|
 
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| ORIGINAL ARTICLE |
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| Year : 2023 | Volume
: 6
| Issue : 2 | Page : 157-163 |
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Percutaneous transpedicular vertebroplasty using calcium phosphate cement for osteoporotic vertebral fractures: A prospective study of functional outcomes
Swapnil Priyadarshi, Vikas Singhal, Sameer Gupta
Department of Orthopaedics, Gajra Raja Medical College, Gwalior, Madhya Pradesh, India
| Date of Submission | 15-Oct-2022 |
| Date of Decision | 26-Dec-2022 |
| Date of Acceptance | 27-Dec-2022 |
| Date of Web Publication | 3-May-2023 |
Correspondence Address:
Swapnil Priyadarshi
Sushila Hospital, Mohanpur Road, Samastipur - 848 101, Bihar
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jodp.jodp_99_22
Context: Vertebral compression fractures are the most common osteoporotic fracture in old age group causing incapacitating pain and producing significant disability. Approximately one-third of these patients do not respond to traditional conservative treatments. Percutaneous vertebroplasty (PV) is a minimally invasive treatment option being increasingly used and traditionally being done using polymethyl methacrylate (PMMA), but it has some disadvantages. Calcium phosphate cement (CPC) is a new entity with many benefits over PMMA such as it being biodegradable, little or no heat generation during polymerization, and remodeling into healthy bone. Aims: The aim of this study was to analyze the functional outcome, restoration of wedge angle, and vertebral height after vertebroplasty in osteoporotic vertebral wedge compression fractures. Subjects and Methods: In our study, a total of 21 symptomatic patients (between 55 and 80 years of age), refractory to conservative treatment, having kyphosis and vertebral wedge collapse were included in the study. Pre- and postoperative comparisons were done clinically (Oswestry Disability Index and Visual Analog Scale [VAS] score) and radiologically. Statistical Analysis Used: SPSS software version 22.0 was used for statistical analysis. Results: Preoperatively in all patients, Oswestry disability score was >60% and VAS score >7 indicating severe disability. On subsequent follow-ups at 15 days, 1 month, 3 months, 6 months, and 9 months, we found a significantly reduced VAS score (<2) and Oswestry disability score (<20%) in 19/21 (90%) patients indicating very minimal residual disability in majority of the patients. Conclusions: Our study shows that PV using CPC is a promising new procedure with the benefits of quick improvement in mobility, decreased pain-related doctor visits, decreased nonsteroidal anti-inflammatory drugs usage postoperatively, and overall increased quality of life.
Keywords: Biodegradable bone cement substitutes, calcium phosphate cement, osteoporosis, polymethyl methacrylate, vertebral compression fractures, vertebroplasty
How to cite this article:
Priyadarshi S, Singhal V, Gupta S. Percutaneous transpedicular vertebroplasty using calcium phosphate cement for osteoporotic vertebral fractures: A prospective study of functional outcomes. J Orthop Dis Traumatol 2023;6:157-63 |
How to cite this URL:
Priyadarshi S, Singhal V, Gupta S. Percutaneous transpedicular vertebroplasty using calcium phosphate cement for osteoporotic vertebral fractures: A prospective study of functional outcomes. J Orthop Dis Traumatol [serial online] 2023 [cited 2023 Jun 4];6:157-63. Available from: https://jodt.org/text.asp?2023/6/2/157/375557 |
| Introduction | |  |
Osteoporosis is the most prevalent bone ailment in the elderly population; one in three women and one in five men over the age of 50 may suffer an osteoporotic fracture during their lifetime.[1],[2] Vertebral compression fractures (VCFs) are the most common osteoporotic fracture in old age which cause excruciating pain and has a substantial impact on morbidity and disability.[3] Due to the typical wedge-shaped collapsing pattern, osteoporotic VCFs (OVCFs) result in persistent discomfort, unbalanced kyphosis, and loss of sagittal balance. Additionally, it leads to insomnia, sadness, major restrictions in everyday activities, and a shorter life expectancy, all of which have a considerable negative impact on the health-care system.[4]
VCFs are currently treated in one of three ways: (a) traditional conservative methods of care, (b) standard surgical procedure, (c) minimally invasive procedures (vertebroplasty/kyphoplasty).
Polymethyl methacrylate (PMMA) is currently the most widely utilized injectable bone cement which can be used to increase vertebral stiffness due to its low viscosity and superior injectability. In comparison to PMMA, calcium phosphate hydroxyapatite bone cement (which included calcium phosphate cement [CPC] powder as a pure nanocrystalline hydroxyapatite polymer and a liquid monomer as an additive) has many advantages, including being biodegradable, biocompatible, osteoconductive, producing little to no heat during polymerization, being well suited for injection, and remodeling into healthy bone.[5]
Why this study was conducted?
In our examination of the literature on OVCFs, we discovered that there are relatively few reports in our country on the outcome of vertebroplasty in these fractures. Therefore, we decided to conduct this study to investigate the impact of percutaneous vertebroplasty (PV) on Indian patients.
Aims and Objectives
The aims and objectives of this study were to analyze; functional outcome, disability index, to asses restoration of wedge angle and vertebral height augmentation after vertebroplasty in OVCFs.
| Subjects and Methods | | |
Study center
This randomized interventional prospective study was done from February 2020 to May 2021 after approval from the Institutional Ethics Committee.
Sample size
A total of 21 patients (16 females and 05 males) having 26 individual collapsed vertebrae were taken up in the study. The age of the patients was in the range of 55–80 years.
Inclusion criteria
- Painful OVCF >4 weeks and <5 months old, refractory to conservative treatment
- Regional kyphotic Cobb angle >15°
- VCF with vertebral compression >25% but <80% (Genant's classification Grade 2 and Grade 3 up to 80%).
Exclusion criteria
- Refusal to consent
- Responding to conservative treatment
- Local/systemic infection
- Coagulopathy
- Posterior cortex breach (decision taken based on magnetic resonance imaging [MRI] and computed tomography [CT] scan reports)
- Cord compression and neurological deficit
- Vertebra plana
- VCF with vertebral compression >80% (Genant's classification Grade 3)
- Significant cognitive impairment
- Spinal cord narrowing due to retropulsed fragment.
Methods
The patients with OVCFs were initially treated conservatively for 1–2 weeks using analgesics and bracing. After admission, a detailed history was obtained and attention was given to local examination of spine. Neurological charting included assessment of motor, sensory, bowel, and bladder status. In all patients, preoperative Visual Analog Scale (VAS) score for backache and Oswestry Disability Index (ODI) were noted for the purpose of comparison and evaluation of postoperative functional outcome.
Regional kyphotic Cobb angle, anterior vertebral wedge angle, anterior and posterior vertebral height, and vertebral body compression ratio (VBCR) were radiologically evaluated (using X rays, CT scan, and MRI) for deciding the type of intervention and for further follow ups. [Figure 1] shows radiological evaluation of kyphosis and vertebral height.[6] (a) Anterior VBCR = AVH/PVH, (b) Wedge angle (VBCR: Vertebral body compression ratio, AVH: Anterior vertebral height, PVH: Posterior vertebral height). Classification of fracture was done based on Genant's classification. | Figure 1: Radiological evaluation of kyphosis and ver tebral height.[6] (a) Anterior VBCR = AVH/PVH, (b) Wedge angle
Click here to view |
Surgical procedure
Under general anesthesia, percutaneous transpedicular vertebroplasty using CPC injection was done with fluoroscopic guidance. The needle was placed finally into the vertebral body at the junction of posterior two-third and anterior one-third in the lateral fluoroscopic view and in ipsilateral half of vertebral body in AP fluoroscopic view [Figure 2]. Intraosseous venography was done to detect any direct communication of needle tip with intraosseous vascular system of vertebral body and any extraosseous leakage of dye. | Figure 2: Final needle position: (a) In AP view needle at ipsilateral half of vertebral body (b) In lateral view needle at anterior 1/3rd of vertebral body. AP: Anteroposterior
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Cement preparation and cementation
Vertebroplasty CPC was prepared by mixing powder (polymer) and liquid (monomer) for around 1–2 min and then 3 ml volume was transferred to luer lock syringe. Once cement became of toothpaste-like consistency, we injected cement slowly into vertebral body under fluoroscopic guidance over the next 3–5 min [Figure 3].
Postoperative protocol
In postoperative period, the patient was monitored for vital signs, neurological status, VAS score, and ODI. The patient was discharged after 48 h of procedure and was advised to take oral antibiotics, analgesics, calcium and Vitamin D3 supplementation, and ibandronic acid and wear bracing as a precautionary measure. The patient was advised to gradually increase the daily activities of living as calcium phosphate achieves maximum strength at 1 week after injection. Patients were followed up at 2 weeks, 1 month, 3 months, and 6 months and assessed clinically (VAS and ODI) and radiologically (using X-rays/CT/MRI) [Figure 4] and [Figure 5]. | Figure 4: Single-level vertebroplasty (L1 vertebrae). (a) Preoperative CT scan, (b) CT scan at 6 months postoperative. CT: Computed tomography
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 | Figure 5: Single-level vertebroplasty (L3 vertebrae). (a) Preoperative CT scan, (b) postoperative CT scan. CT: Computed tomography
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| Results | | |
The mean age of cases in our study was 66 years. There were 76.2% of females and 23.8% of males, showing female preponderance. 90.5% of cases presented between 2 and 4 months after injury/illness. Majority of the cases (71.4%) had insidious onset of symptoms and only 28.6% of cases gave a history of trivial trauma leading to symptom onset.
Around two-third of cases had vertebral collapse at single level and the remaining one-third at multiple levels. Out of 27 individual vertebrae having osteoporotic collapse, 14 (51.8%) were at thoracolumbar junction (D12 and L1 vertebral level). Out of 27 individual vertebrae having osteoporotic collapse, 14 (51.8%) were at thoracolumbar junction (D12 and L1 vertebral level). However, out of these 14 individual vertebrae of the patients having vertebral collapse at D12/L1 junctional region, one of these patients was not given anesthesia fitness due to high cardiac risk, so she was not operated upon. Hence, even though that patient was initially included in the study, the final functional outcome analysis and follow-up was not done in that patient.
In total, 16 cases underwent single-level vertebroplasty and 5 cases underwent two-level vertebroplasty. In 21 cases selected for study, a total of 26 individual vertebrae were operated, out of which 13 vertebrae were D12/L1 vertebra (dorsolumbar junction) [Figure 6]. Cement injection using unipedicular approach was done in 91.5% of cases, and the mean amount of CPC used was 3 ml per vertebra. In most cases, the duration of surgery was <40 min. | Figure 6: Graph showing level of spinal tenderness, collapsed vertebra, and operated vertebra
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In our study, the mean preoperative VAS score was 7.86 which decreases to 4.76 in immediate postoperative period. The VAS score at subsequent follow-up at 2 weeks, 1 month, 3 months, and 6 months was 3.52, 2.48, 1.57, and 1.43, respectively, which suggested a gradual but significant difference postoperatively. A statistically significant decrease in VAS score was found on comparing immediate postoperative VAS score with 1 and 6 months postoperatively (P < 0.05). On comparing VAS score at 3 months with 6 months postoperatively, we found no significant difference (P > 0.05) [Figure 7].
In our study, the mean preoperative ODI was 72.14 which decreases to 40.29 in immediate postoperative period. ODI at subsequent follow-up at 2 weeks, 1 month, 3 months, and 6 months was 28.86, 23.57, 19.09, and 16.81, respectively, suggesting gradual improvement in disability. A statistically significant difference was also found on comparing ODI at immediate postoperative and 1- and 3-month postoperative periods with ODI at 6 months postoperatively (P < 0.05) [Figure 8].
For the evaluation of local vertebral kyphosis, anterior vertebral wedge angle was calculated. The difference in mean anterior vertebral wedge angle at various time periods during follow-up after vertebroplasty was statistically insignificant (P > 0.05). Similarly, for the evaluation of vertebral height restoration, VBCR was calculated. The difference in mean VBCR at various time periods during follow-up after vertebroplasty was statistically insignificant (P > 0.05) [Figure 9] and [Figure 10]. | Figure 9: Graph showing mean anterior vertebral wedge angle at different time periods
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 | Figure 10: Graph showing mean vertebral body compression ratio at different time periods
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In our study, we had no complications in 17 (81%) cases, asymptomatic cement leakage into epidural space in 3 cases, and 1 patient developing new-onset radicular back pain 4 months after procedure. None of the cases had any major complications.
| Discussion | | |
OVCF is a major public health problem in the elderly and is considered a silent epidemic. Pain due to VCFs often lasts for 4–6 weeks as the bone heals and then, in many cases, begins to subside in the following months. Singh et al.[7] in their study on OVCFs found that the frequency of patients having back pain of 1–6-month duration was maximum. Regular follow-up of the patients during this time should be done, because many symptomatic VCFs can turn asymptomatic over time, and just opposite to this, many asymptomatic but incidentally diagnosed cases can turn symptomatic due to further collapse of vertebra. If the pain is not relieved in the due course of time till the acute fracture heals, then options of vertebroplasty and kyphoplasty should be suggested.
Wu et al.[8] concluded that majority of VCFs have an insidious onset and may produce only low-grade back pain, and over time, multiple fractures may lead to progressive kyphosis and intractable back pain due to continuous contraction of the paraspinal muscles to maintain posture. Cooper et al.[9] and Patel et al.[10] have estimated that about 50% of clinical VCFs occur without any apparent fall or other obvious trauma.
In our study, most of the collapsed vertebrae were found to be at thoracolumbar junction which is similar to what is reported in various studies like a study done by Nakano et al.,[11] in which out of 40 vertebras with OVCFs, 27 vertebras were of the thoracolumbar junction (12 at T12 and 15 at L1). The thoracolumbar junction is a transitional zone between the more rigid thoracic vertebral column and the relatively mobile lumbar vertebral column which makes it more prone to fractures than the rest of the spine.
Singh et al.[7] performed 50 procedures via transpedicular route, out of which 6 (12%) procedures via bipedicular and 44 procedures (88%) via unipedicular approach. The authors found that more amount of cement was injected in bipedicular approach. The amount of pain relief from bipedicular approach as compared to unipedicular approach was found to be insignificant (P = 0.4) in relief of pain. They also inferred that although bipedicular approach has better lesion filling, unipedicular approach has several advantages like it is less time-consuming and associated with less complications, which is consistent with the findings of our study.
Mathis et al.[12] found more incidence of epidural leak when a larger volume of cement is injected in OVCFs and concluded that small volume of cement, in the range of 2.5–4.5 mL, is all that is required in order to restore vertebral body strength as shown in biomechanical studies. Correlation has not been clearly established between injection volume and clinical outcome in various studies. The mean amount of injected cement varies in different studies mostly from 1.5 to 5.3 ml. In our study, the mean value is 3 ml, which is within the range stated by others.
In a study by Ishiguro et al.,[13] the mean operating time was 30 (range: 20–40) min which is comparable to duration of surgery in our study, suggesting that PV is a short-duration day-care procedure which is very convenient to the patient.
Currently, the primary indication for PV is relief of vertebral fracture pain. While partial or very minimal vertebral height restoration can be achieved initially with vertebral augmentation procedures, doing so has not been shown to result in improved post-VCF clinical outcomes or reduced post-VCF morbidity. In a study by Ishiguro et al.,[13] the mean preoperative kyphosis index (same as VBCR) and deformity angle (same as Anterior vertebral wedge angle) were 66% and 15°, respectively, which improved to 89% and 4° immediately after surgery (P < 0.0001), but at 1-month follow-up, there was a correction loss and the values regressed significantly to 77% and 10°, respectively (P = 0.004 and 0.0004, respectively). The values were unchanged at the 1-year follow-up and compared favorably than those measured preoperatively (P = 0.0003 and P < 0.0001, respectively, with the mean improvement of just 9% and 4°, respectively. Furthermore, at the 1-month follow-up, patients in the vertebroplasty group retained a significantly better kyphosis index and deformity angle than those treated conservatively (P < 0.0001). Nakano et al.,[14] Nakano et al.,[15] and Nakano et al.[16] concluded that the preoperative VB kyphosis rate and deformity tended to improve minimally just after surgery, but the deformity reappeared at the 6-month follow-up. At the final follow-up visit in these studies, the mean kyphosis rate was similar to preoperative levels. These studies suggest that although initially the height of the vertebral body and kyphosis rates might improve, this improvement was lost with the passage of time. The authors also suggested to use a higher powder/liquid ratio of the injected CPC to achieve good correction. Hiwatashi et al.[17] concluded that minimal vertebral body height often increases during vertebroplasty, but clinical significance of increasing vertebral body height is unknown. In the short-term (6 months) analysis after vertebroplasty, we found that even though there were no significant changes in local kyphosis and vertebral height restoration, the final functional outcome regarding pain relief and disability improvement was excellent and did not correlate to vertebral height or kyphosis restoration. Furthermore, no further reduction in vertebral height (postprocedure) was noted in our study.
Ishiguro et al.[13] compared PV using CPC versus conservative treatment (control group) for OVCFs. The mean visual analog score for pain decreased significantly from preoperation to 1 day after surgery, 9.3 versus 6.2 (P = 0.02), and further decreased to 2.8 (P = 0.04) on day 3 or 4 when ambulation began, and to 1.5 at the 1-month follow-up and 1.4 at the final follow-up (mean: 14 months). The mean duration of analgesic treatment was also significantly lower (10.2 vs. 63.5 days, P = 0.003). Further, in a separate study by Nakano et al.,[16] the mean preoperative VAS score was 8.5. The mean VAS score immediately after surgery decreased to 3.68 (P < 0.0001). The mean VAS scores were 5.2, 3.3, and 3.3 at the 6 and 12-month follow-up examination and at the final follow-up visit (range, 24–60 months), respectively (P < 0.0001). In all patients without new OVFs, pain relief was maintained at the last follow-up. Some Indian studies also found similar results. Agrawal and Kothari.[18] noted that the average VAS in the preprocedure period was 8.3 which decreased in the postprocedure period at 2 weeks and 6 months to 2.6 and 3.6 subsequently, and at 1 year, the average VAS score was 4. No recurrence of pain and further vertebral collapse was seen during a mean follow-up of 1 year. The improvement in VAS score in our study corroborates very well with the various studies done in the past. PV has been shown to be effective in relieving pain associated with OVCF in patients who are inadequately treated with medication, bracing, and/or physical therapy. The pain relief is associated with a reduction in the use of analgesic medications and allows patients to return to their usual activities of daily living. Percutaneous transpedicular CPC-assisted vertebroplasty is a minimally invasive procedure that provides immediate or early relief of pain and yields better clinical and radiological results than conservative treatment for primary OVCF.
Karmakar et al.[19] observed that disability, measured by ODI score, significantly decreased (P < 0.05) over time from 1 week to 12 months postoperatively. At presentation, ODI score was 93.01 which reduced to 76.84, 1 week after operation, and 16.23, 1 year after operation. Disability status improved from bedbound to minimal disability at 1 year of operation. Wong and McGirt[20] reviewed 74 studies (including one level I) of vertebroplasty for osteoporotic compression fractures. The authors found level I evidence that vertebroplasty provides superior pain control over medical management in the first 2 weeks, and level II–III evidence that within the 1st 3 months, there are superior outcomes in analgesic use, disability, and general health, and finally, level II–III evidence that by 2 years, there is a similar level of pain control and physical function. The improvement in disability during the various time intervals postprocedure as observed in our study is similar to many studies done previously.
Mathis et al.[12] observed that the overall complication rate that is associated with vertebroplasty is <1% in OVCFs and most leaks are local and asymptomatic. They noted that rarely when the cement encroaches upon a neural structure, it has the possibility of myelopathy or radiculopathy. Venmans et al.[21] observed that the most common event that occurs during vertebral augmentation procedures is cement leak, defined as extension of injected bone cement beyond the vertebral body margins. Nakano et al.[11] noted that there was a small amount of CPC leakage into the spinal canal in four cases (10%) and into the intervertebral disc in one case (2.5%). No patient presented with a neurologic abnormality, cement embolism, or infection. Ishiguro et al.[13] found that three patients (8%) had a small amount of CPC leaked into the paravertebral muscle but experienced no symptoms. They suggested that advanced patient age, female gender, high bone mineral density, a short interval from injury to surgery, and injection via the unipedicular route may increase the incidence of CPC leakage. Agrawal and Kothari[18] noted that extrusion of bone cement was common, especially when the fracture plane extended to the endplates or cortical surfaces. Extrusion may occur into the epidural space of the spinal canal, the neural foramen, the intervertebral disc space, or the paraspinal veins and lungs. Each pattern of extrusion carries distinct risks but in most cases is asymptomatic. Singh et al.[7] concluded that the rate of thromboembolic complications has been reduced considerably by the increased operator skills and the use of denser cements, and now, the complication rates are around 0.5%–1%. Eighteen percent of the patients had extension of cement into the IV-disc space but were asymptomatic with no long-term complications. Radiologically evident cement leakage was cited as the most common complication by all the studies, but a vast majority of these patients remained asymptomatic and small amount of cement leakage didn't produce any detrimental effect on patient's final functional outcome. However, very rarely pulmonary cement embolus and spinal cord injury due to cement extravasation was also reported. The incidence of cement leakage usually varied from 6% to 15%. In our study, the rate of minor complications was similar to those observed in various studies and there were no major catastrophic complications. In our study, even though cement leakage was present (in very few cases), it did not cause any symptomatic problems to the patient [Table 1].
One of the patients developed new-onset radicular back pain 4 months after the procedure which was diagnosed on MRI to be due to minor disc bulge at a different level than the vertebra on which vertebroplasty was done. In this patient's preoperative, we had only done X-rays and CT and not MRI which might be the reason that the asymptomatic disc bulge might have been missed, thus emphasizing the need of adding MRI as a preoperative evaluation tool in all the cases for proper patient selection and good functional outcome postprocedure.
| Conclusion | | |
We concluded that percutaneous transpedicular vertebroplasty using CPC is a promising new method with the advantages of rapid improvement in mobility, fewer pain related doctor visits, improved stature, and decreased usage of analgesics postoperatively in the treatment of OVCFs.
Acknowledgment
I would like to thank the Department of Orthopaedics, GRMC, Gwalior, for providing me the opportunity to do this research work.
Financial support and sponsorship
This study was financially supported by the Department of Orthopaedics, Gajra Raja Medical College, Gwalior, Madhya Pradesh, India
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10]
[Table 1]
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