Percutaneous vertebroplasty brace for thoracolumbar osteoporosis CIA

2021-11-12 12:11:51 By : Mr. Mao Joseph

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Back to Journal »Clinical Interventions for Aging» Volume 14

Percutaneous vertebroplasty is not effective in the treatment of thoracolumbar osteoporotic vertebral compression fractures

Authors: Zhang Jie, Fan Yi, He Xue, Du Jie, Hao De

Published on February 5, 2019, Volume 2019: 14 pages, pages 265-270

DOI https://doi.org/10.2147/CIA.S192821

Single anonymous peer review

Editor approved for publication: Dr. Wu Zhiying

Jiannan Zhang, Yong Fan, Xin He, Jinpeng Du, Dingjun Hao, Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an 710054, Shaanxi Province, China Purpose: The purpose of this study was to evaluate the percutaneous vertebroplasty (PVP) posterior brace Effectiveness of treatment of thoracolumbar osteoporotic vertebral compression fractures (OVCF). Methods: This is a retrospective study. We recruited 138 patients with single-segment thoracolumbar OVCF who received PVP from January 2018 to March 2018 (Group A). The visual analog scale (VAS) and vertebral compression ratio (VCR) were recorded before surgery, on the second day after surgery, 2 weeks, 1 month, and 6 months after surgery. The Oswestry Disability Index (ODI) was recorded before surgery, 2 weeks, 1 month, and 6 months after surgery. Propensity score matching identified 138 historical patients (group B) as the control group. They used six independent variables (preoperative) from January 2017 to December 2017: age, gender, VAS, ODI, bone mineral density , Use a rigid brace, and body mass index within 3 weeks after surgery. The indicators and complications of the two groups were compared. Results: Compared with preoperatively, the VAS and VCR of the two groups were significantly improved on the second postoperative day (P<0.05). At 2 weeks, 1 month, and 6 months after PVP, ODI, VAS, and VCR were significantly improved compared with those before operation (P<0.05). There was no statistically significant difference in VAS and VCR between the two groups on the second day, the first month, and the sixth month after PVP (P>0.05). There was no significant difference in ODI between groups A and B at 2 weeks and 6 months after surgery (P>0.05), but ODI at 1 month after surgery in group B was significantly higher than that in group A (P<0.05). 11 patients in group A and 13 patients in group B had poor pain relief on the second day after surgery. There was no significant difference in VAS and ODI between the two groups at 2 weeks, 1 month, and 6 months after PVP. There was no significant difference in collapse rate and re-fracture rate between the two groups. Conclusion: In summary, in terms of postoperative quality of life and complications, postoperative braces did not improve the prognosis. The presence or absence of a brace cannot relieve residual pain after surgery. In contrast, a brace at 3 weeks after surgery reduced the quality of life in the short term. Keywords: percutaneous vertebroplasty, osteoporotic vertebral compression fracture, brace

Osteoporotic vertebral compression fractures (OVCF) usually cause severe back pain, lack of sleep, kyphosis, decreased quality of life, and increased risk of age-adjusted mortality. 1-3 In addition to anti-osteoporosis treatment, conservative treatment includes analgesics, passive physical therapy, bed rest, or use of a brace. 4 Percutaneous vertebroplasty (PVP) is an effective treatment for patients with surgical indications. 5 It can significantly reduce pain, reduce bedtime, and prevent deformities caused by collapse. 6 Previous studies have focused on surgical methods, non-surgical methods, and surgical complications. Some studies have reported that the incidence of collapse of the same vertebra after PVP or percutaneous kyphoplasty (PKP) is 3.21%-10%, and it mainly occurs in the first few months after surgery. 7,8 Some doctors suggest that patients should wear PVP and use a spinal brace to prevent vertebral collapse, osteonecrosis and back pain. 9-11 To our knowledge, there are no reports confirming whether the cement-enhanced brace can provide additional clinical benefits. In this study, we evaluated the effectiveness of the brace after PVP.

Study patients were admitted to the hospital between January 2017 and March 2018. Inclusion criteria include: 1) single-layer OVCF, 2) PVP treatment through unilateral access, 3) bone mineral density (BMD) 2.5 or lower, and 4) use of anti-osteoporosis drugs during follow-up. Exclusion criteria include: 1) history of malignancy, infection or tumor; 2) history of trauma; 3) PVP or PKP before OVCF; 4) bone cement does not touch the upper and lower end plates; 5) OVCF has intervertebral fissure, and 6) use Steroid patients.

We confirm that all methods are carried out in accordance with the relevant guidelines and regulations of the ethics committee of Xi’an Red Cross Hospital. We confirm that all experimental protocols have been approved by the ethics committee of Xi’an Red Cross Hospital. All procedures involving human participants in this study are in compliance with the institutional research committee’s ethical standards and the 1964 Helsinki Declaration and its subsequent revisions or similar ethical standards . In this study, written informed consent was obtained from all patients.

PVP is the injection of polymethylmethacrylate (PMMA) bone cement (Mendec Spine Resin; Tecres SPA, Andrea Doria, Italy) and unilateral transverse process Carried by Archer. 12 The operation was performed independently by three different surgeons.

Allow to get out of bed 6 hours after the operation. The patient was discharged 3 days after surgery. Some previous studies recommend wearing a spinal brace for 4-8 weeks after PVP, and there is no exact time to wear a brace after PVP in any treatment guidelines. 9-11 Based on our clinical experience and previous research, we believe that PVP may no longer be beneficial for a long time after PVP, so we only choose 3 weeks as the support period after surgery. All patients admitted before December 2017 used a rigid brace for 3 weeks after surgery (Figure 1). From January 2018, it is not recommended to use the brace after PVP. Anti-osteoporosis drugs (including calcium carbonate, calcitriol, and alendronate) should be prescribed for at least 6 months after surgery. Instruct all patients to exercise their back and abdominal muscles for 4 weeks after being discharged from the hospital.

Figure 1 The spinal brace (thoraco-lumbosacral orthosis) used in this study can be adjusted according to the patient's height and weight (red arrows indicate the front and head sides).

Record and compare the demographic and surgical data of the two groups. The visual analogue scale (VAS) and vertebral compression ratio (VCR) were recorded and compared before operation, on the second day after operation, 2 weeks, 1 month, and 6 months after operation. Also recorded and compared the adjusted Oswestry Disability Index (ODI; sex part not included) at the same time point. Postoperative residual pain is defined as pain relief (VAS) <50% on the second day after surgery. In order to evaluate the efficacy of the PVP brace for patients with postoperative residual pain, an additional separate analysis was performed on patients with postoperative residual pain. The rate of vertebral body collapse was compared between the two groups at 6 months postoperatively. Record any related postoperative complications. VCR is defined as the ratio of the height of the vertebral body before and after the injury level. 13 Taking into account the measurement error, surgical vertebral body collapse is defined as the difference between the final anterior body height and the postoperative anterior body height exceeding 2.0 mm. 9 VCR and collapse rate were independently measured by two co-authors (Dr. Fan and Dr. He), and then The results are averaged. During the follow-up period, re-fractures were recorded and defined as severe back pain in patients whose new spinal fractures were confirmed by magnetic resonance imaging during the follow-up period.

Age, gender, VAS, ODI, BMD, and body mass index are set as independent variables, and they are paired at a ratio of 1:1 through propensity matching. The normal distribution of the relevant data is determined by the Kolmogorov-Smirnov test, and the homogeneity of variance is tested by the Levene test. Perform paired t test and independent sample t test. A chi-square test was performed to compare fracture level, collapse rate, and gender. Use SPSS version 22.0 (SPSS Inc., Chicago, IL, USA) for statistical analysis. P<0.05 is considered statistically significant, and all P values ​​presented are two-tailed.

From January 2017 to December 2017, a total of 1256 patients with single-segment OVCF received PVP or PKP, of which 151 received bilateral PVP or PKP, 78 received long-term hormone therapy, 129 were lost to follow-up, and 120 patients had previous PVP Or PKP, 3 patients were diagnosed with multiple myeloma after surgery. Twenty-three patients refused to wear the brace after the operation, and 16 patients extended the brace due to waist discomfort at the time of removal. Finally, there were 736 patients in the historical control group; among them, 138 patients were paired into group B according to the propensity score, and there was no statistical difference in the baseline values ​​between the two groups (Table 1).

Table 1 Patient-related data Note: The data are expressed as mean ± standard deviation or numbers. Abbreviations: BMD, bone mineral density (waist and left hip); BMI, body mass index; ODI, Oswestry disability index; VAS, visual analog scale; VCR, vertebral compression ratio.

Compared with preoperatively, on the second day after operation, both groups of VAS and VCR were significantly improved (P<0.05). ODI, VAS, and VCR were significantly improved at 2 weeks, 1 month, and 6 months after PVP compared with those before operation (P<0.05). The ODI of group B was significantly higher than that of group A one month after operation (P<0.05, Table 2). There was no significant difference in ODI between the two groups at 2 weeks and 6 months after operation (P>0.05). There was no statistically significant difference in VAS or VCR between the two groups at 2 weeks, 1 month, and 6 months after PVP (P>0.05).

Table 2 Clinical and radiological results Note: The data are shown as mean ± standard deviation or numbers. *Statistical significance. Abbreviations: ODI, Oswestry Disability Index; VAS, visual analog scale; VCR, vertebral compression ratio.

No bone cement leakage leads to serious surgical complications such as postoperative neurological deficits or pulmonary embolism. We did not evaluate respiratory function in the study, but four patients in group B complained about the brace for respiratory reasons. 11 cases in group A and 13 cases in group B complained of obvious low back pain on the second day after operation. The 24 patients were given celecoxib for pain relief, and the pain was significantly reduced at the last follow-up. There was no significant difference in VAS and ODI between the two subgroups at 2 weeks (Table 3). There was no significant difference in the collapse rate and re-fracture rate between the two groups, as shown in Figure 2 and Table 2.

Table 3 Clinical results of patients with postoperative residual pain Note: Data are expressed as mean ± standard deviation. Abbreviations: ODI, Oswestry Disability Index; VAS, visual analog scale; VCR, vertebral compression ratio.

Figure 2 Comparison of the two groups of ODI, VAS, and VCR. Abbreviations: ODI, Oswestry Disability Index; VAS, visual analogue score; VCR, vertebral compression ratio; operation, operation.

Since the enhancement of PVP and PMMA were reported in 1987, PVP has been widely promoted as an effective treatment technique for OVCF. 14 In this study, compared with the preoperative values, the two groups of VAS, ODI and VCR achieved significantly satisfactory results. This is consistent with previous literature. 6,15 Research in recent years has focused on bone cement leakage, re-fracture of adjacent vertebrae, and vascular and/or nerve damage. However, after consulting some related literature, the descriptions of using brace for early recovery after PVP or PKP are different. Although the literature recommends the use of a brace after cement reinforcement, the time for bracing ranges from 4 to 8 weeks. 9-11 Whether the post-PVP brace can prevent postoperative complications and improve the quality of life remains unclear. According to previous studies, risk factors such as BMD, intervertebral fissure, and bone cement volume are related to vertebral body collapse, osteonecrosis after PVP, and postoperative satisfaction. 16,17 Of course, OVCF and intervertebral fissure are an important indication for surgical treatment. Due to the small sample size of patients who do not use a brace after intervertebral fissure PVP, they were not included in the study. We will discuss this in future studies. topic. In order to reduce the bias of this retrospective study, a control group based on propensity score matching (group B) was included. There was no statistical difference in baseline parameters between the two groups (P>0.05).

The brace has been widely used in the treatment of thoracolumbar fractures with or without surgical stabilization. In theory, a spinal brace can relieve pain, provide stability to the fracture site, reduce bedtime, and prevent further kyphotic collapse. 18 The results of this study showed that there was no significant difference in VCR between the two groups at 2 weeks, 1 month, and 6 months after surgery, and there was no significant difference in the collapse rate. In addition, we have observed that most patients lose a bit of vertebral height due to the permission to walk on their own, but this phenomenon does not cause discomfort. Although the brace has proven to be an effective method for the treatment of certain thoracolumbar fractures in many cases19, OVCF itself is a stable fracture, especially after the cement is strengthened, the local stability has been achieved. 20 In some diseases, the brace may restrict spinal movement, but this does not mean that the brace can provide additional benefits for relatively stable patients, as confirmed by previous studies focusing on cervical and lumbar surgery. 21,22 Even in patients with juvenile idiopathic scoliosis, postoperative braces are not required after internal fixation. 23 Although some studies have reported the use of braces after PVP or PKP, there is no evidence that additional external fixation is beneficial. A prospective randomized controlled study by Kim et al. showed that for conservative treatment of OVCF, the progression of precursor compression, improvement of back pain, and ODI without a brace are not inferior to those who use soft or hard braces . 13 The results reported by Bailey et al. are consistent with this finding. 24 In our study, there was no statistical difference in VAS between the two groups on the second day, 2 weeks, 1 month, and 6 months after PVP (P>0.05). There was no significant difference in ODI between group A and group B at 2 weeks and 6 months after operation (P>0.05). According to the results of a retrospective study, the postoperative brace did not improve the outcome of cervical and lumbar spine surgery. 25 A retrospective study found that internal fixation in spinal surgery can achieve rigid internal stabilization of cervical and lumbar spine surgery, and reduce the requirements for cervical and lumbar spine surgery. Externally fixed. As expected, since the patient did not benefit from the additional external fixation, the back pain caused by OVCF may be the main factor affecting daily life and ODI, and the operation relieved the pain almost immediately.

The ODI of group B was significantly higher than that of group A one month after operation. Group B scores higher, especially sitting, standing, and walking. It is likely that the core muscle atrophy in group B due to prolonged bracing will cause back pain and discomfort, thereby reducing the quality of life. The study also emphasized that braces have some shortcomings and should be monitored more vigilantly in the elderly, because braces may cause muscle atrophy, breathing disorders, skin irritation and additional costs. 13,18 However, 6 months after surgery, there was no significant difference in ODI between the two groups, which may be related to the strengthening of the core muscles by back and abdominal muscle exercises.

The results showed that even in patients with significant pain after the operation, there was no significant difference in VAS and ODI between the two groups on the second day, 2 weeks, 1 month, and 6 months after PVP (P>0.05). In group B Four of the patients did complain about the brace for respiratory reasons. Kato et al. also found that for OVCF, the use of a brace can have a negative impact on the respiratory function of patients with spinal disease. 26 The results also showed that there was no significant difference in re-fracture rates. As far as we know, there is no reliable research showing that the brace can reduce the rate of re-fracture after surgery. We initially assumed that a short-term brace would not change the local biomechanical environment for a long time, and a long-term brace may cause trunk muscle atrophy, so it may even increase the rate of re-fracture. If patients with re-fractures resist conservative treatment or dissatisfied with pain relief after 2 to 3 weeks of conservative treatment, PVP/PKP should be considered, and anti-osteoporosis drugs (including calcium carbonate, calcitriol, and alendronate) should be given at least 6 months. According to our results, studies have shown that the brace does not improve the quality of life and the height of the vertebrae; in addition, the presence or absence of the brace does not reduce postoperative residual pain.

Our research has several limitations. First, since this is a retrospective study, a large randomized prospective controlled trial is needed to verify our results. Second, a follow-up of only 6 months after surgery may not be enough to compare the effectiveness of braces. Finally, the operation is performed by three different surgeons, and differences between the operators may affect the results.

In short, in terms of postoperative quality of life and complications, postoperative braces did not improve the prognosis. The presence or absence of a brace does not relieve residual pain after surgery. In contrast, 3 weeks after surgery, the brace reduced the quality of life in the short term.

No funds have been received to support this work. Business parties directly or indirectly related to the subject of this manuscript have no or will not receive any form of benefit.

The authors report no conflicts of interest in this work.

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