study. This study was supported by the key project of the joint construction of medical science and technology in Henan Province (SBGJ202102024).
XiaoNan Wu and Xinge Shi contributed equally to this study and should be considered co‐first author.
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