Is percutaneous vertebroplasty safe and effective in treating sacral compression fractures in patients with osteoporosis?

doi:10.21203/rs.3.rs-4708599/v1

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Is percutaneous vertebroplasty safe and effective in treating sacral compression fractures in patients with osteoporosis?

https://doi.org/10.21203/rs.3.rs-4708599/v1

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Background: Percutaneous vertebroplasty (PVP) is widely used to treat osteoporotic thoracic and lumbar vertebral compression fractures. Currently, no study has indicated the clinical efficacy and safety of percutaneous vertebroplasty in the treatment of osteoporotic sacral compression fractures.

Measures: Pain symptoms and daily function were evaluated 1 day before surgery, 1 \ 7 \14 \0 days after surgery and 6 months after surgery, using the numerical rating scale (NRS) and Oswestry disability index (ODI). The presence of bone cement leakage was evaluated by reading postoperative imaging data.

Results: The study population comprised 72 patients (17 men and 55 women; 64–87 years).

All patients were followed-up for 1 day to 6 months. No postoperative complications, lumbago and back pain were significantly relieved in the patients, and the NRS and ODI scores were significantly improved compared with the preoperative values. At the last follow-up, none of the patients had evident sacral tail pain and were able to take care of themselves in daily life.

Conclusions:Early vertebroplasty can reduce pain symptoms, accelerate return to self-care, and limit related symptoms in patients with osteoporotic sacral compression fractures without surgical contraindications in accordance with modern enhanced recovery after surgery (ERAS).

Biological sciences/Biological techniques

Biological sciences/Biotechnology

Percutaneous vertebroplasty

Sacral vertebral fractures

Osteoporosis

Curative effect

Safety

Since Galibert¹ first reported successful percutaneous vertebroplasty (PVP) for the treatment of vertebral hemangiomas in 1987, this technique has been expanded to the treatment of osteoporotic spinal compression fractures and vertebral tumors with satisfactory results^2–5. With the continuous advances in technology, the surgical adaptation of PVP has expanded; it is widely used to treat segmental symptomatic osteoporotic compression fractures (OVCF) at various vertebral levels and exerts analgesic effect and minimal invasion⁶. In clinical practice, compression fractures of the osteoporotic vertebrae are most common in the thoracolumbar vertebrae, whereas compression fractures of the sacral vertebrae occur occasionally. Osteoporotic sacral vertebral compression fractures also worsen when sitting up and moving, which can easily cause intractable sacrococcygeal pain and seriously affect patients’ quality of life in the absence of timely interventional treatment^7–9. Previously, conservative treatment was often recommended for osteoporotic sacral compression fractures, with patients experiencing partial relief of lumbosacral pain after treatment, but being prone to lingering lumbosacral pain, which seriously affects quality of life. In addition, osteoporotic sacral compression fractures occur generally in older adults with underlying diseases and poor general condition. Because conservative treatment requires long-term oral drug therapy, which has a high risk of related complications, it is not the best approach for osteoporotic sacral compression fractures. With an aging global society, the number of patients with osteoporosis is increasing. Conservative treatment is gradually becoming unacceptable for osteoporotic sacral compression fractures, and an increasing number of patients with this type of fractures require surgical intervention. There are numerous reports on vertebroplasty for the treatment of osteoporotic thoracolumbar vertebral compression fractures; however, few studies have examined its clinical therapeutic efficacy and safety. Therefore, we posed the following question: Is surgical intervention necessary for sacral compression fractures, and what is its efficacy and safety? In view of this, this study analyzed the clinical efficacy and safety of PVP in 72 patients with osteoporotic sacral compression fractures who were hospitalized in our hospital from January 2013 to December 2023.

2.1 Inclusion and exclusion criteria

Admission criteria: (1) a history of senile osteoporosis; (2) radiography- and magnetic resonance imaging (MRI)-confirmed new OVCF; (3) sacrococcygeal pain, with a visual analog scale score above 4; (4) receiving PVP treatment; and (5) having imaging and questionnaire score data from postoperative follow-up (> 6 months). Exclusion criteria: (1) pathological fracture, (2) history of sacrococcygeal surgery, and (3) new vertebral compression fractures in other segments.

2.2 General information

Based on the above inclusion and exclusion criteria, 72 patients with osteoporotic sacral compression fractures who visited our hospital between January 2013 and December 2023 were included. The patients included 17 men and 55 women aged 64–87 (average, 81.17 ± 8.75) years. All patients stayed in bed for 5–12 (7.17 ± 2.17) days at admission. The T values of the sacral vertebra density of the patients ranged from − 5.6 to -3.8 (-4.82 ± 0.69) T. All 72patients had a history of hip-first fall injury. This study was approved by the hospital ethics committee[2012–016 − 9], and informed consent was obtained from all patients.

2.3 Surgical method

Surgery was performed under intravenous general anesthesia and auxiliary local anesthesia. After successful electrocardiographic monitoring, each patient was placed prone on the operating bed, disinfected, and draped using a C-arm X-ray machine to locate the lesion in the S1 vertebral body. Local anesthesia using 0.5% lidocaine was applied to the local skin, muscle tissue, and upper articular processes on both sides of the sacral vertebra (S1). After successful administration of local anesthesia, intravenous general anesthesia was administered. A 2–3 mm small incision was made on the S1 vertebral body using a pointed blade, and a PVP system puncture needle was inserted along the bilateral pedicle towards the vertebral body along the incision. The position of the puncture needle was adjusted using a C-arm X-ray machine. The projection position of the left pedicle was adjusted to 9 o'clock and that of the right pedicle to 3 o'clock. Needle puncture did not exceed the sacral midline. After the depth of the puncture needle was confirmed to be accurate based on the C-arm X-ray machine, the needle core was pulled out, and a bone cement gun was used to push the bone cement with appropriate viscosity into the vertebral body. Bone cement was injected into the vertebral body using a bone cement gun. The bone cement injection process must be completed under fluoroscopy to ensure good bone cement distribution. After the bone cement solidified, the puncture needle was pulled out, and the wound was covered with sterile dressing. The surgical process was smooth, intraoperative anesthesia was satisfactory, vital signs were stable, and there was no bleeding. The patients were instructed to move their lower limbs without abnormalities, and reductions in postoperative pain and functional recovery were recorded.

2.4 Postoperative management and related evaluation indexes

Each patient’s vital signs were closely observed after surgery, surgical efficacy at 1 day before surgery, 1 day after surgery, 7 days after surgery, 14 days after surgery, 30 days after surgery, and 6 months after surgery were follow-up using the numerical rating scale (NRS) and the Oswestry disability index (ODI). Postoperative routine re-examination of sacral vertebral anteroposterior and lateral radiographs was performed to evaluate bone cement dispersion, with two senior spine physicians and one senior radiologist jointly reviewing the films to determine the presence of bone cement leakage. If the three doctors had different opinions, a computed tomography scan was performed for clarification.

2.5 Statistical method

Statistical analysis of the data was conducted using SPSS software (version 26.0). Single-factor repeated-measures analysis of variance was used to analyze changes in indicators at different time points, and pairwise comparisons were performed using Bonferroni correction, represented by mean ± standard deviation. Linear regression was used to analyze the influencing factors of the preoperative NRS, postoperative day 1 NRS, preoperative ODI, and postoperative day 1 ODI. Bilateral testing showed statistical significance, with a difference of p < 0.05.

3.1 Assessment of the impact of general patient information on preoperative and postoperative ODI and NRS scores

Factors influencing the preoperative NRS score were determined using general patient information. Linear regression analysis was used to evaluate the influence of the factors on the preoperative NRS score, and factors with a P value of < 0.1 were included in the multivariate logistic regression model. The results of multiple linear regression analysis showed that the regression model was statistically significant (F = 20.987, P < 0.001), with an adjusted R² of 0.631. The results showed that among the three indicators, the preoperative ODI was statistically significant (P < 0.001), indicating that the preoperative NRS score significantly influenced the preoperative ODI score (Table 1).

Analysis of factors influencing the preoperative NRS score based on general patient information (Table 1).

Index	Single factor analysis					Multifactor analysis
Index	t-v			P-v	CoefficientB(95%CI)	t-v	P-v	CoefficientB(95%CI)
Gender	-1.902			0.066	-0.813(-1.681 ~ 0.056)	-0.124	0.902	-0.043(-0.748 ~ 0.663)
Age	-0.532			0.598	-0.015(-0.072 ~ 0.042)
BMI	-0.139			0.891	-0.015(-0.239 ~ 0.209)
Smoke	-1.934		0.061		-1.182(-2.424 ~ 0.060)	-0.895	0.378	-0.438(-1.436 ~ 0.559)
Drink	-0.711			0.482	-0.455(-1.753 ~ 0.844)
BMD	-1.013			0.318	-0.323(-0.972 ~ 0.326)
DIAB	0.090			0.929	0.037(-0.798 ~ 0.872)
HTN	0.503			0.619	0.214(-0.652 ~ 1.081)
CHD	1.684			0.101	0.832(-0.172 ~ 1.837)
Pre-op ODI		7.909		< 0.001	0.089(0.066 ~ 0.111)	7.174	< 0.001	0.085(0.061 ~ 0.109)
(Notes: t-v, t value; P-v, P value, the following are the same.)

Factors influencing postoperative day 1 NRS scores were determined using general patient information. Linear regression was used to evaluate the influencing factors of the NRS score on postoperative day 1. Single-factor indicators with a P value of < 0.1 were included in the multivariate logistic regression model. The results of the multiple linear regression analysis showed that the regression model was statistically significant (F = 5.812, P = 0.021), with an adjusted R² = 0.121. The preoperative NRS score was statistically significant (P = 0.021), indicating that it significantly influenced the postoperative day 1 NRS score (Table 2).

Analysis of factors influencing postoperative day 1 NRS scores was based on general patient information (Table 2).

Index	Single factor analysis			Multifactor analysis
Index	t-v	P-v	CoefficientB (95%CI)	t-v	P-v	CoefficientB(95%CI)
Gender	0.586	0.562	0.291(-0.717 ~ 1.299)
Age	-0.457	0.650	-0.014(-0.077 ~ 0.049)
BMI	-0.462	0.647	-0.056(-0.304 ~ 0.191)
Smoke	-0.814	0.421	-0.576(-2.012 ~ 0.861)
Drink	0.212	0.833	0.152(-1.298 ~ 1.601)
BMD	0.406	0.687	0.146(-0.583 ~ 0.874)
DIAB	-0.244	0.809	-0.111(-1.036 ~ 0.814)
HTN	-0.188	0.852	-0.089(-1.053 ~ 0.875)
CHD	-0.811	0.423	-0.458(-1.606 ~ 0.690)
Pre-op NRS	2.411	0.021	0.424(0.067 ~ 0.781)	2.411	0.021		0.424(0.067 ~ 0.781)
Pre-op ODI	0.945	0.351	0.020(-0.022 ~ 0.062)
Post-po 1d ODI	0.765	0.450	0.021(-0.035 ~ 0.078)

3.2 Analysis of factors influencing preoperative ODI based on general patient information

Linear regression was used to evaluate the factors influencing preoperative ODI. Single-factor indicators with P < 0.1 were entered in the multivariate logistic regression model. The results of the multiple linear regression analysis showed that the regression model in this study was statistically significant (F = 30.574, P < 0.001), with an adjusted R² of 0.628. The results showed that between the two included indicators, the preoperative NRS was statistically significant (P < 0.001), indicating that this indicator significantly influenced the preoperative ODI score (Table 3).

Analysis of factors influencing preoperative ODI score based on general patient information (Table 3).

Index	Single factor analysis			Multifactor analysis
Index	t-v	P-v	CoefficientB (95%CI)	t-v	P-v	CoefficientB (95%CI)
Gender	-1.752	0.089	-6.847(-14.791 ~ 1.097)	-0.389	0.700	-1.004(-6.253 ~ 4.245)
Age	-1.282	0.209	-0.319(-0.826 ~ 0.187)
BMI	0.430	0.670	0.429(-1.599 ~ 2.457)
Smoke	-1.465	0.152	-8.303(-19.823 ~ 3.217)
Drink	-0.552	0.585	-3.212(-15.037 ~ 8.613)
BMD	-0.592	0.558	-1.732(-7.682 ~ 4.217)
DIAB	-1.154	0.257	-4.222(-11.659 ~ 3.215)
HTN	0.101	0.920	0.393(-7.502 ~ 8.288)
CHD	0.614	0.543	2.852(-6.589 ~ 12.292)
Pre-op NRS	7.909	< 0.001	7.308(5.430 ~ 9.185)	7.304	< 0.001	7.189(5.186 ~ 9.191)

3.3 Analysis of factors influencing postoperative day 1 ODI score based on general patient information

This study used linear regression to evaluate the factors influencing postoperative day 1 ODI. Single-factor indicators with a P value of < 0.1 were included in the multivariate logistic regression model. The results of the multiple linear regression analysis showed that the regression model was statistically significant (F = 64.139, P < 0.001), with an adjusted R² of 0.783. The results showed that among the two included indicators, preoperative ODI was statistically significant (P < 0.001), indicating that this factor significantly influenced the postoperative day 1 ODI score (Table 4).

The analysis of factors influencing postoperative day 1 ODI score was based on general patient information (Table 4)

3.4 Comparison of preoperative and postoperative lower back pain and dysfunction

All patients were followed up for 1–6 months after surgery. The surgical time was 32–56 of (45.33 ± 8.09) minutes. The patient’s vital signs were stable under electrocardiographic monitoring during surgery. On the first day after surgery, the patients’ lumbosacral pain was significantly relieved, and their mental state, appetite, sleep, and lower back function improved compared to their preoperative states. NRS and ODI scores also improved compared to the preoperative values. During the 14-day, 1-month, 3-month, and 6-month follow-ups, the patient’s NRS and ODI scores significantly improved. At the 6-month follow-up, physical examination showed no significant pain on sacrococcygeal percussion in any patient (Table 5).

Comparison of preoperative and postoperative lower back pain and dysfunction (n = 72) (Table 5)

Index

Pre-op

Post-op

1 days

Post-op

7 days

Post-op

14 days

Post-op

30 days

Post-op

3months

Post-op

6 months

NRS

7.08 ± 1.05

6.19 ± 1.17*

3.97 ± 0.77*#

3.03 ± 0.94*#

1.47 ± 0.88*#

1.00 ± 0.79*

0.78 ± 0.64*

ODI

76.94 ± 9.55

75.58 ± 7.14*

52.14 ± 7.80*#

24.94 ± 6.16*#

4.08 ± 3.19*#

2.72 ± 2.53*

1.64 ± 1.69*

(Note: * represents P < 0.05 compared to preoperative, # represents P < 0.05 compared to the previous follow-up.)

The results showed that there was a statistically significant difference in the distribution of NRS scores at different time points for the NRS scoring indicators (F = 325.164, p < 0.001). In pairwise comparisons, preoperative scores were significantly higher than postoperative scores at 1, 7, 14, 30 days, and 3 and 6 months (P < 0.05). The scores on the first day after surgery were significantly higher than those on the 7th, 14th, and 30th postoperative days, as well as at 3 and 6 months after surgery (P < 0.05). The postoperative rates were significantly higher at 7 days than at 14 and 30 days and at 3 and 6 months after surgery (P < 0.05). The rates at 14 days after surgery were significantly higher than those at 30 days and at 3 and 6 months after surgery (P < 0.05), and those at 30 days after surgery were significantly higher than those at 6 months after surgery (P < 0.05). There were no statistically significant differences (P > 0.05) between 3 months, 30 days, and 6 months postoperatively (Table 5). In the ODI scoring indicators, there was a statistically significant difference in the distribution of ODI at different time points (F = 1336.566), p < 0.001). In pairwise comparisons, preoperative levels were significantly higher than postoperative levels at 1, 7, 14, and 30 days, and 3 and 6 months (P < 0.05). The level on the first day after surgery was significantly higher than that on the 7th, 14th, and 30th days after surgery, as well as at 3 and 6 months after surgery (P < 0.05). The postoperative rates were significantly higher at 7 days than at 14 and 30 days, and at 3 and 6 months after surgery (P < 0.05). The rates at 14 days after surgery were significantly higher than those at 30 days and at 3 and 6 months after surgery (P < 0.05). Moreover, the rates 30 days after surgery were significantly higher than those 6 months after surgery (P < 0.05). There was no statistically significant difference (P > 0.05) between preoperative and postoperative 1 day, and there was no statistically significant difference (P > 0.05) between postoperative 3 months, 30 days, and 6 (Table 5).

3.5 Preoperative and postoperative imaging statuses of the 72 patients

Among the 72 patients in this study, four were ambulatory 6 hours after surgery, while the remaining patients became ambulatory on the second day after surgery. On the postoperative 7th day, the pain in the lumbosacral region was significantly relieved when the patients were placed in a sitting position. On the 30th day after surgery, there was no significant pain in the lumbosacral region when the patients were placed in a sitting position. At the postoperative 6th month, there was no pain in the sacrococcygeal region during percussion. The 72 patients were hospitalized for 5–12 (7.17 ± 2.17) days. After discharge, the patient underwent regular outpatient follow-up and continued to receive oral calcium supplements to treat osteoporosis

3.7 Complications among the follow-up subset after discharge

Three of the follow-up patients developed a compression fracture of the adjacent vertebra (L5) on the 2-4th month after surgery without any obvious cause, in addition to significant lower back pain and limited mobility. The pain was relieved after L5 PKP. The 72 patients were followed up for 6 months after surgery and underwent the last follow-up physical examination. There was no significant percussion pain in the sacrococcygeal region of the patients, and they could take care of themselves in their daily lives.

4.1 Operative indication and timing of PVP surgery for osteoporotic sacral compression fracture

Osteoporotic vertebral compression fracture is a common cause of ADL independence loss in older adults. There are no relevant literature reports on compression fractures of the osteoporotic sacrum, and it can be considered that its surgical indications are similar to those of thoracic and lumbar compression fractures. Previous literature suggests that older patients with OVCF should undergo 2–4 weeks of conservative treatment before considering vertebral body reconstruction surgery¹⁰ .In 2010, Röllinghoff et al¹¹ conducted a survey of 160 physicians and found the following consensus on surgical indications for older patients with OVCF: ① pain and limited mobility at the fracture site remaining after 2–3 weeks of conservative treatment; ② pathological compression fractures of tumors causing pain; ③ invasive hemangioma; and ④ Son S et al¹² compared the surgical periods in two groups of patients with OVCF and found no significant difference in long-term efficacy between the group of patients who underwent surgery immediately after OVCF diagnosis and the conservative treatment group after 2 weeks of ineffective reoperation. However, early surgery can rapidly relieve pain, shorten hospitalization time, and avoid complications related to conservative treatment (such as gastrointestinal stress reactions caused by oral analgesics). The benefits of early surgery are significantly lower than those of late surgery, and patients still recover quickly, which is in line with the concept and requirements of modern ERAS.

4.2 Treatment effect of osteoporotic sacral compression fracture

The patients in this study had a history of trauma before falling and landing on their buttocks. Significant lumbosacral pain and limited mobility were observed after the injury. The preoperative NRS score was (8.50 ± 1.05), and the NRS score was (4.83 ± 0.75) on the first day after surgery. After surgical treatment, lumbosacral pain was significantly relieved (P < 0.01, Table 5). All patients showed improvements in mental state, appetite, and sleep on the first postoperative day (Tables 1–5). The preoperative ODI score was (80.50 ± 3.62), and the ODI decreased to (42.17 ± 3.66) on the first day after surgery. Some patients leave the bed and move around 6 hours after surgery. On the 7th day after surgery, pain in the lumbosacral region was significantly relieved compared to before surgery, when the patients were placed in a sitting position. Early surgical intervention for osteoporotic sacral fractures can achieve significant results, avoiding the occurrence of related complications caused by previous conservative treatments and accelerating subsequent rehabilitation, such as ambulation after injury, which is more in line with the current ERAS concept¹³. Therefore, we believe that PVP should be performed as early as possible in patients with OVCF, provided that the patient’s overall condition does not contraindicate surgery. This can avoid the complications of conservative treatment, help patients improve their symptoms, restore self-care as soon as possible, improve their quality of life in later stages, and reduce medical costs and expenses¹⁴.

4.3 Safety of percutaneous vertebroplasty for the treatment of osteoporotic sacral compression fractures

4.3.1 Anatomical characteristics and puncture safety of sacral vertebra

The ninth edition of the textbook on systematic anatomy defines the pedicle as the narrow part of the vertebral arch that is tightly connected to the vertebral body.¹⁵ The upper and lower edges of the pedicle, together with the upper and lower incisions of the adjacent vertebrae, form the intervertebral foramen, which is traversed by the spinal nerves and blood vessels. All patients in this study had a history of injury arising from when they fell and landed on their buttocks. After the injury, the sacrococcygeal region experienced significant pain during walking and sitting. MRI and radiography revealed that the fracture was located in the S1 and S2 vertebral bodies. Owing to the fusion of the five sacral vertebrae, sacral vertebrae do not have a true pedicle, according to the anatomical definition. We refer to the fusion of the S1 and S2 vertebral bodies and the posterior lamina as the pedicle, which is distributed in a fan-shaped pattern from the posterior and lateral sides to the anterior and medial sides. The range from the inner edge of the sacral posterior foramen to the anterior edge of the auricular plane is the radiation range of the S1 and S2 pedicles, which means that the S1 and S2 pedicles are relatively broad compared to the pedicles of the thoracic and lumbar vertebrae. Part of the dural sac is located within the sacral canal. The lower end of the dural sac is generally located at the level of the second sacral vertebra. The sacral canal is adjacent to the inner edge of the intervertebral foramen. The sacral nerves and accompanying blood vessels run outwards and downwards on both sides of the sacral canal. The sympathetic nerves in front of the sacrum are close to the inner edge of the sacral foramen, and the sacral median artery and vein descend near the midline of the sacrum. No large nerves or blood vessels pass between the sacral sympathetic nerves and the sacral median artery. This area can be considered safe in front of the sacrum. Therefore, there was sufficient space to place a combination probe sleeve for the vertebral body shaping system through the S1 and S2 pedicle screws¹⁶. Because of the sufficient width of the S1 and S2 pedicles and the presence of a safety zone in front of the sacrum, the puncture insertion point behind the sacrum can be determined¹⁷. During surgery, the patient was positioned using a C-arm X-ray machine. The sacral anteroposterior film is bounded by the midline of the sacrum, and the puncture needles on the left and right sides do not exceed the midline of the sacrum. The puncture needles on the sacral lateral film do not exceed the inner edge of the sacral foramen, which is the intersection point between the anterior edge of the S1 and S2 pedicles and the vertebral body. Following the aforementioned anatomical points and positioning techniques, the combined probe cannula was accurately and safely inserted in all patients in this study.

4.3.2 PVP-related surgical techniques for osteoporotic sacral compression fractures

PVP technology is an orthopedic intervention procedure guided by imaging techniques, including C-arm X-ray, CT, or a combination of the two as auxiliary methods¹⁸. Presently, scholars such as BAST and MATHIS^19–20 believe that operating under X-ray dynamic fluoroscopy has the advantage of real-time detection of puncture needle placement, bone–cement dispersion, and the occurrence of bone–cement cone extravasation. However, fluoroscopy is not satisfactory for lesion observation, and the position of the needle tip in the vertebral body and its relationship with the lesion remain unclear. Fluoroscopy only monitors leakage at the posterior edge of the vertebral body, and the bone–cement shadow in the vertebral body overlaps with the lateral leakage bone–cement shadow. Even a biplane X-ray fluoroscopy system (G-arm) cannot fully ensure the early detection of lateral leakage of bone cement in the vertebral body. Although CT guidance has the advantages of precise positioning and a clear display of anatomical structures, operations under CT monitoring cannot be dynamically observed, and bone cement filling outside the scanning plane is often overlooked and time-consuming²¹. The two aforementioned guidance techniques have advantages and disadvantages. Currently, the safest method for PVP is to operate under the guidance of C-arm X-ray fluoroscopy combined with CT, which ensures the accuracy of positioning and allows the observation of the flow and injection amount of bone cement in real time. However, the equipment requirements are high, and many hospitals cannot meet these requirements, which is not conducive to the development of the clinical practice of this approach²². Therefore, in this study, preoperative MRI combined with XR was used to confirm sacral vertebral compression fractures. During surgery, a C-arm X-ray machine was used to determine the distance of the spinous process opening on the skin and the angle and depth of needle insertion through the pedicle. Based on this finding, the puncture operations were performed under fluoroscopy. The results showed that this method is simple, accurate, and has strong operability, greatly reducing the operative time. All 72 bilateral punctures were successfully performed. Scholars such as Jiang Xiaobing believe that the dispersion of bone cement in PVP is related to the degree of vertebral osteoporosis and the location of the puncture tube. Preoperative imaging accurately determined the position of the fracture line. During surgery, bone cement is injected along the fracture line through bilateral pedicle punctures and catheters, making it easier for the cement to penetrate and evenly disperse within and around the fracture line. Poor cement dispersion within the vertebral fracture line may occur if the puncture pipeline deviates significantly from the fracture line during surgery^23–24. This study found that patients with high T-values, large trabeculae, and small gaps in bone trabeculae had poor penetration and dispersion of bone cement in the vertebral body after surgery, based on the measurement of T-values of bone density and observation of bone trabeculae in XR slices. In contrast, if the T-value of the patient's bone density measurement is low, the vertebral body would be severely osteoporotic, the radiography film would show sparse bone trabeculae and large gaps, and bone cement penetration and diffusion in the vertebral body would be better. In this study, the bone density of the patients with poorly dispersed bone cement was significantly higher than that of those with good dispersion.

4.3.3 Safety of bone cement injection

One of the most common complications of vertebroplasty is the leakage of bone cement, the most serious of which can endanger patients. Nakshabandi²⁵ classified PVP complications of percutaneous vertebroplasty into three types based on the severity of symptoms: mild, moderate, and severe. Bone cement leakage into intervertebral discs or paravertebral soft tissues is a mild complication, and leakage into the epidural space and intervertebral foramen is a moderate complication. Severe complications, such as pulmonary embolism, renal embolism, cardiac perforation, cerebral embolism, and even death, are caused by bone cement leakage into the paravertebral vein. Papadopoulos et al²⁶ reported that the incidence of bone cement leakage in unilateral PKP was 10.73%. Liang et al²⁷ found that the total leakage rate of single and bilateral PKP surgery was 14.63%. In this study, there was no bone cement leakage, which may be related to our strict control of surgical indications, improvement in bone cement viscosity, appropriate injection dosage, and precise intraoperative positioning. Kaufmann et al²⁸ confirmed through relevant clinical studies that there is no direct relationship between the amount of bone cement injected and the clinical pain relief effect. However, the more bone cement is injected, the more likely complications are to occur. The amount of bone cement injected through bilateral punctures during surgery will significantly increase compared to unilateral injection. However, no significant differences were observed in the overall clinical effect. Moreover, bilateral surgery was associated with a slightly higher bone cement leakage rate than unilateral injection²⁹ .Therefore, it is important to correctly determine the injection method, timing, and dosage of bone cement³⁰ .Currently, polymethyl methacrylate is a commonly used type of bone cement in clinical practice, with a setting time of approximately 5–10 minutes, which is greatly affected by factors such as the dilution ratio of the cement, environmental temperature, and production batch. In the past, to prevent leakage due to excessive pushing when injecting bone cement into the thoracic and lumbar vertebrae with a PVP puncture cannula, we often injected 0.3–0.5 mL first, and then continued to inject the cement slowly after observing radiography with C-arm machine findings and finding no obvious leakage trend. This method has been proven to be safe and effective. Previous studies have reported injection treatment of osteoporotic fractures in the upper thoracic vertebrae in which filling multiple 1 mL syringes with rarefied bone cement are used. Other researchers have reported the injection of a certain amount of adhesive before bone cement injection, both aimed at effectively controlling the amount of bone cement injection and preventing leakage, achieving good results.³¹ All patients in this study were treated with a PVP system puncture cannula and bone cement injection push rod to maintain a certain bone cement pressure, and the cement was slowly pushed into the vertebral body along the cannula with no leakage. In a safety study of bone cement injection volume, Guanming et al³² found that injecting less than 3 mL of bone cement into the thoracic vertebrae and less than 5 mL of bone cement into the lumbar vertebrae was safe, with no serious complications, such as bone cement leakage. Satisfactory results were achieved through PVP and PKP treatment in over 150 cases with over 400 vertebral bodies. In this study, the 72 cases and 72 segments of the sacral vertebrae were the S1 vertebrae. Due to the special anatomy of the sacral vertebrae, the average amount of bone cement injection was (3.33 ± 0.54) mL/vertebral body, and no leakage occurred. Postoperative pain in the sacrococcygeal region was effectively relieved in all patients. Therefore, injecting a certain amount of bone cement is safe and satisfactory for the treatment of osteoporotic sacral compression fractures.

4.3.4 Shortcomings of the study

Only 72 patients were included. Owing to significant pain in the lumbosacral region, all patients underwent surgical treatment, and there was no comparison of the advantages and disadvantages of vertebral body reconstruction surgery and conservative treatment. Determining the safety limits and effects of bone cement injection can only be performed in case series studies without a control group, and whether PVP surgical treatment is superior to conservative treatment in osteoporotic sacral compression fractures remains unclear.

In summary, patients with osteoporotic sacral vertebral compression fractures should undergo percutaneous vertebroplasty surgery as early as possible without obvious surgical contraindications. Early surgical intervention and treatment can reduce pain symptoms and accelerate recovery to allow self-care, which is consistent with modern ERAS principles.

PVP Percutaneous vertebroplasty

PKP Percutaneous kyphoplasty

OVCF Osteoporotic vertebral compression fracture

NRS Numerical rating scale

ODI Oswestry disability index

MRI Magnetic resonance imaging

CT Computed tomography

ERAS Enhanced recovery after surgery

ADL Activities of daily Living

ACKNOWLEDGMENTS

We thank the patient and investigators involved in this study.

AUTHOR’S CONTRIBUTIONS

Hao xi Li and Guang bing Qin designed the study; Guang bing Qin and Zhao jie Qin searched relevant studies \ analyzed and interpreted the data; Zhuo Nong capture and measure picture data; Guang Bing Qin and Zhao jie Qin wrote the manuscript and Hao xi Li approved the final version of the manuscript.

FUNDING

Not applicable.

AVAILABILITY OF DATA AND MATERIALS

All relevant data are provided in the manuscript are available from the corresponding author upon reasonable request.

Ethics approval and consent to participate

The Regional Ethics Committee of Liu Tie Center Hospital approved the study protocol (Approval ID No 2012–016-9). The patients/participants provided their written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article. All methods were performed in accordance with the relevant guidelines of Declaration of Helsinki and the relevant guidelines provided by the Ethics Committee of The Regional Ethics Committee of Liu Tie Center Hospital, and all participants provided signed written informed consents in accordance with the Declaration of Helsinki.

CONSENT FOR PUBLICATION

Not applicable.

COMPETING INTERESTS

The authors declare no competing interests.

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No competing interests reported.

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Is percutaneous vertebroplasty safe and effective in treating sacral compression fractures in patients with osteoporosis?

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Abstract

Figures

1. INTRODUCTION

2. METHODS

2.1 Inclusion and exclusion criteria

2.2 General information

2.3 Surgical method

2.4 Postoperative management and related evaluation indexes

2.5 Statistical method

3. RESULTS

3.2 Analysis of factors influencing preoperative ODI based on general patient information

3.3 Analysis of factors influencing postoperative day 1 ODI score based on general patient information

3.4 Comparison of preoperative and postoperative lower back pain and dysfunction

3.5 Preoperative and postoperative imaging statuses of the 72 patients

3.7 Complications among the follow-up subset after discharge

4. DISCUSSION

4.1 Operative indication and timing of PVP surgery for osteoporotic sacral compression fracture

4.2 Treatment effect of osteoporotic sacral compression fracture

4.3 Safety of percutaneous vertebroplasty for the treatment of osteoporotic sacral compression fractures

4.3.1 Anatomical characteristics and puncture safety of sacral vertebra

4.3.2 PVP-related surgical techniques for osteoporotic sacral compression fractures

4.3.3 Safety of bone cement injection

4.3.4 Shortcomings of the study

Abbreviations

Declarations

References

Additional Declarations

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