Painful Osteoporotic Vertebral Compression Fractures Research Articles

Chronic Painful Osteoporotic Vertebral Compression Fractures (OVCFs) of Thoracolumbar Spine: Percutaneous Vertebroplasty versus Conservative Management among Egyptian Patients

Introduction Vertebral augmentation procedures are widely used today in treating Osteoporotic vertebral compression fractures (OVCFs) especially in acute and subacute fractures. However, percutaneous vertebroplasty for patients with chronic painful OVCFs has been less well studied. The purpose of this study is to compare the efficacy and safety of percutaneous vertebroplasty with conservative management for the treatment of chronic painful OVCFs in the thoracolumbar spine among Egyptian patients. Patients and Methods This prospective cohort study included 60 patients with chronic OVCFs (38 females, 22 males, mean age: 65.42 ± 8.63) who presented with severe back pain to the outpatient clinic during the period from October 2005 to December 2011. Twenty-eight patients were treated with percutaneous vertebroplasty (vertebroplasty group). Thirty two patients refused surgical treatment and constituted the control group (Conservative group). The inclusion criteria included: Chronic painful OVCFs (at least 3 months), at least 50 years old, T5 to L5, osteoporosis (T-score -2.5 or lower), Visual Analogue Scale (VAS) at least 5, and absence of neurological deficits. At presentation, all patients of both groups received back brace, analgesics, anti-osteoporosis therapy. All patients were evaluated with X-rays and CT scan, where Cobb angle and the anteroposterior height comparison (APHC) were measured. Overall pain and quality of life were assessed with the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI). Results All patients were followed for at least 12 months (range, 12 to 28). Statistical analysis of the demographic data of the two groups could not reveal any significant differences. At latest follow up, there was significant improvement in Cobb angle and APHC in vertebroplasty group compared with conservative group ( p < 0.05). Twenty nine patients (90.63%) showed complete union in the conservative group while all patients (100%) showed complete union in the vertebroplasty group at latest follow up. VAS and ODI were significantly better in vertebroplasty group than conservative group ( p < 0.05) at latest follow up. Cement extravasation into the disc occurred in 2 patients (5.41%), and into the paravertebral tissue in 3 (8.11%); none was associated with neurological symptoms, cement embolism, or infection. Recent fracture occurred adjacent to the formerly cemented ones in 2 patients (7.14%) and in non-adjacent level in one (3.57%). In conservative group, 3 patients (9.37%) presented with new osteoporotic vertebral fractures in adjacent levels and 2 (6.25%) in non adjacent levels. Three patients (9.37%) showed non union. Conclusion Percutaneous vertebroplasty is safe and effective in treatment of symptomatic chronic osteoporotic vertebral compression fractures with significantly better clinical and radiological outcomes when compared with conservative management.

Small cavity creation in the vertebral body reduces the rate of cement leakage during vertebroplasty.

Cement leakage is the most common complication during vertebroplasty and may result in serious morbidity. Measures to reduce the rate of cement leakage are valuable ways to improve vertebroplasty safety. The present study aimed to evaluate whether creating a small cavity in the vertebral body prior to cement injection would reduce the rate of cement leakage during vertebroplasty. The study included 36 consecutive patients with 42 painful osteoporotic vertebral body compression fractures that were classified as A1 fractures according to AO classification. Patients were randomly assigned to receive either treatment with vertebroplasty (control) or with a procedure termed cavuplasty, in which a small cavity was created in the vertebral body prior to cement injection. CT scanning was performed to detect cement leakage. Cement leakage was observed in 14 (66.6%) of the 21 vertebral bodies treated with vertebroplasty and 5 (23.8%) of the 21 vertebral bodies treated with cavuplasty (p = 0.012). These results suggest that the creation of a small cavity in the vertebral body prior to cement injection is an effective way to reduce cement leakage during vertebroplasty. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:154-159, 2017.

Cognizance on the re-fracture of the operated vertebra with cemented augmentation in osteoporotic vertebral compression fractures

One option with minimally invasive surgery for treatment of painful osteoporotic vertebral compression fracture is percutaneous vertebroplasty or percutaneous kyphoplasty via an inflatable balloon tamp followed by stabilization with polymethylmethacrylate cement. The vertebral height is restored and the decreased loading ability of the fractured vertebral body is restrengthened with pain relief. The effect of the method is widely demonstrated in those conditions. At the same time, the relative problems, such as the complications are being lucubrated and discussed. The reports on the re-fracture or height loss of the operated vertebrae with cemented augmentation are becoming more. By now, there are some unclear aspects on the problem: the definition of the re-fracture of the augmented vertebra is still unclear and not ascertained and the clinical manifestations are various. The mechanisms and correlative factors are still not clear-cut either. The rate of subsequent re-fractures after cemented augmentation from literature is fargoing, with a rate of 0% to 63%. The correlative factors on the re-fracture of the operated vertebrae chiefly include: osteoporosis, bone necrosis caused by the heat injury from cement solidification, failure to achieve endplate-to-endplate cement augmentation, intravertebral cleft or avascular bone necrosis, premature mobilization or excessive movement, overfull reduction of the vertebral height, the biological character of the spine column, and so on. Great controversy still exists on the correlation between those possible factors and the re-fractures. More attention should be paid to this problem to explore the true risk factors and mechanism, decrease the re-fracutre rate, and elevate the clinical outcome in osteoporotic compression fractures.

Vertebral Augmentation: State of the Art.

Osteoporotic vertebral compression fractures (OVF) are an increasing public health problem. Cement augmentation (vertebroplasty of kyphoplasty) helps stabilize painful OVF refractory to medical treatment. This stabilization is thought to improve pain and functional outcome. Vertebroplasty consists of injecting cement into a fractured vertebra using a percutaneous transpedicular approach. Balloon kyphoplasty uses an inflatable balloon prior to injecting the cement. Although kyphoplasty is associated with significant improvement of local kyphosis and less cement leakage, this does not result in long-term clinical and functional improvement. Moreover, vertebroplasty is favored by some due to the high cost of kyphoplasty. The injection of cement increases the stiffness of the fracture vertebrae. This can lead, in theory, to adjacent OVF. However, many studies found no increase of subsequent fracture when comparing medical treatment to cement augmentation. Kyphoplasty can have a protective effect due to restoration of sagittal balance.

Analysis of Risk Factors Causing New Symptomatic Vertebral Compression Fractures After Percutaneous Vertebroplasty for Painful Osteoporotic Vertebral Compression Fractures

A retrospective cohort study. New vertebral compression fracture (NVCF) is a highly potential risk after percutaneous vertebroplasty (PVP). The study aimed at analyzing the incidence and risk factors of NVCF and preventing its development. PVP is widely used and highly effective technique for reducing pain caused by an osteoporotic vertebral compression fracture. However, there is a great deal of debate about whether PVP is associated with NVCF, and many risk factors of NVCF have been hypothesized. From January to December 2008, a total of 198 patients (176 women, 22 men; mean age, 76.6±0.5 y) who underwent PVP at 270 levels for painful osteoporotic VCF were retrospectively analyzed during a 4-year follow-up. The following parameters were evaluated: NVCF incidence and average time, body mass index (BMI), smoking history, the existence of trauma, and bone mineral density (BMD) before and after PVP. Cement location, intradiscal leakage, distribution pattern, kyphotic angle, sagittal index, compression ratio, injected cement volume, and numbers of fractures and thoracolumbar junction fractures were analyzed. During follow-up, 34 patients (17.2%) sustained symptomatic NVCF for 4-year follow-up. All 34 patients with NVCF had lower BMD than that before initial PVP. For adjacent VCF, multivariable analysis showed that a higher risk of NVCF after vertebroplasty was associated with a larger number of VCF (P=0.025) and lower BMI (P=0.045), whereas for remote VCF, the risk of NVCF was higher in patients who had not experienced trauma and lower BMD (P=0.045). None of the radiographic evaluation values were related to the occurrence of NVCF. The most important elements related to reducing NVCF were treating osteoporosis and improving BMD and BMI. More aggressive BMD and BMI correction is more important than the vertebroplasty technique.

The prospective self-controlled study of unilateral transverse process-pedicle and bilateral puncture techniques in percutaneous kyphoplasty.

Many previous studies have reported excellent clinical results with percutaneous kyphoplasty (PKP). In contrast, numerous complications and problems have also been reported, such as puncture difficulty, cement leakage, and adjacent vertebral fracture. This study is to evaluate the application and clinical outcomes of unilateral transverse process-pedicle and bilateral PKP in the treatment of osteoporotic vertebral compression fractures (OVCF). A total of 56 cases with two levels thoracolumbar OVCF were randomly assigned for treatment with unilateral transverse process-pedicle and bilateral PKP. The patients were followed up postoperatively and were assessed mainly with regard to clinical and radiologic outcomes. Clinical outcomes were evaluated with mainly the use of a visual analogue scale (VAS) for pain. Radiologic outcomes were assessed mainly on the basis of radiation dose and bone cement distribution. The operation was completed successfully in 56 cases. In the unilateral level, the operation time, the volume of the injected cement, and radiation dose were significantly less than bilateral level. All patients had significantly improvement on VAS score after the procedures, compared with their preoperative period. In the bilateral level, 7 patients had obvious pain in the puncture sites at 1month postoperatively caused by facet joint violation. With local block treatment, the pain disappeared in all patients at the last follow-up. Both bilateral and unilateral PKP are relatively safe and effective treatments for patients with painful OVCF. But unilateral PKP received less radiation dose and operation time, offered a higher degree of deformity correction, and resulted in less complication than bilateral.

Results of Vertebral Augmentation Treatment for Patients of Painful Osteoporotic Vertebral Compression Fractures: A Meta-Analysis of Eight Randomized Controlled Trials.

BackgroundIn 2009 two RCTs were publicated to question the efficacy of vertebroplasty comparing with sham treatment (ST) in the New England Journal of Medicine (NEJM), which provoked an academic debate on the efficacy of PVA. The purposes of our study were to compare clinical differences in pain relief, spinal functional outcomes, and overall quality of life between PVA and CT for painful osteoporotic VCFs.MethodsWe searched PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and Web of Knowledge from January 1980 to June 2013 with Medical Subject Headings terms and keywords. Risk of bias in the included studies was assessed in accordance with the Cochrane risk of bias tool. In this Meta-analysis dichotomous and continuous variables were calculated using the risk ratio (RR) and standardized mean difference (SMD), respectively.ResultsEight studies involving 987 patients met the criteria for inclusion. The VAS SMD was favoring the experimental group significantly (p < 0.001). Subgroup analysis suggested that the patients performed PVA with mean fracture age less than 3 months would got pain relief earlier and more durable than the control group (P <0.05). The SMD of spinal function assessed with RDQ and Oswestry LBP data was in favor of the experimental groups. QOL outcome improvement was demonstrated statistically significant at early, middle and late-term follow-up for PVA than the control group (P <0.05).ConclusionsIn conclusion, this meta-analysis, which evaluated PVA for osteoporotic VCFs, demonstrated significant improvement regarding VAS, spinal function and QOL outcomes. The optimal fracture age was less than 12 weeks.

Efficacy of Percutaneous Vertebroplasty in the Treatment of Osteoporotic Vertebral Compression Fractures with Intravertebral Cleft.

Intravertebral cleft (IVC) is frequently observed in patients with painful osteoporotic vertebral compression fracture (OVCF). Some studies reported the usefulness of percutaneous vertebroplasty (PVP) for treating OVCF with IVC. However, systematic studies are scarce, and their results are conflicting. The purpose of this study was to evaluate the clinical and radiographic results of PVP in the treatment of painful OVCF with IVC. Two hundred ninety-one patients with OVCF with IVC underwent PVP. Back pain was measured using a visual analog scale (VAS), and physical disability was assessed using the Oswestry Disability Index (ODI). Three radiological parameters were assessed: the local kyphotic angle, percentage spinal canal cross-sectional area of compromise, and intravertebral instability of the affected vertebra. The mean follow-up period was 28 months. The mean values for the VAS and ODI were 8.4 and 60.0%, respectively, before PVP, versus 3.9 and 35.4%, respectively, at the final follow-up. The average local kyphotic angle, percentage spinal canal cross-sectional area of compromise, and intravertebral instability were 10.5°, 17.9% and 6.1°, respectively, before PVP and 8.1°, 15.2%, and 0.8°, respectively, at the final follow-up. There were no neurological or systemic complications due to cement leakage. PVP is an effective and safe intervention for treating OVCF with IVC.

Clinical comparative study of percutaneous kyphoplasty in treatment of acute and chronic and nonunion osteoporotic vertebral compression fractures and the operative opportunity

Objective Clinical comparative study of percutaneous kyphoplasty in treatment of acute and chronic and nonunion osteoporotic vertebral compression fractures and the operative opportunity. Methods Totally 91 elderly with osteoporotic thoracolumbar vertebral compression fractures were treated by PKP and divided into acute and chronic and nonunion fracture group, acute fracture group 59 patients,chronic and nonunion fracture group 32 patients, the surgical outcomes were evaluated by using visual analogue scale(VAS), Oswestry disability index(ODI)system, kyphosis angle(cobb method), the height of vertebrae body before and after 1 week, 3 months after surgery. Results All patients had rapid and significant improvement in back pain following percutaneous kyphoplasty.and followed 6- 12 and 3 months after surgery(P 0.05). The kyphosis angle(cobb method), the height of vertebrae body were improved significantly at 1 week and 3 months after surgery(P<0.05), and the acute fracture group was improved significantly than the chronic and nonunion fracture group(P<0.05). Conclusion The curative effect of percutaneous kyphoplasty for the treatment of acute painful osteoporotic vertebral compression fracture(POVCFs) and chronic and nonunion POVCFs was satisfactory, the kyphosis angle(cobb method), the height of vertebrae body for the acute fracture group were superior to than the chronic and nonunion fracture group(P< 0.05). Key words: Osteoporotic vertebral compressive fracture; Percutaneous kyphoplasty; Chronic; Nonunion; Operative opportunity

Chronic Painful Osteoporotic Vertebral Compression Fractures of Thoracolumbar Spine: Percutaneous Vertebroplasty versus Conservative Management among Egyptian Patients

Background Data: Vertebral augmentation procedures are widely used today in treating acute and subacute osteoporotic vertebral compression fractures (OVCFs). However, percutaneous vertebroplasty for patients with chronic painful OVCFs has been less well studied. Study Design: A prospective cohort study. Purpose: to compare the efficacy and safety of percutaneous vertebroplasty with conservative treatment for management of chronic painful OVCFs in thethoracolumbar spine among Egyptian patients. Patients and Methods: Ninety-eight patients presented with acute OVCFs during the period from October 2009 to December 2013. They were treated conservatively and followed for at least 3 months. Thereafter, 38 patients were excluded from this study as significant pain improvement was noticed in 32 patients and 6 didn't fulfill the inclusion criteria of this study. The remaining 60 patients (38 females and 22 males, mean age: 65.42±8.63) with chronic painful OVCFs were included in this prospective cohort study. Twenty-eight patients were treated with percutaneous vertebroplasty (Vertebroplasty group). Thirty two patients refused surgical treatment and constituted the control group (Conservative group). All patients were evaluated with X-rays and CT scan, where Cobb angle and the anteroposterior height comparison (APHC) were measured. Overall pain and quality of life were assessed with the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) respectively.Results: All patients were followed for at least 12 months. Statistical analysis of the demographic data of the two groups could not reveal any significant differences. At latest follow up, there was significant improvement in Cobb angle and APHC in Vertebroplasty group when compared with Conservative group (P=0.001). Three patients in the Conservative group (9.37%) went into nonunion, while all patients in the Vertebroplasty group showed radiological evidence of good stability at latest follow up. A significant improvement of VAS Scores (P=0.001) and ODI (P=0.001) was observed in theVertebroplasty group when compared to the Conservative group at the latest follow up. Conclusion: Percutaneous vertebroplasty is safe and effective in treatment of chronic painful osteoporotic vertebral compression fractures with significantly better radiological and clinical outcomes when compared with conservative management. (2015ESJ086)

Does balloon kyphoplasty improve the global spinal alignment in osteoporotic vertebral fracture?

Balloon kyphoplasty (BKP) has been a well-accepted procedure in the treatment of osteoporotic vertebral compression fracture (OVCF), whereas it remains unclear whether or not this procedure has an impact on the global spinal alignment. The purpose of this study is to evaluate the effect of BKP on the global spinal alignment in OVCF. Fifty-six consecutive patients who had undergone BKP for symptomatic OVCF were retrospectively reviewed with a mean follow-up of 32 months. They were seven males and 49 females with a mean age of 75 years. Radiographic assessment was performed using upright whole spine radiographs. The parameters included vertebral kyphosis, mid-vertebral body height and global sagittal spinal alignment (C7 plumb line deviation). Clinical outcomes were evaluated using visual analog scale of back pain. Fifty-one of 56 patients (91.1 %) achieved immediate pain relief. Vertebral kyphosis significantly decreased from 18 to 14 degrees, but 43 patients (76.8 %) still had more than 10 degrees of local kyphosis. Subsequent vertebral compression fractures were observed in seven patients (12.5 %). Anterior deviation of a C7 plumb line (C7PL) was 3.1 cm pre-operatively, 3.1 cm postoperatively, and significantly increased to 5.9 cm at the final follow-up. Consistent results were obtained in those with pre-operative sagittal imbalance (>5 cm anterior deviation of C7PL) and with pre-existing OVCFs. BKP contributed to immediate pain relief, but did not improve the global sagittal spinal alignment after OVCF. This procedure should be solely indicated for painful OVCF or non-union, and could not be expected to restore the global sagittal alignment.

Comparison of High-Viscosity Cement Vertebroplasty and Balloon Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures

Background: Percutaneous vertebroplasty is a widely used vertebral augmentation procedure for treating osteoporotic vertebral compression fractures (OVCFs). But high cement leakage rate caused by a low-viscosity cement and high injection pressure has limited its general use. Balloon kyphoplasty (BKP) and high-viscosity cement vertebroplasty (HVCV) are 2 modifications of vertebroplasty designed to decrease cement leakage. Objective: To assess the safety and efficacy of HVCV compared with BKP. Study Design: A prospective cohort study. Setting: Department of Spine Surgery, an affiliated hospital of a medical university. Method: One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups. Visual Analog Scale (VAS), Oswestry Disability Index (ODI), cement leakage, and vertebral height restoration were evaluated. All occurring complications and injected cement volumes were recorded. The follow-up time was one year. Results: VAS and ODI scores improved in both groups, and did not differ significantly between the 2 groups. More cement was used in the BKP group than in HVCV group (4.22 vs. 3.31 mL, P &lt; 0.0001). The incidence of cement leakage in the HVCV group was lower than that of the BKP group (13.24% vs 30.56%, P &lt; 0.05). No symptomatic cement leakages occurred in the HVCV group. In the BKP group, one patient experienced discogenic back pain related to a disc leak, and another patient had asymptomatic cement emboli in the lung related to venous leakage. The mean compression rate before the procedure was 29.98% in the HVCV group and 28.67% in the BKP group (P = 0.94). The vertebral height was improved significantly and maintained at one-year follow-up in both groups. BKP was more effective in vertebral height restoration than HVCV (44.87% vs. 23.93%, P &lt; 0.0001). There was one case of a new adjacent vertebral fracture in the HVCV group (2%), and 4 cases of new nonadjacent vertebral fractures in the BKP group (7.84%) (P = 0.18). Limitations: A single-center and relatively small-sample size study. Conclusion: HVCV and BKP are safe and effective in improving quality of life and relieving pain. HVCV has a lower cement leakage rate, whereas BKP is more effective in vertebral height restoration. Subsequent fractures are not different between the 2 groups. Key words: Vertebral compression fracture, spine, osteoporosis, cement augmentation, balloon kyphoplasty, vertebroplasty, cement leakage

Use and evaluation of a semi-permeable mesh implant in vertebral augmentation for the treatment of painful osteoporotic vertebral compression fractures

ObjectiveTo assess the efficacy of a semi-permeable mesh implant in the treatment of painful thoracic and lumbar osteoporotic vertebral compression fractures.MethodsPatients with painful thoracic and lumbar osteoporotic vertebral compression fractures...

Safety of balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures in Europe: a meta-analysis of randomized controlled trials.

The study aims to evaluate the safety of balloon kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures in Europe. Systematic review of the literature, until September 2013, and meta-analysis of randomized controlled trials performed in Europe assessing the safety of balloon kyphoplasty in patients with symptomatic osteoporotic vertebral fractures. Outcomes sought include cement leaks, serious clinical complications and new vertebral fractures. Six randomized controlled trials fulfilled the inclusion criteria. These studies included data on 525 treated levels in 424 patients. Cement leakages were detected in 18.3 % (95 % CI 11.6, 23.0) of fractures intervened. In about 0.5 % (95 % CI 0.1, 1.1) of fractures leakages proved to be symptomatic. Serious clinical complications were recorded in 11.5 % (95 % CI 1.1, 21.7) of patients treated with balloon kyphoplasty with several of these cases requiring intensive treatment or postoperative surgery. New vertebral fractures were detected in 20.7 % (95 % CI 0.4, 40.9) of patients treated but rates showed an upward pattern when the follow-up period increased. In 54 % of such cases, the fractures were located in regions adjacent to the treated level. The safety profile and associated complications of balloon kyphoplasty shown in this analysis, based on the evidence provided by existing randomized controlled trials, can be of help to the practicing clinician who must contrast them with the potential benefits of the technique. These data represent an important step towards a balanced evaluation of the intervention though, a better reporting and more reliable data on long-term assessment of potential sequelae are needed.

Kyphoplasty in the treatment of osteoporotic spine fractures - experience with 1069 cases

Kyphoplasty has been established as treatment for painful osteoporotic vertebral compression fractures for over ten years. Its effectiveness has been substantiated in multiple clinical studies. Not only is prompt pain reduction achieved, but according to a new, large, long-term study, long-term survival is also increased. Balloon kyphoplasty was performed for 1069 patients between 01.01.2008 and 31.12.2013. In all cases, pain was rated more than 6/10 points, and a recent fracture was evident on cross-sectional imaging (CT or MRT STIR T2) performed to supplement spine X-rays. Average patient age was 77 ± 5.2 years. 73 % of patients were female. Treated fracture levels ranged from T 3 to L 5. A single level was treated in 627 cases, two levels were treated simultaneously in 246 cases, three levels in 73 cases, and four levels in 29 cases. Average operative time for all patients was 35 minutes. Pain was reduced from 8.0 ± 1.0 preoperative to 2.2 ± 1.3 points postoperative in visual analogue scale (p < 0.1). Average intrahospital time was 9 days. Asymptomatic cement leckages were seen in 20 % of the cases. 855 were released home from the hospital and 210 patients went on to rehabilitation. Seven major complications (0.9 %) occurred during the hospital time (four mortalities during hospital admission, three neurological deficits, one lateral implant protrusion and a subdural bleeding). Kyphoplasty is a good procedure for treating painful osteoporotic fractures from the lumbar to the thoracic spine. Major complications occur rarely after kyphoplasty; however, they must be considered and clarified.

Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis

Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty (BKP) is a variation of this approach, in which an inflatable balloon tamp is placed in the collapsed vertebra prior to cement injection. To systematically evaluate and appraise the clinical effectiveness and cost-effectiveness of PVP and percutaneous BKP in reducing pain and disability in people with osteoporotic vertebral compression fractures (VCFs) in England and Wales. A systematic review was carried out. Ten databases including MEDLINE and CINAHL were searched from inception to November 2011, and supplemented by hand-searching relevant articles and contact with an expert. Studies met the inclusion criteria if they were randomised controlled trials (RCTs) including people with painful osteoporotic VCFs with a group receiving PVP or BKP. In addition, lead authors of identified RCTs were contacted for unpublished data. Primary outcomes were health-related quality of life; back-specific functional status/mobility; pain/analgesic use; vertebral body height and angular deformity; incidence of new vertebral fractures and progression of treated fracture. A manufacturer provided academic-in-confidence observational data indicating that vertebral augmentation may be associated with a beneficial mortality effect, and that, potentially, BKP was more efficacious than PVP. These data were formally critiqued. A mathematical model was constructed to explore the cost-effectiveness of BKP, PVP and operative placebo with local anaesthesia (OPLA) compared with optimal pain management (OPM). Six scenario analyses were conducted that assessed combinations of assumptions on mortality (differential beneficial effects for BKP and PVP; equal beneficial effects for BKP and PVP; and no effect assumed) and derivation of utility data (either mapped from visual analogue scale pain score data produced by a network meta-analysis or using direct European Quality of Life-5 Dimensions data from the trials). Extensive sensitivity analyses were conducted on each of the six scenarios. This report contains reference to confidential information provided as part of the National Institute for Health and Care Excellence appraisal process. This information has been removed from the report and the results, discussions and conclusions of the report do not include the confidential information. These sections are clearly marked in the report. A total of nine RCTs were identified and included in the review of clinical effectiveness. This body of literature was of variable quality, with the two double-blind, OPLA-controlled trials being at the least risk of bias. The most significant methodological issue among the remaining trials was lack of blinding for both study participants and outcome assessors. Broadly speaking, the literature suggests that both PVP and BKP provide substantially greater benefits than OPM in open-label trials. However, in double-blinded trials PVP was shown to have no more benefit than local anaesthetic; no trials of BKP compared with local anaesthesia have been conducted. A formal analysis of observational mortality data undertaken within this report concluded that it was not possible to say with certainty if there is a difference in mortality between patients undergoing BKP and PVP compared with OPM. Results from the cost-effectiveness analyses were varied, with all of BKP, PVP and OPLA appearing the most cost-effective treatment dependent on the assumptions made regarding mortality effects, utility, hospitalisation costs and OPLA costs. Data on key parameters were uncertain and/or potentially confounded, making definitive conclusions difficult to make. For people with painful osteoporotic VCFs refractory to analgesic treatment, PVP and BKP perform significantly better in unblinded trials than OPM in terms of improving quality of life and reducing pain and disability. However, there is as yet no convincing evidence that either procedure performs better than OPLA. The uncertainty in the evidence base means that no definitive conclusion on the cost-effectiveness of PVP or BKP can be provided. Further research should focus on establishing whether or not BKP and PVP have a mortality advantage compared with OPLA and on whether or not these provide any utility gain compared with OPLA. This study was registered as PROSPERO number CRD42011001822. The National Institute for Health Research Health Technology Assessment programme.

Outcome Comparison between Percutaneous Vertebroplasty and Conservative Treatment in Acute Painful Osteoporotic Vertebral Compression Fracture

Outcome Comparison between Percutaneous Vertebroplasty and Conservative Treatment in Acute Painful Osteoporotic Vertebral Compression Fracture

Vertebral Bone Drilling (Puncture) Attenuates the Acute Pain Due to Vertebral Compression Fractures

Purpose: The Investigational Vertebroplasty Efficacy and Safety Trial (INVEST), a randomized blinded controlled study of Vertebroplasty, demonstrated similar improvements in pain between blinded Vertebroplasty and sham-Vertebroplasty groups. The result from the RCT study suggested that the observed efficacy of the Vertebroplasty procedure, instead of representing the cement-mediated reduction in pain, may relate to the vertebral bone drilling per se. The aim of this study was to demonstrate the effectiveness of pain relief of vertebral bone drilling at the site of painful osteoporotic vertebral compression fractures in the acute phase. Materials and Methods: Twenty-six patients with painful osteoporotic compression fractures underwent the vertebral bone drilling. We assessed primary outcome measures in the NRS pain score and RDQ score at day 0 and 3 following the drilling. Comparisons were made by using Wilcoxon signed rank test. Results: The mean baseline NRS and RDQ score, and the mean NRS and RDQ score at day 3 were 7.3 ± 1.2, 15.7 ± 4.2, 4.6 ± 1.4, 7.3 ± 2.2, respectively. Among the patients, we detected significant improvements in NRS pain score and RDQ score at day 3 following the drilling compared with day 0 (P al compression fractures alleviated the intractable pain due to osteoporotic vertebral compression fractures.

Minimal-invasive Zementaugmentation von osteoporotischen Wirbelkörperfrakturen mit der neuen Radiofrequenz-Kyphoplastie

Minimally invasive cement augmentation of painful osteoporotic vertebral compression fractures in elderly patients. Painful osteoporotic vertebral compression fractures in elderly patients (> 65 years of age) after conservative therapy failure. Painful aggressive primary tumors of the spine or osteolytic metastases to the spine with high risk of vertebral fracture in the palliative care setting. General contraindications for surgical interventions. Local soft-tissue infection. Osteomyelitis, discitis or systemic infection. Coagulopathy refractory to treatment or bleeding diathesis. Asymptomatic vertebral compression fractures. Burst of the posterior vertebral column with high degree of spinal canal stenosis. Primary or metastatic spinal tumors with epidural growth. Prone position on a radiolucent operating table. Fluoroscopic localization of the fractured vertebra using two conventional C-arm devices (anteroposterior and lateral views). Fluoroscopic localization of the fractured vertebra using two conventional C-arm devices (anteroposterior and lateral views). An introducer is inserted through a small skin incision into the pedicle under fluoroscopic guidance. To create a site- and size-specific three-dimensional cavity in the center of the fractured vertebra, the navigational VertecoR™ MidLine Osteotome was inserted through the correctly sited introducer and guided fluoroscopically. As the MidLine Osteotome allows angulation of the tip up to 90° by rotating the handle, a cavity over the midline of the vertebral body can mainly be created through one pedicle. The radiofrequency activated cohesive ultrahigh viscosity PMMA cement (ER(2) bone cement) is injected stepwise on demand by remote control under continuous pressure from the hydraulic assembly into the vertebral body. Bed rest for 6h postoperatively in supine position. Early mobilization without a corset on the day of surgery. Specific back and abdominal exercises that strengthen the back and abdominal muscles. Pain dependent increase of weight bearing. Continue osteoporosis therapy and start specific drug therapy according to the local guidlines if necessary. In all, 44patients (29women, 15men) with a mean age of 73.5years with a total of 62painful osteoporotic vertebral fractures were treated with RF kyphoplasty from May 2009 until July 2010, and followed over a period of 12months. The mean operating time per patient was 36.2min, the operating time per vertebra was 25.7min. All the patients studied experienced an early and persistent significant pain relief even 12months after therapy (8 ± 1.4 vs. 2.7 ± 1.9) according to the visual analogue pain scale. According to the Oswestry Disability Index (ODI) as a disease-specific disability measure all the patients improved significantly (p < 0.001) in the level of disability after operative treatment (56.2 ± 18.8 vs. 34.5 ± 16.6). Cement leakage was detected in 17 out of 62 (27.4 %) augmented vertebrae, whereas all the patients with cement leakage remained asymptomatic. One patient had subsequent vertebral fractures after a period of 6months.

Vertebral Augmentation Versus Conservative Therapy for Emergently Admitted Vertebral Compression Deformities: An Economic Analysis

Background: Vertebral augmentation (VA) performed on inpatients with painful osteoporotic vertebral compression fractures (VCFs) has been shown to facilitate discharge, decrease analgesic requirements, and improve pain. Objective: The purpose of our study was to compare the overall cost, length of stay, and readmission data for patients hospitalized with painful osteoporotic VCFs, treated either medically or with inpatient VA. Setting: A single academic medical center. Study Design: Economic analysis Methods: Patients admitted with VCF over a 30-month period were identified using ICD-9 codes. The total length of stay, hospitalization costs, average daily cost, and 30-day readmission rates were compared between those who underwent VA and those managed nonoperatively. A subgroup analysis was performed with an age matched group of controls as well. Two-tailed t-tests were used for statistical significance. Results: Thirty-nine inpatients underwent VA; 61 levels were augmented. Their average age was 81.7 years. There were 209 patients who were treated nonoperatively for VCF. Their average age was 72.7 years, a significant age difference from the VA group (P &lt; 0.01). The VA patients’ average length of stay was 13.8 days, compared to 8.1 days in the medically managed group (P &lt; 0.01). Average total costs were $26,074 in the VA group and $15,507 in the medically managed group (P &lt; 0.01). The daily costs of admission were $2,040 in the VA group and $2,069 in the medically managed group (P = 0.85). The readmission rates related to VCF were 0% in the VA group; 5.2% in the medically managed group; and 7.7% in the agematched control group. Of those who underwent VA, 43% experienced delays in care related to anticoagulation or medical comorbidities. Limitations: The study is retrospective and uses billing data as a marker for total cost of care, The study does not account for cost differences between vertebroplasty and kyphoplasty. Conclusion: Inpatient VA can be cost effective as demonstrated by the same daily cost between the VA and medically managed groups. Early identification and consultation can facilitate VA and rapid discharge. Anticoagulation issues and medical comorbidities can delay VA and lengthen hospital stays. Hospital admitted patients with painful osteoporotic VCF who are managed conservatively and discharged are at risk for readmission. Key words: vertebral augmentation, osteoporotic vertebral compression fracture, vertebroplasty, kyphoplasty