Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures With or Without Trauma

doi:10.21203/rs.3.rs-2617102/v1

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Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures With or Without Trauma

https://doi.org/10.21203/rs.3.rs-2617102/v1

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(1) Background: The study aims to compare the efficacy of percutaneous kyphoplasty (PKP) in the treatment of osteoporotic vertebral compression fractures (OVCFs) with or without trauma.

(2) Methods: Patients with OVCFs who have been treated with PKP from January 2020 to September 2020 were retrospectively analyzed and divided into trauma and non-trauma groups according to whether they had a clear history of trauma before onset. Before and after surgery, the two groups' oswestry dysfunction index (ODI), visual pain simulation score (VAS), vertebral kyphosis angle (Cobb angle), anterior height of damaged vertebrae, middle height of damaged vertebra, the rate of restoration of the damaged vertebra's anterior height, the rate of restoration of the damaged vertebra's middle height, and bone cement leakage rate were compared.

(3) Results: There were several significant differences in VAS or ODI scores between the two groups before , immediately after, and one year after surgery (p> 0.05). The Cobb angle and the rate of bone cement leakage were significantly lower in the non-trauma group compared to the trauma group (p< 0.05).

(4) Conclusion: Compared to patients with OVCF without trauma, patients with OVCF with trauma undergoing PKP surgery have a relatively high bone cement leakage rate, and the degree of Cobb angle recovery and the correction degree of vertebral kyphosis deformity are relatively good.

Osteoporotic

Vertebral compression fracture

Percutaneous kyphoplasty

Trauma

Bone cement leakage

Treatment effect.

The incidence of osteoporosis is rising worldwide, on this basis, the incidence of osteoporotic vertebral compression fracture (OVCF) is increasing. OVCF is a common disease in middle-aged and elderly people and is one of the most serious complications of osteoporosis¹. In recent years, the study of OVCFs has advanced, and PKP has become a common procedure for the treatment of OVCFs². Years of studies have proven that PKP surgery can effectively reconstruct the height of damaged vertebra and relieve pain; as long as the procedures are conducted, it is a safe, effective and simple treatment³. With increasing life expectancy, the proportion of older people has increased, and the number of patients with OVCFs without trauma has also increased. However, there are no studies comparing the efficacy of PKP surgery in the treatment of OVCFs with or without traumatic factors.

In this study, the curative effect of PKP surgery in treating OVCFs with or without trauma was retrospectively analyzed, providing references for future treatment.

2.1. General Data: This retrospective study was conducted on patients with OVCFs who have been treated with PKP surgery from January 2020 to September 2020. The patients with definite external injuries were divided into the trauma group, and those without external injuries were divided into the non-trauma group. The mean age and gender composition ratio of patients in the two groups were similar. Inclusion criteria: Patients who met the diagnostic criteria of Guidelines for Diagnosis, Preoperative X-ray, CT and MRI have been completed, and there are indications for PKP surgery, belonging to type 3, 4 or 5 in the OF classification⁴, the duration of the disease was less than 1 week from the beginning of the disease to surgery, Prevention and Management of Osteoporosis and those with complete medical records. Exclusion criteria: Patients have a history of past surgeries on the damaged vertebra; combined tumors, or tuberculosis.

2.2. Surgery and Methods: 1. After successful general anesthesia, the patient was positioned prone and routine disinfection; 2. After positioning the puncture point with a C-arm machine, the puncture needle was gently hammered into the patient's damaged vertebral body, and the working channel was then inserted into the vertebral body through a guide wire; 3. The balloon was inserted into the working channel and expanded under pressure. Following preparation, the bone cement was progressively put in. The working channel was removed when fluoroscopy revealed that the bone cement was uniformly dispersed in the damaged vertebral body; 4. Iodine was used to scrub the incision skin, followed by conventional dressing; 5. After the surgery, the patient was guided for functional exercise and was ordered to actively conduct anti-osteoporosis treatment and regular review in the Outpatient Clinic.

2.3. Observation indices: The preoperative and postoperative Cobb angle (The angle formed by the top edge of the damaged vertebra's upper vertebral body and the lower edge of the damaged vertebra's lower vertebral body), anterior height of damaged vertebrae (the height measured between the highest and lowest points of the anterior border of the damaged vertebrae, the same below), middle height of damaged vertebrae, the rate of restoration of the anterior edge of damaged vertebrae, the rate of restoration of the middle height of damaged vertebrae, and the bone cement leakage rate were compared in patients of the two groups(Examples of cases are shown in Figs. 1 and Figs. 2). The ODI and VAS score before, after and one year after surgery were compared between the two groups.

2.4. Statistical methods: All data were analyzed by SPSS 20.00 statistical software, and measurement data was reported as“‾x ± s ”. Univariate analysis was conducted with an independent sample t test. The bone cement leakage rate between the two groups was compared by χ² test, and p < 0.05 denoted a statistically significant difference.

In this study, 85 patients meeting the criteria were included, of whom 58 patients with a trauma history were classified into the trauma group, and 27 patients without a trauma history were classified into the non-trauma group. There were no statistically significant differences between the two groups in terms of mean age, sex composition ratio, preoperative VAS score, ODI index, anterior height, or middle height of the damaged vertebrae (Table 1). The patients in both groups received the identical PKP surgery, and there were no obvious vascular or nerve injuries, pulmonary embolisms or other significant complications during or after the surgery. All patients underwent anti-osteoporosis treatment and regular review after the surgery, followed by 1 year of follow-up.

Table 1

The patient's general clinical features
	Trauma group	Nontrauma group
n	58	27
Age^*	68.21 ± 7.84	70.29 ± 8.48
Gender ratio	10:48	4:23
VAS (Preoperative)^*	5.36 ± 0.91	5.22 ± 1.01
ODI (Preoperative)^*	44.78 ± 1.13	44.63 ± 1.08
Ha (Preoperative)^*	22.04 ± 4.37	22.43 ± 5.06
Hm (Preoperative)^*	18.92 ± 3.97	19.05 ± 4.29
Note: * Comparison of corresponding data from the two groups, p > 0.05

3.1. Postoperative clinical symptoms were improved in both groups, as shown in Table 2, Fig. 3 and Fig. 4. The VAS score and ODI index were greatly improved on the day of surgery and during one year of follow-up (p < 0.05). There was, however, no statistically significant difference between the two groups (p > 0.05).

Table 2

VAS score and ODI before, immediately after and one year after the surgery
	Preoperative		Postoperative
	With trauma	Without trauma	With trauma	Without trauma	With trauma	Without trauma
VAS	5.36 ± 0.91^a	5.22 ± 1.01	1.57 ± 0.50^ab	1.48 ± 0.51^b	1.38 ± 0.49^ab	1.37 ± 0.49^b
ODI	44.78 ± 1.13^a	44.63 ± 1.08	25.36 ± 1.58^ab	24.44 ± 1.09^b	21.24 ± 1.26^ab	20.63 ± 0.97^b
Note: a Comparison of corresponding data from the two groups, p > 0.05;

b Comparison of preoperative and postoperative within each group, p < 0.05

3.2. The anterior and middle heights of the damaged vertebrae in both groups were effectively recovered following surgery, according to postoperative imaging evaluation (p < 0.05). Nevertheless, very little statistically significant differences in the damaged vertebra’s middle and anterior height or the rate of restoration of the damaged vertebra’s middle and anterior height following surgery were found between the two groups (p > 0.05), as shown in Tables 3 and 4. The degree of spinal kyphosis correction (Cobb) between the two groups, on the other hand, was considerably different (p < 0.05), and the correction degree of kyphosis in the trauma group was slightly better than that in the non-trauma group.

Table 3

Ha and Hm before and after the surgery
	Preoperative		Postoperative
	With trauma	Without trauma	With trauma	Without trauma
Ha	22.04 ± 4.37	22.43 ± 5.06	27.15 ± 3.21^ab	26.32 ± 4.24^b
Hm	18.92 ± 3.97	19.05 ± 4.29	23.77 ± 3.00^ab	23.42 ± 3.87^b
Note: a Comparison of corresponding data from the two groups, p > 0.05;

b Comparison of preoperative and postoperative within each group, p < 0.05

Table 4

Comparison of the the rate of restoration of vertebral height and vertebral kyphosis correction between the two groups after surgery
	With trauma	Without trauma
Ha recovery rate (%)	19.10 ± 10.73^a	15.45%±9.21
Hm recovery rate (%)	20.78%±11.07^a	18.65%±11.66
Variation value of Cobb angle (°)	4.62 ± 2.98^b	2.96 ± 2.18
Note: a Comparison of corresponding data from the two groups, p > 0.05;

b Comparison of corresponding data from the two groups, p < 0.05;

3.3. There were no obvious bone cement leakage symptoms during or after the surgery in either group. There was, although, a substantial difference in the rate of bone cement leakage between the two groups (p < 0.05), as shown in Table 5.

Table 5

Comparison of the bone cement leakage rate in the two groups
	With trauma	Without trauma
With leakage	25	5
Without leakage	33	22
Note: χ2 = 4.876, p < 0.05

Osteoporosis is a systemic skeletal disease characterized by reduced bone mass and degradation of skeletal microstructures⁵. As life expectancy increases, the world demographics are likely to shift toward elderly populations, making senile osteoporosis a global challenge⁶. One of the most prevalent osteoporosis-related fractures is OVCF. Patients usually have clear symptoms of low back pain, with long-term conservative treatment and various complications, which seriously affect their quality of life⁶. PKP is a minimally - invasive technique that has achieved good results since its inception after a wide range of clinical applications⁷ and has become a routine means for the treatment of OVCFs. However, there is no comparative study on OVCFs with obvious traumatic factors and those without trauma.

Through the above retrospective study, the clinical symptoms and imaging findings of both groups fared much better than preoperative (p < 0.05). Compared with the trauma group, the variation value of Cobb angle, the rate of restoration of the damaged vertebra's anterior height, and the rate of restoration of the damaged vertebra's middle height were all lower than those of the trauma group (p < 0.05), and the bone cement leakage rate after PKP surgery in the non-trauma group was also lower than that in the trauma group (p < 0.05). There were several considerable differences in VAS scores and ODI indices between the two groups at preoperative, postoperative, and one year postoperative follow-up (p > 0.05), showing that PKP surgery has a good effect on relieving the pain and dysfunction caused by primary OVCF, consistent with previous studies^7,8. In the group comparison of OVCF with or without trauma factors, the efficacy of PKP surgery showed no statistical significance; that is, for OVCF with or without trauma, PKP surgery showed no significant impact on pain relief or functional recovery.

Bone cement leakage is one of the defects of percutaneous kyphoplasty, and after years of clinical research, PKP has been shown to effectively lower the possibility of bone cement leakage; however, this complication cannot be completely avoided⁹. Bone cement can leak into the epidural, foramina, disc, paraspinal soft tissue, paravertebral vein and puncture needle canal, and different types of leakage have different prognoses. Leakage of the intervertebral disc, paraspinal soft tissue and puncture channel usually does not result in clinical symptoms unless more bone cement leakage to the subcutaneous tissue can cause local pain symptoms. When the bone cement leaks into the intracanal epidural or intervertebral foramina, if the leakage is not too large to cause spinal canal or nerve root compression, there are no obvious clinical symptoms. If the spinal canal or nerve root is compressed, corresponding nerve compression symptoms can occur¹⁰. Symptomatic therapy cannot improve or even worsen the problem, and open surgery should be undertaken as soon as reasonably practicable compression to remove compression¹¹. Bone cement leakage into the perivertebral venous plexus and into the systemic circulation through the vertebral vein can cause organ embolism in severe cases, the most common of which is pulmonary embolism, endangering the patient's life. Moreover, leaky cement in the intervertebral space may be a potential factor in disc herniation or refracture of the adjacent vertebrae¹².

Compared to the preoperative period, both groups' symptoms improved dramatically in this research. In the group comparison, 25 of the 58 PKP patients in the trauma group had different degrees and sorts of bone cement leakage; in the nontraumatic group, only 5 of 27 PKP patients had bone cement leakage. Patients in both groups with bone cement leakage had no obvious clinical symptoms after the surgery, and the difference between the non-trauma group and trauma group was statistically significant. The non-trauma group's bone cement leakage rate was substantially lower than it is to the trauma group.. The reasons for this may be as follows: due to the obvious external force, the trauma group may have had invisible fractures or existing ruptures of the vertebral and lateral walls, which became severe in PKP after balloon expansion. Thus, the probability of cement leakage through fracture fissures or damaged external vertebral walls increased when the cement was injected, eventually resulting in a greater cement leakage rate than the non-trauma group. Related studies also have shown similar views¹³. At the same time, patients in the trauma group were affected by external force, and the damaged vertebral compression degree was larger than that in the non-trauma group, with a severe vertebral fracture degree, obvious vertebral collapse and clear vertebral height loss. During PKP, the recovery of vertebral body height was more apparent in the trauma group after balloon expansion. Therefore, compared with the non-trauma group, the correction effect of Cobb angle and kyphosis deformity was better.

The results of this study proved that, in PKP for OVCF with or without obvious trauma factors, there were almost no meaningful differences in the degree of pain alleviation or postoperative functional recovery. But, there were substantial disparities in the degree of correction of kyphosis deformity and the rate of bone cement leaking. This suggests that, for patients with OVCFs caused by trauma, special attention should be given to surgical skills during PKP surgery to reduce the possibility of bone cement leaks. Furthermore, the use of high-viscosity bone bone cement and focused distribution of bone cement during injection can help to prevent bone cement leakage¹⁴. Anti-osteoporosis treatment should be actively conducted after PKP, which can effectively prevent adjacent vertebral refracture¹⁵, to improve patient prognosis and quality of life in cooperation with surgery¹⁶.

Compared with patients with OVCF without trauma, patients with OVCF with trauma undergoing PKP surgery have a relatively high bone cement leakage rate, and the degree of Cobb angle recovery and the correction degree of vertebral kyphosis deformity are relatively good. This suggests that, for patients with OVCF who had a history of trauma, PKP skills should be considered, and the balloon should not be excessively expanded. Furthermore, cement should be pushed gently to decrease the rate of cement leakage., and the injection should be stopped immediately upon signs of cement leakage. For patients without trauma, balloon expansion should be returned to the original height of the damaged vertebra as much as feasible, and the kyphosis deformity should also be corrected. Moreover, anti-osteoporosis treatment should be actively performed to improve patient outcomes.

a. Ethics approval and consent to participate

To ensure confidentiality, the names of study participants were not included in the data. Information obtained from the data of the study participants is kept confidential. All studies were conducted in accordance with the Declaration of Helsinki. In addition, the Ethics Committee of The Affiliated Hospital of Soochow University approved the study. And informed consent was waived by the Ethics Committee of The Affiliated Hospital of Soochow University approved the study.

b. Consent for publication

Not applicable

c. Availability of data and materials

The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding authors.

d. Competing interests

The authors declare no conflict of interest.

e. Funding

This research received no external funding

f. Authors' contributions

Huazheng Wang initiated and conceived the project, collected patient information and processed and analyzed the data, created charts and wrote the article; Linlin Zhang verified the patient information, proposed the follow-up plan and guided the analysis of the data; Peng Liu and Chengnan Jing processed the charts based on the data and were responsible for the patient follow-up; Peng Yang and Shaofeng Yang provided several references and were responsible for the article touch-up; Dr. Minfeng Gan completed the final review and proofreading of the article and guided the article writing.

g. Acknowledgement

Not applicable.

He S, Zhang Y, Lv N, et al. The effect of bone cement distribution on clinical efficacy after percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Medicine (Baltimore). Dec 2019;98(50):e18217. doi:10.1097/MD.0000000000018217
Li Y, Yue J, Huang M, et al. Risk factors for postoperative residual back pain after percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Eur Spine J. Oct 2020;29(10):2568-2575. doi:10.1007/s00586-020-06493-6
Sun ZY, Li XF, Zhao H, et al. Percutaneous Balloon Kyphoplasty in Treatment of Painful Osteoporotic Occult Vertebral Fracture: A Retrospective Study of 89 Cases. Med Sci Monit. Apr 7 2017;23:1682-1690. doi:10.12659/msm.903997
Schnake KJ, Blattert TR, Hahn P, et al. Classification of Osteoporotic Thoracolumbar Spine Fractures: Recommendations of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU). Global Spine J. Sep 2018;8(2 Suppl):46S-49S. doi:10.1177/2192568217717972
Wang S, Feng W, Liu J, et al. Alginate oligosaccharide alleviates senile osteoporosis via the RANKL-RANK pathway in D-galactose-induced C57BL/6J mice. Chem Biol Drug Des. Jan 2022;99(1):46-55. doi:10.1111/cbdd.13904
Garg B, Dixit V, Batra S, Malhotra R, Sharan A. Non-surgical management of acute osteoporotic vertebral compression fracture: A review. J Clin Orthop Trauma. Apr-Jun 2017;8(2):131-138. doi:10.1016/j.jcot.2017.02.001
Clark W, Bird P, Gonski P, et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trial. The Lancet. 2016;388(10052):1408-1416. doi:10.1016/s0140-6736(16)31341-1
Yang H, Chen L, Zheng Z, et al. Therapeutic effects analysis of percutaneous kyphoplasty for osteoporotic vertebral compression fractures: A multicentre study. J Orthop Translat. Oct 2017;11:73-77. doi:10.1016/j.jot.2017.04.003
Wang F, Wang LF, Miao DC, Dong Z, Shen Y. Which one is more effective for the treatment of very severe osteoporotic vertebral compression fractures: PVP or PKP? J Pain Res. 2018;11:2625-2631. doi:10.2147/JPR.S179022
Zhang S, Wang GJ, Wang Q, Yang J, Xu S, Yang CH. A mysterious risk factor for bone cement leakage into the spinal canal through the Batson vein during percutaneous kyphoplasty: a case control study. BMC Musculoskelet Disord. Sep 12 2019;20(1):423. doi:10.1186/s12891-019-2807-6
Li Z, Yu K, Chang X, Cai S, Gao J, Wang Y. Cement leakage following percutaneous kyphoplasty in a patient after a posterior lumbar fusion: a case report. BMC Surg. Apr 15 2020;20(1):74. doi:10.1186/s12893-020-00733-8
Gao C, Zong M, Wang WT, Xu L, Cao D, Zou YF. Analysis of risk factors causing short-term cement leakages and long-term complications after percutaneous kyphoplasty for osteoporotic vertebral compression fractures. Acta Radiol. May 2018;59(5):577-585. doi:10.1177/0284185117725368
Li Z, Liu T, Yin P, et al. The therapeutic effects of percutaneous kyphoplasty on osteoporotic vertebral compression fractures with or without intravertebral cleft. Int Orthop. Feb 2019;43(2):359-365. doi:10.1007/s00264-018-4007-7
Lu Q, Gao S, Zhou M. The effect of bone cement on the curative effect of percutaneous kyphoplasty in the treatment of osteoporotic vertebral compression fracture. Ann Palliat Med. Oct 2021;10(10):11013-11023. doi:10.21037/apm-21-2767
Ma X, Xia H, Wang J, et al. Re-fracture and correlated risk factors in patients with osteoporotic vertebral fractures. J Bone Miner Metab. Jul 2019;37(4):722-728. doi:10.1007/s00774-018-0974-4
Huang S, Zhu X, Xiao D, et al. Therapeutic effect of percutaneous kyphoplasty combined with anti-osteoporosis drug on postmenopausal women with osteoporotic vertebral compression fracture and analysis of postoperative bone cement leakage risk factors: a retrospective cohort study. J Orthop Surg Res. Dec 18 2019;14(1):452. doi:10.1186/s13018-019-1499-9

No competing interests reported.

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Percutaneous Kyphoplasty for Osteoporotic Vertebral Compression Fractures With or Without Trauma

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