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. 2023 Feb 13;15(4):993–1001. doi: 10.1111/os.13670

Unilateral Percutaneous Kyphoplasty Using a Novel Guide Device for Thoracolumbar Osteoporotic Vertebral Fracture

Hongwei Wang 1, Hailong Yu 1, Yunpeng Zhu 2, Hongwen Gu 1, Bin Zheng 1, Yuanhang Zhao 1, Wenfeng Han 1,✉, Liangbi Xiang 1,✉
PMCID: PMC10102313  PMID: 36782345

Abstract

Objectives

Unilateral percutaneous kyphoplasty (UPKP) has been effective in reducing the operative time, cement volume, and cement leakage (CL) rate compared with bilateral kyphoplasty. However, no device can help to determine the trajectory during operation, especially the inner inclination angle. To assess the safety and efficacy of a novel guide device (GD) for UPKP in the treatment of thoracolumbar osteoporotic vertebral fractures (TLOVFs).

Methods

From January 2019 to May 2021, 31 patients diagnosed with single TLOVF who underwent UPKP were retrospectively reviewed. The patients were divided into two groups: traditional UPKP (UPKP group, 15 patients) and UPKP assisted with GD (UPKP‐GD group, 16 patients). Pre‐procedure demographic, clinical and radiologic characteristics, operative procedure details, and clinical and radiologic outcomes at 1 day and 12 months post‐procedure were collected. Statistical analyses were carried out using SPSS 24.0. The baseline characteristics of the two groups were compared by the independent sample t test or the χ 2 test. The anterior height or local kyphotic angle (LKA) of the fractured vertebrae, visual analog scale (VAS) score, and Oswestry Disability Index (ODI) within groups were compared using the paired t test.

Results

A total of 31 patients (five men and 26 women; age range: 58–90 years) completed the full 12‐month postoperative follow‐up schedule. No significant differences were observed between treatment groups with respect to sex, age, body mass index, preoperative bone mineral density, or surgical level. Compared with the UPKP group, the operation time in the UPKP‐GD group was significantly shorter (40.8 ± 5.5 min vs. 48.5 ± 8.5 min, p = 0.005), and the number of intraoperative fluoroscopy times in the UPKP‐GD group was significantly decreased (20.6 ± 4.5 vs. 25.2 ± 2.4, p = 0.001). Five (31.3%) patients in the UPKP‐GD group and four (26.7%) patients in the UPKP group had bone CL. The VAS and ODI scores, anterior height and LKA of the fractured vertebrae were significantly improved after surgery in each group. No significant differences in postoperative VAS and ODI scores, anterior height or LKA of the fractured vertebrae, volume of injected cement or CL were observed between the two groups.

Conclusion

Unilateral puncture using a novel GD is a safe and effective technique for patients with TLFs and UPKP assisted with a novel GD is associated with fewer intraoperative fluoroscopy times and shorter operation time.

Keywords: Guide Device, Percutaneous Kyphoplasty, Thoracolumbar Osteoporotic Vertebral Fracture, Unilateral

Unilateral puncture using a novel guide device is a safe and effective technique for patients with TLFs and UPKP assisted with a novel guide device is associated with fewer intraoperative fluoroscopy times and shorter operation time.

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Introduction

Fractures of the thoracolumbar spine represent 42.4%–75.2% of all spinal fractures, followed by lumbar and cervical spine fractures. 1 , 2 , 3 , 4 Thoracolumbar osteoporotic vertebral fractures (TLOVFs) are the most common complication of osteoporosis and can not only affect patients' work and daily life but also lead to other functional disorders, spinal deformities, and sometimes even paralysis. 5 , 6 , 7 , 8

Percutaneous kyphoplasty (PKP) is a rapid, effective, and minimally invasive technique for treating TLOVFs in elderly patients, and it can speed recovery of function and improve quality of life with fewer complications compared with conservative treatment. 9 , 10 , 11 , 12 , 13 However, surgeons are heavily dependent on image‐guided navigation, especially when the surgeon is inexperienced. The radiation dose of the operator was highest in C‐arm‐guided minimally invasive spine surgery. The protection of operators from radiation exposure and avoidance of iatrogenic radiation‐induced injuries are high priorities in the introduction of new operative techniques. 14 Various recommendations for different combinations of radiation‐shielding devices have been proposed. 15 However, these shielding devices are usually very heavy, and strenuous for surgeons to wear for long periods.

Currently, the standard technique for kyphoplasty is the bilateral approach. However, the unilateral approach has also been effective in reducing the operative time, cement volume, and cement leakage (CL) rate compared with bilateral kyphoplasty. Therefore, we maintain that unilateral kyphoplasty is more advantageous with respect to both effectiveness and safety than bilateral kyphoplasty for the treatment of osteoporotic vertebral compression fractures (OVCFs). 16 The modified unilateral extrapedicular approach PKP could be clinically and radiographically equivalent to the bilateral transpedicular approach PKP. However, it has advantages in reducing operation time and fluoroscopy times, lowering the risk of intraspinal CL, and preventing the presence of facet joint violation. 17 Unilateral PKP (UPKP) would be an attractive alternative to traditional bilateral PKP owing to a lower radiation dose, shorter operation time, and fewer complications. 16 , 17 , 18

A method to further reduce the radiation dose would be of great value for unilateral puncture. Previous researchers have pointed out that the insertion time and radiation exposure can be significantly reduced by using an intradermal locator. 19 , 20 However, an intradermal locator cannot help to determine the trajectory, especially the inner inclination angle. Therefore, we invented a novel guide device (GD) (National Invention Patent, ZL201610038122.9) and manufactured it using 3D printing technology. The objective of the current study was to (i) assess the efficacy and safety of UPKP using the novel GD versus traditional UPKP for the treatment of TLOVFs; (ii) to compare the surgery outcomes, clinical outcomes, and radiographic outcomes at 1 day and 12 months post‐procedure; and (iii) to assess the technical characteristics and advantages of the novel GD.

Methods

Patients

We performed a retrospective analysis of data from patients with single‐level TLOVF treated with unilateral PKP from January 2019 to May 2021. The patients were divided into two groups according to the surgical technique used: traditional unilateral PKP (UPKP group, 15 patients) and unilateral PKP assisted with GD (UPKP‐GD group, 16 patients). Pre‐procedure demographic, clinical and radiologic characteristics, operative procedure details, and clinical and radiologic outcomes at 1 day and 12 months post‐procedure were collected.

The inclusion criteria included the following: (1) a single‐level fracture in the thoracolumbar vertebra (T11–L2) identified through preoperative radiological findings and tapping pain at the spinal process of the fractured vertebral body; (2) preoperative pain over 5, measured by a visual analog scale (VAS); (3) a new fracture without any previous fractures of the vertebrae through preoperative radiological findings; (4) a T value ≤−2.5 in a bone mineral density (BMD) examination of the lumbar vertebra; and (5) an intact vertebral posterior wall. The exclusion criteria included (1) a history of previous vertebral augmentation; (2) a pathological fracture caused by a tumor or spine infection; and (3) comorbidities involving thyroid dysfunction. Preoperative, 1‐day postoperative, and 12‐month postoperative VAS scores and Oswestry Disability Index (ODI) indices were obtained from the patients using structured questionnaires administered by orthopaedic residents who were blinded to our grouping of patients. X‐rays or CT or MRI were taken preoperatively, 1 day postoperatively, and 12 months postoperatively by a radiologist who was blinded to our grouping of patients. The study protocol was approved by the ethics committee of the General Hospital of the Northern Theater Command, and informed consent was obtained from all patients (Y‐2021‐025).

Device Composition

The 3D‐printed GD includes a puncture needle or Kirschner wire (Figure 1A), an intradermal locator (Figure 1B), and an angle measuring device (Figure 1C). The intradermal locator, which is 10 cm in length and 0.8 cm in diameter, is a bullet‐shaped device with four channels of approximately 0.2 cm each. The diameter of each channel is slightly larger than that of a Kirschner wire (Figure 1B). The angle measuring device includes a semicircle mold with an angular scale and a bone cement ball with silk thread (Figure 1C). The operator can deflect the GD and observe the deflecting angle through the angle measuring device (Figure 1D,E). The intradermal locator and angle measuring device was created by reverse engineering and rapid prototyping techniques (Figure 2A–C). The 3D printed GD can be used repeatedly after sterilization with ethylene oxide.

FIGURE 1.

FIGURE 1

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Design drawing of guide device (GD). (A) The puncture needle or Kirschner wire. (B) The intradermal locator. (C) The angle measuring device. (D,E) We deflect the GD, and meanwhile we can observe the deflecting angle through the angle measuring device

FIGURE 2.

FIGURE 2

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Guide device (GD). (A) Computer graphic design of the GD, including the intradermal locator and the angle measuring device. (B) The GD produced by 3D printing technology. (C–F) Intraoperative imaging data showing the performance of PKP using a 3D printed GD. PKP, percutaneous kyphoplasty

Surgical Procedures

The entry point and trajectory were designed through preoperative three‐dimensional CT scans, and the entry point and inner inclination angle of the trajectory were recorded. 21 , 22 The patient was placed in the prone position. We ensured that the spinous process was located in the middle of the line between both projections of the pedicles. After disinfection, dressing, and local anesthesia, the Kirschner wire was percutaneously inserted to dock at the approximate position of the lateral margin of the facet joint, and then the intradermal locator was placed along the Kirschner wire (Figure 2D). Then, we inserted other Kirschner wires through the channels of the 3D printed GD (Figure 2E). The Kirschner wire with the best location was chosen and left after anteroposterior and lateral fluoroscopy. Then, we deflected the GD and inserted the Kirschner wire into the body according to the preoperative inner inclination angle of the trajectory, which could be observed on the angle measuring device intraoperatively (Figure 2F). Then, a dilated cannula and a working cannula were inserted to establish the working passage. Subsequent procedural processes were the same as for traditional PKP surgery.

Outcome Measures

Data pertaining to patient age, sex, body mass index (BMI), BMD (T score), volume of injected cement, fracture level, operation time, intraoperative blood loss, intraoperative fluoroscopy times, hospital stay, and hospitalization cost were collected and reviewed. Preoperative, 1‐day postoperative, and 12‐month postoperative VAS scores and ODI indices were compared. X‐rays or CT were taken preoperatively, 1 day postoperatively, and 12 months postoperatively. The images were reviewed for CL, anterior height of the fractured vertebrae (AVH), and the local kyphotic angle (LKA) of the fractured vertebrae as well as the extent of reduction and correction. Illustrated cases are shown in Figures 3 and 4.

FIGURE 3.

FIGURE 3

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The imaging data of a 75‐year‐old woman showed L2 vertebral compression fracture treated through unilateral PKP. (A,B) Preoperative lumbar radiograph; (C,D) 1‐day postoperative lumbar radiograph after unilateral PKP; (E,F) 12‐month postoperative lumbar radiograph after PKP. PKP, percutaneous kyphoplasty

FIGURE 4.

FIGURE 4

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The imaging data of typical cases treated through unilateral PKP. (A–C) Patient with a L1 fracture treated with unilateral PKP; (D–F) Patient with a T12 fracture treated with unilateral PKP. PKP, percutaneous kyphoplasty

Statistical Analysis

Statistical analyses were carried out using SPSS 24.0 (IBM Corporation, Armonk, NY). Nominal variables were expressed as numbers (percentage). The baseline characteristics of the two groups were compared by the independent sample t test or the χ 2 test. The AVH, LKA, VAS score, and ODI within groups were compared using the paired t test. The significance level was set to 0.05.

Results

General Information and Surgery Outcomes Comparison

The overall mean age was 69.0 ± 9.2 years (51–90 years). No significant differences were observed with respect to sex, age, BMI, preoperative bone mineral density, surgical level, preoperative VAS, ODI, AVH, or LKA or the mean follow‐up duration between the two groups. Surgery was successful in all patients, and none of the patients experienced lower‐limb deep venous thrombosis, pulmonary embolism, or spinal nerve injury. Compared with the UPKP group, the operation time in the UPKP‐GD group was significantly shorter (40.8 ± 5.5 min vs. 48.5 ± 8.5 min, p = 0.005), and the number of intraoperative fluoroscopy times in the UPKP‐GD group was significantly decreased (20.6 ± 4.5 vs. 25.2 ± 2.4, p = 0.001). There were no significant differences between the two groups in terms of intraoperative blood loss, hospital stay, or hospitalization cost (Table 1).

TABLE 1.

Comparison of the characteristics and surgery parameters of the patients between the two groups

Characteristic UPKP (n = 15) UPKP‐GD (n = 16) t/χ 2 value p value
Male/female 3/12 2/14 0.006 0.937
Mean age (years) 69.3 ± 6.9 67.9 ± 10.3 0.439 0.664
BMI (kg/m2) 23.2 ± 2.9 24.0 ± 2.7 −0.725 0.474
BMD −3.0 ± 0.3 −3.0 ± 0.4 −0.547 0.588
Fractured vertebrae
T11 1 1 2.146 0.543
T12 4 4
L1 9 7
L2 1 4
Mean follow‐up duration (m) 25.8 ± 10.5 21.4 ± 7.0 1.376 0.181
Operation time (min) 48.5 ± 8.5 40.8 ± 5.5 3.034 0.005
Intraoperative blood loss (ml) 8.3 ± 2.4 8.6 ± 3.7 −0.202 0.841
Intraoperative fluoroscopy times 25.2 ± 2.4 20.6 ± 4.5 3.628 0.001
The volume of injected cement (ml) 3.7 ± 0.8 4.0 ± 0.7 −1.236 0.226
Postoperative hospital stay (days) 2.2 ± 1.7 1.4 ± 1.0 1.655 0.111
Total hospital stay (days) 4.1 ± 1.7 3.8 ± 2.0 0.479 0.635
Total hospitalization cost (CNY) 34218.7 ± 4542.1 34758.4 ± 2090.0 −0.430 0.671
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Abbreviations: BMD, bone mineral density; BMI, body mass index; GD, guide device; UPKP, unilateral percutaneous kyphoplasty.

Comparison of Clinical Outcomes

Within each treatment group, the VAS and ODI scores were significantly lower at 1 day after surgery relative to preoperative scores. There were no significant differences in postoperative VAS or ODI scores between the two groups (Table 2).

TABLE 2.

Comparison of the clinical and radiographic parameters for each group before and after surgery

Characteristic UPKP (n = 15) UPKP‐GD (n = 16) t/χ 2 value p value
VAS score
Preoperative 7.3 ± 0.8 7.5 ± 0.9 −0.764 0.451
1 day postoperative 3.1 ± 0.5 3.4 ± 0.5 −1.792 0.084
Improvement 4.2 ± 0.9 4.1 ± 0.7 0.264 0.794
12 months postoperative 1.8 ± 0.4 1.9 ± 0.5 −0.453 0.654
ODI
Preoperative 73.9 ± 5.7 74.0 ± 10.0 −0.045 0.964
1 day postoperative 33.5 ± 5.6 35.5 ± 7.2 −0.868 0.392
Improvement 40.4 ± 1.4 38.5 ± 4.4 1.663 0.114
12 months postoperative 15.6 ± 2.8 15.6 ± 3.4 −0.022 0.982
AVH (mm)
Preoperative 20.7 ± 6.5 21.7 ± 4.6 −0.514 0.611
1 day postoperative 26.2 ± 6.1 28.3 ± 5.2 −0.997 0.327
Improvement 5.6 ± 3.2 6.6 ± 3.7 −0.793 0.434
12 months postoperative 24.7 ± 5.6 27.3 ± 5.8 −1.304 0.202
LKA (°)
Preoperative 13.4 ± 4.1 12.9 ± 5.0 0.302 0.765
1 day postoperative 8.3 ± 3.2 7.7 ± 3.5 0.469 0.643
Improvement 5.1 ± 2.8 5.2 ± 2.5 −0.073 0.942
12 months postoperative 8.8 ± 3.3 9.6 ± 4.2 −0.580 0.566
Cement leakage (n) 4 (26.7%) 5 (31.3%) 0.000 1.000
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Abbreviations: AVH, anterior height of the fractured vertebrae; GD, guide device; LKA, local kyphotic angle; ODI, Oswestry Disability Index; UPKP, unilateral percutaneous kyphoplasty; VAS, visual analog scale.

Comparison of Radiographic Outcomes

The AVH and LKA were significantly improved from preoperative levels at both 1 day and 12 months postoperative. Five (31.3%) patients in the UPKP‐GD group and four (26.7%) patients in the UPKP group had CL. There were no significant differences in postoperative AVH or LKA of the fractured vertebrae, volume of injected cement, or the occurrence of CL between the two groups (Table 2).

Discussion

Safety and Efficacy of a Novel Guide Device for Unilateral Percutaneous Kyphoplasty in the Treatment of Thoracolumbar Osteoporotic Vertebral Fractures

During percutaneous kyphoplasty, repeated fluoroscopies to adjust the puncture needle and inject the cement are often required. Thus, a method to reduce radiation exposure while maintaining accurate puncture needle insertion and safe cement injection would be of great value. Our results demonstrate the efficacy and safety of an innovative 3D printed GD for UPKP with the advantage of fewer fluoroscopy applications. There was no significant difference in pain relief or functional improvement between the UPKP‐GD group and the UPKP group, however the operation time and intraoperative fluoroscopy times were significantly reduced in the UPKP‐GD group compared with the UPKP group. In the current study, a significant improvement in the VAS, ODI, AH, and LKA was observed after treatment in both groups with no significant differences between groups. UPKP had the ability to restore the vertebral height and improve vertebral alignment, which was consistent with previous studies. 16 , 17 , 18 The advantages of UPKP assisted with GD over traditional UPKP for the treatment of TLFs are derived from the need for fewer intraoperative fluoroscopy times and shorter operation duration with no increase in the rate of CL.

Surgery Outcomes and Clinical Outcomes Comparisons

Thoracolumbar osteoporotic vertebral fractures are the most common complication of osteoporosis, and can lead to chronic pain, height loss, and impaired activities of daily living, an increased risk of pressure sores, pneumonia, and psychological distress. Patients with an acute TLOVF may report abrupt onset of back pain with position changes, coughing, sneezing, or lifting. 23 In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, sustained for at least 1 year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. 24 Compared with conservative treatment, percutaneous vertebroplasty provides a rapid decrease in pain and an early return to daily life activities. 25 , 26 In the current study, 80.6% (25/31) of the patients chose operation within 1 month after injury, and only 19.4% (6/31) of patients chose operation more than 1 month after injury due to consistent unbearable physical pain with conservative treatment, but there were no neurological deficits. Compared with the UPKP group, the operation time in the UPKP‐GD group was significantly shorter, and the number of intraoperative fluoroscopy times in the UPKP‐GD group was significantly decreased. The VAS and ODI scores were significantly improved after surgery in each group. No significant differences in postoperative VAS and ODI scores were observed between the two groups. All patients experienced a rapid decrease in pain and an early return to daily life activities after percutaneous kyphoplasty.

Radiographic Outcomes and Complications Comparisons

A major complication during PKP is CL, which may cause serious consequences, such as embolism of distal organs or local chemical or compression symptoms. 27 , 28 OCVFs are usually associated with breakage of the peripheral vertebral wall, which is thought to increase the risk of CL during surgery. 29 , 30 In OCVFs with compromised vertebral body walls, the risk seemed to be higher, as surgical maneuvers may further aggravate cortical fragments. The integrity of the vertebral walls and the volume of injected cement have been associated with a significant increase in the risk of CL. 31 The incidence of CL after PKP for OVCFs has been reported to be as high as 50%. 32 , 33 Our study found that 29.0% (9/31) of patients suffered CL. Five (31.3%) patients in the UPKP‐GD group and four (26.7%) patients in the UPKP group had bone CL. The bone cement can leak from vertebral body deficiencies and fractures of the cortex, or through the vertebral venous system, and it is therefore crucial for clinicians to pay close attention to cortical defects in order to minimize the risk of leakage. If any bone cement leaks are noted during the operation, bone cement injection should be terminated immediately. 34

Bone cement distribution is associated with the anterior vertebral height restoration rate and bone cement volume, as well as the risk of bone cement extravasation. Greater bone cement distribution may indicate better vertebral restoration along with a higher bone cement extravasation risk. 35 A higher incidence of bone CL has been observed in patients with treated vertebrae exhibiting a single‐dispersive or single‐compact pattern. 36 In the current study, the incidence of CL was 31.3% in the UPKP‐GD group and 26.7% in the UPKP group, similar to results from a previous report. 32 , 33 The anterior height and LKA of the fractured vertebrae were significantly improved after surgery in each group. Operators should stop or slow down bone cement injection when the cement diffuses to the posterior margin of the vertebral body to avoid intraspinal leakage and pedicle diffusion, especially for patients with rupture of the medial wall of the pedicle caused by adjusting the puncture trajectory several times. The volume of cement injected and the distribution of the cement should also be carefully monitored to avoid bone CL.

Technical Characteristics and Advantages of the Novel Guide Device

The 3D printed GD, including the intradermal locator and angle measuring device, was used to accurately determine the entry point and angle of trajectory. During PKP, the conventional methods used for the Jamshidi needle and the advancement of the guidewire into the pedicle require numerous radiographic images. With the help of our novel intradermal locator, the Kirschner wire with the best bony puncture point was easily detected through a small incision using fluoroscopic images, and thus, the PKP working cannula could be accurately placed along the Kirschner wire to achieve the best location. After determination of the bony puncture point, the angle of the puncture trajectory could be adjusted using the angle measuring device, and repeated fluoroscopy to determine the relationship between the needle and the pedicle was avoided.

Strengths and Limitations

The study has some limitations: (1) it is a retrospective, single‐center study. Due to the strict inclusion criteria, the number of patients was relatively small, and the small sample size may lead to missing significant differences that may exist between the population of patients 37 ; (2) the follow‐up time was short, and the evaluation was not comprehensive, especially in terms of refracture after surgery, and selection bias might also lead to the deviation of results; (3) we used the fluoroscopy time as an indirect measure of radiation dose which may not yield an accurate estimate; however it has been used in prior studies and thus has some comparative value. 38 , 39 In spite of the above limitations, the safety and efficacy of this GD were elaborated in detail, which provided a preliminary study for clinical application. Future research examining the potential advantages of this new surgical technique, involving a larger sample of patients with longer follow‐up times, will aim to address these limitations.

Conclusions

Unilateral percutaneous kyphoplasty using a novel GD is a safe and effective technique for patients with TLFs, which presented with significantly improved VAS and ODI scores, anterior height and LKA of the fractured vertebrae after surgery, and UPKP assisted with a novel GD is associated with fewer intraoperative fluoroscopy times and shorter operation time. With the help of our novel GD, the best bony puncture point and the puncture trajectory was easily detected, and repeated fluoroscopy to determine the relationship between the needle and the pedicle was avoided.

Author Contributions

Hongwei Wang, Hailong Yu, and Yunpeng Zhu: Conceptualization, methodology, software, data curation, writing—reviewing and editing. Hongwen Gu, Bin Zheng, and Yuanhang Zhao: Formal analysis, software, writing—original draft preparation. Wenfeng Han and Liangbi Xiang: Formal analysis, software, supervision, writing—reviewing and editing.

Ethics Statement

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Acknowledgments

All listed authors have made substantial contributions to the manuscript and do not have any conflict of interest.

Hongwei Wang, Hailong Yu and Yunpeng Zhu contributed equally to this work.

Grant Sources: This work was supported by the Shenyang Science and Technology Project (21‐173‐9‐70, 22‐321‐33‐35) and Applied Basic Research Project of Liaoning Province (2022JH2/101300024).

Disclosure: All authors listed meet the authorship criteria according to the latest guidelines of the International Committee of Medical Journal Editors, and all authors are in agreement with the manuscript.

Contributor Information

Wenfeng Han, Email: hanwenfeng1977@163.com.

Liangbi Xiang, Email: xiangliangbi1963@163.com.

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