Introduction/Aims. An increased mortality associated with hip fractures has been recognized, but the impact of vertebral osteoporotic compression fractures (VCF) is still underestimated. The aim of this study was to report on the difference in survival for VCF patients following non-operative and operative [Balloon Kyphoplasty (BKP) or Vertebroplasty (VP)] treatments. Methods. Operated and non-operated VCF patients were identified from the US Medicare database in 2006 and 2007 and followed for a minimum of 24 months. Patients diagnosed with pathological and traumatic VCFs in the prior year were excluded. Overall survival was estimated by the Kaplan-Meier method, and the differences in mortality rates (operated vs non-operated; balloon kyphoplasty vs vertebroplasty) were assessed by Cox regression, with adjustments for patient demographics, general and specific co-morbidities, that have been previously identified as possible causes of death associated with osteoporotic VCFs. Results. A total of 81,662 operated (vertebroplasty or kyphoplasty) patients had a survival rate of 74.8% at 24 months following VCF diagnosis compared to 67.4% for the 329,303 non-operated patients. In operated (Vertebroplasty or kyphoplasty) patients there was 44% less mortality than in non-operated VCF patients (p<0.0001). The survival rates for VCF patients following vertebroplasty or kyphoplasty were 72.3% and 76.2% at 24 months, respectively. In kyphoplasty patients there was 12.5% more survival than in vertebroplasty patients (p<0.0001) after 2 years. Conclusions. This retrospective analysis, in 410,965 patients diagnosed with a VCF confirmed the statistical significant decrease (43%, p<0.0001) in mortality between patients receiving minimally invasive surgery compared to non-operated patients. Additionally the present study confirmed a statistical significant decrease (12.5%, p<0.0001) in mortality in BKP patients compared to VP patients

Despite increasing use of vena cava filters (VCFs) for pulmonary embolism (PE) prophylaxis after major trauma, there is continued debate regarding their safety and efficacy. We aimed to evaluate the impact of prophylactic VCFs on the incidence of PE after major trauma and to describe VCF related complications. Prospectively collected data from The Alfred Hospital Trauma Registry were used to identify all major trauma patients admitted between 1 July 2001 and 1 July 2008. Data for each patient was collated from the registry. This included patient demographics, injury specific data, management details (including prophylactic VCF use) and clinical outcomes (including the occurrence of PE). Medical record and radiology chart review was used to verify all PEs. Potential PE risk factors were assessed as covariates in a univariate analysis, with PE as the dependent variable. A multivariate analysis was then performed using multiple logistic regression adjusting for baseline imbalances and known covariates. During this period, 6,344 major trauma patients were treated, with 73.2% male, mean age of 44.2 +/− 21.0 SD, 90.2% with a blunt mechanism of injury and mean ISS of 24.3 +/− 12.0 SD. Of these patients, 511 (8.1%) received prophylactic VCFs, (inserted in absence of PE) at the discretion of the treating clinician. There were 45 PE (incidence of 0.71%), of which two were fatal. Three variables were independently associated with the occurrence of PE in the multivariate analysis: (i) presence of prophylactic VCF (OR 0.28; 95%CI 0.09 - 0.89); (ii) number of injuries to the AIS body region lower limb (OR 1.31; 95%CI 1.17 - 1.47) and (iii) central venous catheterisation (OR 1.87; 95%CI 1.88 - 6.17). Data was available on the VCF database for 429 of the 511 patients with VCFs (84.0%). The mean time to prophylactic VCF insertion was 3.6 +/− 0.2 SEM days after admission. The VCF major complication rate was 2.6% (n=11), including four non-fatal PE. The technical success rate for retrieval was 92.4% (279 retrievals from 302 attempts) and the overall retrieval rate was 65.0% (279 retrievals from 429 placements). Prophylactic VCFs are associated with a reduced rate of PE when used in selected major trauma patients. In addition, prophylactic VCFs have a low major complication rate and high rate of technical success for retrieval

Purpose: The purpose of this biomechanical study was to assess: (1) the effect of thoracic vertebral compression fracture (VCF) on kyphosis and physiologic compressive load path, and (2) the effect of balloon kyphoplasty and spinal extension on restoration of normal geometric and loading alignment. Methods: Six fresh human thoracic specimens, each consisting of three adjacent vertebrae were used. In order to create a VCF, IBTs were placed transpedicularly into the middle VB and cancellous bone was disrupted by inflation of IBTs. After cancellous bone disruption the specimens were compressed using bilateral loading cables until a fracture was observed. Fracture reduction by spinal extension, and then by balloon kyphoplasty was performed under a physiologic compressive preload of 250 N. The vertebral body heights, kyphotic deformity, and location of compressive load path were measured on video-fluoroscopy images. Results: The VCF caused anterior VB height loss of 3715%, middle-height loss of 3416%, segmental kyphosis increase of 147.0 degrees, and vertebral kyphosis increase of 135.5 degrees (p< 0.05). The compressive load path shifted anteriorly by 20% of A-P endplate width in the fractured and adjacent VBs (p=0.01). IBT inflation alone restored anterior VB height to 918.9%, middle-height to 9114%, and segmental kyphosis to within 5.65.9 degrees of pre-fracture values. The compressive load path returned posteriorly in all three VBs (p=0.00): the load path remained anterior to the pre-fracture location by 9–11% of the A-P endplate width. The extension moment fully restored the compressive load path to its pre-fracture location. Under this moment, the anterior and middle VB heights were restored to 858.6% and 749.4% of pre-fracture values, respectively. The segmental kyphosis was fully restored to its pre-fracture value; however, the middle height and kyphotic deformity of the fractured VB remained smaller than the pre-fracture values (p< 0.05). Conclusions: An anterior shift of the compressive load path in VBs adjacent to VCF can induce additional flexion moments. The eccentric loading may contribute to the increased risk of new VB fractures adjacent to an uncorrected VCF deformity. Extension moment could fully correct the segmental kyphosis but could not restore the middle height of the fractured vertebral body. Balloon kyphoplasty reduced the VCF deformity and partially restored the compressive load path to normal alignment

Acute osteoporotic vertebral compression fractures (VCFs) are frequently misdiagnosed as there is often no history of preceding trauma. VCFs not only cause back pain, but can also result in a loss of function, spinal deformity and increased mortality. Cement augmentation has been shown to effectively treat these fractures. It is impossible to diagnose an acute fracture on plain x-ray and therefore identify those likely to benefit from this treatment. The definitive investigation to determine the presence of an acute fracture is a MR scan, but this is a limited resource. The aim of this paper is to evaluate 2 new clinical signs which we believe aid in the diagnosis of an acute VCF: firstly closed fist percussion at the level of an acute VCF resulting in a severe, sharp fracture pain, and secondly the inability of a patient to lie supine. This was a prospective study of 78 patients with suspected acute VCFs. 48/78 had an acute fracture on MR. 42/45 patients who were positive for closed fist percussion, had an acute fracture on their MR scan. There were 6 patients who were negative for closed fist percussion who had an acute fracture (sensitivity 87.5%, specificity 90%). 39/41 patients who were positive for the supine sign had an acute fracture on their MR scan. There were 9 patients who were comfortably able to lay supine who had an acute fracture (sensitivity 81.25%, specificity 93.33%). Either a positive closed fist percussion sign or a positive supine sign is a reliable indicator of the presence of an acute VCF. By incorporating these signs into our routine clinical assessment we are better able to predict which patients have an acute fracture, and therefore decide which patients need a MR scan

Introduction: It is commonly admitted that for any joint fracture in the human body, a perfect anatomical reduction before stabilization is the only manner to biomechanically restore a joint and avoid late complications by early mobilization allowance. But, there is no evidence of anatomical fracture reduction when using vertebroplasty or balloon kyphoplasty in case of traumatic vertebral compression fractures (VCF). Materials & Methods: A new procedure was proposed using titanium permanent vertebral cranio-caudal expandable implants (VCCEI) in combination with PMMA cementoplasty. The procedure has consisted in two steps: first, reduce the fractured vertebral body under fluoroscopic guidance by expanding the implants and second, stabilize the vertebra in its reduced position using PMMA cement injection. The implants ability to reduce the fractured endplates was assessed within a prospective international clinical study enrolling 37 patients (Mean age: 53yo, 18F/19M). 40 VCF (34 single level and 3 double levels) were included in this series. Mean fracture age was 11 days at the time of surgery. To evaluate the anatomical restoration, a new 3D measurement method was developed using millimetric CT scans 3D reconstructions. Morphologic parameters such as vertebral kyphosis angle and endplate surface restoration were calculated and clinical parameters were monitored (VAS score monitoring, hospital stay duration). Results: First results are showing that the VCCEI is able to reduce the fractured vertebra whatever is the type of fracture providing that it is still mobile. Both vertebral kyphosis angle reduction and endplate surface restoration were achieved: up to 92% improvement for vertebral kyphosis and up to 10,8mm height increase in the anterior part of a fractured endplate. Posterior wall displacements were negligible. Neither antepulsion nor retropulsion of broken fragments were observed. No postoperative complication was reported but minor asymptomatic cement leakages. Pain was significantly reduced at the same time and hospital stay was comparable to. Conclusion: This new procedure has demonstrated its clinical and radiological efficacy in achieving anatomical reduction of VCF as well as relieving pain. The unique design of this VCCEI allows the surgeon to apply controlled cranio-caudal forces to reduce the fractured vertebra according to the fracture type and thus optimize the way the fracture will be reduced. Providing that the technique allows for a good control of the way the reduction is performed, there is a new possibility to treat VCF as they should deserve

Background. Balloon kyphoplasty (BKP) is a minimally invasive cementing procedure, occasionally used in patients with painful vertebral compression fractures (VCF). In this multicenter Swedish RCT, we evaluated the cost-effectiveness of BKP compared with standard medical treatment, Control, in osteoporotic patients with acute/sub-acute VCF (<3 months). In a multicenter European clinical study (FREE trial) including 300 patients and FU after one year, BKP was suggested to be a safe and effective procedure in selected patients. The current study includes the Swedish patients in the FREE trial Method: Hospitalized patients with a back pain level of at least 4/10 on a visual analogue scale due to of VCF between Th5–L5 (confirmed by MRI) were randomized to either BKP or Control treatment (standard medical treatment with pain medication and functional support). All VCF-associated costs (hospital, primary care, rehabilitation, community care, private care, pharmaceuticals, assistance by relatives, work absenteeism) were identified and reported from the perspectives of cost to society, and costs to the healthcare system. Primary outcome was quality of life change (QoL) measured with the preference based EQ-5D instrument. The accumulated quality adjusted life years gained (QALYs) and costs per QALY gained was assessed. Willingness to pay (WTP) for a QALY gained in Sweden was estimated at approximately SEK 600,000 (EURO 62,500). Sensitivity analyses were performed. Results. Between February 2003 and December 2005, 70 patients were randomized to BKP (n=35) or to standard medical treatment (n=35). Three patients in the Control group declined to participate in an economic evaluation, and only patients answering EQ-5D at all FU occasions (1-3-6-12-24 months) were included in the analyses, leaving in all 63 patients, BKP=32, Control=31. Baseline data were similar. The mean age in the BKP group was 72 years (71% women) vs. 75 years (78% women) in the Control group. Baseline difference in QoL was adjusted for using statistical methods. There were no cross overs. Four patients in the BKP group and three patients in the Control group died within two years of causes not related to the VCF. Costs were collected using “cost diaries” in mailed questionnaires after 1-3-6-12-18-24 months. Costs and EQ-5D values (0 at FU after death) were carried forward. Total mean societal cost per patient for BKP and Control was SEK 160,017 (SD 151,083) and SEK 84,816 (SD 40,954), respectively. The difference was significant 75,198 (95% CI 16,037 to 120,104). The accumulated mean difference in QALYs was 0.085 (−0.132 to 0.306) units in favour of BKP. Cost per QALY gained using BKP was SEK 884,682 (EURO 92,154) with high uncertainty assessed using the bootstrapping technique, and demonstrated on the cost-effectiveness plane and on the acceptability curve. When the EQ-5D values from all patients in the FREE trials were included in a sensitivity analysis, cost/QALY was SEK 359,146 (EURO 37,411) Conclusion: Costs were significantly higher for BKP compared with standard medical treatment, with no significant difference in QALYs gained. In this selected patient population with vertebral compression fracture due to osteoporosis, BKP could not be concluded as cost-effective after two years

Introduction: Spine fractures are common manifestation of osteoporosis. After an acute osteoporotic vertebral compression fracture pain persisting even after 3 months and clinical tenderness should raise the suspicion of pseudarthrosis. Pseudarthrosis is not a rare complication of a benign osteoporotic vertebral collapse occurs in about 10% of cases after an acute collapse. Treatment plan needs to be individualized. Cement augmentation procedures such as kyphoplasty and vertebroplasty can be performed in the absence of neurological deficit, whereas decompression and stabilization is necessary in presence of neurological deficit. Study Design: Prospective cohort study. Methods: 31 patients who were diagnosed to have an acute osteoporotic vertebral compression fracture were managed conservatively. Pain persisting after 3 months and clinical tenderness in 5 patients prompted further investigation, revealing pseudarthrosis. None of them had neurological deficit. Imaging of two patients revealed vacuum sign with intravertebral cleft on plain radiographs and on MRI. All of them were at the Dor-solumbar junction and of crush typeof VCF. Results: The incidence of pseudoarthrosis after an oste-porotic VCF was found to be 16.12%. One patient was treated with kyphoplasty, one with vertebroplasty with good pain relief and restoration of functional ability, and rest three are awaiting kyphoplasty. Conclusion: High suspicion of pseudarthrosis is to be kept in mind as it is not an uncommon complication of benign osteoporotic collapse. Vertebral augmentation procedures such as kyphoplasty and vertebroplasty are promising procedures for treatment in absence of neurological deficit

Balloon kyphoplasty (BKP) is a minimally invasive treatment for vertebral fractures (VCF) aiming to correct deformity using balloon tamps and bone cement to stabilize the body. Patients with 1 - 3 non-traumatic acute VCF were enrolled within three months of diagnosis and randomly assigned to receive either BKP (N=149) or nonsurgical care (N=151). Follow-up was 2 years. The mean SF-36 physical component summary (PCS) score improved 5.1 points (95%CI, 2.8-7.4; p<0.0001) more in the kyphoplasty than the nonsurgical group at one month, the primary endpoint of the study. Kyphoplasty improved the PCS score by an average of 3.0 points (95%CI, 1.6-5.4; p=0.002) during the two-year follow-up. There was a significant interaction between treatment and follow-up time (p=0.003), indicating that the treatment effect over the year is not uniform across follow-up; a result from early improvement that persists in the kyphoplasty group whereas the nonsurgical group shows more incremental improvement over time. Overall, patients assigned to kyphoplasty also had statistically significant improvements over the two years compared to the control group in global quality of life (EQ-5D), pain relief (VAS), back disability (RMDQ) and days of limited activity (within a two-week period). There was no statistical significant difference between groups in the number of patients with adverse events or new VCF's over 24 months. Compared to the control, BKP improved quality of life and reduced back pain and disability and did not increase adverse events including the risk of new vertebral fractures over 2 years

Background: Despite of advanced implant modifications and surgical techniques, internal fixation of proximal femur fractures in osteoporotic elderly is conditioned by high rate of complicated healing and implant failure. The deterioration in micro architecture and the loss in mechanical properties of trabecular bone due to impaired bone turnover must be treated. Teriparatide(TPTD) has been demonstrated to improve of new bone formation in both trabecular and cortical envelopes and thus bone strength. Moreover in a number of fracture models on anims stimulates the healing process generating larger total callus volume. The aim of this study was to determine if bone anabolic agent (TPTD) may enhance the repair of femoral neck fractures in osteoporotic elderly synthesized with internal fixation and prevent complications. Study Design: 31 compliant females between 57 and 95 years-old presenting a lateral femoral neck fracture was considered. At admission in orthopaedic unit they were undergone to haematochemical exams extended to bone turnover markers, lumbar and contralateral femoral BMD measured by DXA and x-rays of dorsal-lumbar spine. They were divided in two subgroups on the basis of concomitant vertebral compression fracture (VCF) discovered. To the patients with VCF was administrated daily subcutaneous injection of 20 microgr. of TPTD (TPTD group). Both groups received 1g of calcium carbonate and 1200 IU of colecalciferol daily from the first post-operative week. All the patients repeated x-rays of affected segments and bone turnover markers at 1,3,6 months. The pain was detected through a self-reported visual analogue scale (VAS). The functional outcome was evaluated in term of hospitalization, of walking on two crutches and their abandon. Results: At admission serum 25(OH) vitamin D concentration was at lower levels but the supplementation was sufficient to normalize even if in TPTD group it remained lower than control. In TPTD group the bone formation markers were significantly increased at 1st month and peaked at 3rd month without an increase in bone resorption markers. In TPTD group the callus formation was radiologically evident from 1st month followed by consolidation within 3rd month for all. While in control group the fracture repair was less detectable at 3rd month with heterogeneous trend: one needed a re-operation, four were afflicted by delayed union and another one by VCF. Moreover earlier walking and abandon of crutches in TPTD group was related to significant decrease of pain. At 6th month BMD is significantly increased only in TPTD group. Conclusions: In osteoporotic femoral neck fractures the demonstration of enhanced repair, the stability of the osteosynthesis, the pain relief and the recovery of autonomy in walking obtained with adjuvant anabolic therapy (TPTD) opens new therapeutic perspectives

Multiple myeloma (MM) is a chronic, malignant B-cell disorder, with a less than 50% 5-year survival rate [1]. This disease is responsible for vertebral compression fractures (VCFs) in 34 to 64% of diagnosed patients [1], and at least 80% of MM patients experience pathological fractures [3]. Even though reduced DXA-derived bone mineral density (BMD) has been observed in MM patients with vertebral fractures [4], the current quantitative standard method is insufficient in MM due to the osteo-destructive bone changes. Finite-element (FE) analysis is a computational and non-destructive modeling and testing approach to determine bone strength using 3D bone models from CT images. Thus, this study aimed to assess the differences in FE-predicted critical fracture load in MM patients with and without VCFs in the thoracic and lumbar segments of the spine. Multi-detector CT (MDCT) images of two radiologically assessed MM patients (1 with VCFs and 1 without VCFs) were used to generate three-dimensional (3D) models of the whole spine. For each subject, the thoracic segments, 1 to 12 (T1-T12) and lumbar segments, 1 to 5 (L1-L5) were segmented and meshed. Heterogeneous, non-linear anisotropic material properties were applied by discretizing each vertebral segment into 10 distinct sets of materials. A compressive load was simulated by constraining the surface nodes on the inferior endplate in all directions, and a displacement load was applied on the surface nods on the superior endplate [2]. This analysis was performed using ABAQUS version 6.10 (Hibbitt, Karlsson, and Sorensen, Inc., Pawtucket, RI, USA). The MM subject with VCFs had originally experienced fractures in the T4, T5, T12, L1, and L5 segments whereas the MM subject without VCFs experienced none. The former displayed large and abrupt differences in fracture loads between adjacent vertebrae segments, unlike the latter, which exhibited progressive differences instead (no abrupt changes between adjacent vertebrae segments observed). Results from this preliminary study suggest that segments at high risk of fracture are collectively involved in an unstable network, which place the vertebral segments with high values of fracture loads (peaks) as well as the adjacent segments at risk of VCF. For instance, the high fracture load at T11 places T10, T11 and T12 at risk of fracture. Accordingly, T12 has already fractured, and T10 and T11 remain at risk. The relative changes between adjacent vertebrae segments that indicate instability (extremely high fracture load values) enables ease of identification of segments at high fracture risk. Clinicians would be able to work with pre-emptive treatment strategies in future as they can focus on more targeted therapy options at the high-risk vertebrae segments [3]

Introduction. The risk factors for new adjacent vertebral compression fracture (NAVCF) after Vertebroplasty (VP) or Kyphoplasty (KP) for osteoporotic vertebral compression fractures (VCFs) were investigated. Materials and methods. The authors retrospectively analyzed the incidence of NAVCFs in 135 patients treated with VP or KP for osteoporotic VCFs. Study period was from 2004 to 2008 with minimum follow-up of 2 years. Possible risk factors were documented: age, gender, body mass index, bone mineral density (BMD), co-morbidities, location of treated vertebra, treatment modality and amount of bone cement injected. Anterior-posterior vertebral body height ratio, intra-discal cement leakage into the disc space and pattern of cement distribution of the initial VCF and adjacent vertebral bodies were assessed on lateral thoracolumbar radiographs by 2 independent assessors. Results. 21 patients (15.6%) had subsequent symptomatic NAVCFs with a median time to new fracture was of 125 days. There was no difference in incidence of NAVCF between VP and KP groups (P>0.05). Significant differences were found between patients with and without NAVCF in terms of age, BMD, and the proportion of cement leakage into the disc space (P < 0.05). Greater age, intra-discal cement leakage and low BMD were found in patients with NAVCF. Conclusion. The most important risk factors affecting NAVCFs were age, osteoporosis and intra-discal cement leakage

Purpose. To compare the efficacy and safety of balloon kyphoplasty (BKP) to non-surgical management (NSM) over 24 months in patients with acute painful fractures by clinical outcomes and vertebral body kyphosis correction and surgical parameters. Material and Methods. Three hundred Adult patients with one to three VCF's were randomised within 3 months of the acute fracture; 149 to Balloon Kyphoplasty and 151 to Non-surgical management. Subjective QOL assessments and objective functional (Timed up and go [TUG]) and vertebral body kyphotic angulation (KA), were assessed over 24 months; we also report surgical parameters and adverse events temporally related to surgery (within 30-days). Results. Kyphoplasty was associated with greater improvements in SF-36 PCS scores when averaged across the 24-month follow-up period, compared with NSM (overall treatment effect 3.24points, 95% CI, 1.47–5.01; p=0.0004)., and TUG (overall treatment effect −3.00 seconds, 95% CI, −1.0 to −5.1; p<0.0043). At 24 months, the change from baseline in KA was statistically significantly improved in the kyphoplasty group (average 3.1°of correction for BKP versus 0.8°for NSM, p=0.003). On average IBT inflation volumes were consistent with cement volumes at 2.4 cc per side. The most common adverse events within 30-days were back pain, new vertebral fracture, nausea/vomiting and UTI. BKP is calculated to be cost-effective in the UK setting. Conclusions. Compared with NSM, BKP improves patient function and QOL when averaged over 24-months and results in better improvement of index vertebral body kyphotic angulation. Author potential conflicts of interest; JVM, LB; SB, DW and JR are consultants for Medtronic Spine LLC for the FREE study; JBT is currently employed by Medtronic, Inc

Aim: To show the place of percutaneous vertebroplasty (PV) in the treatment of painful osteoporotic vertebral compression fractures (VCF). VCF is a common and often debilitating complication of osteoporosis. Although most fractures heal within a few weeks or months, a minority of patients continues to suffer with pain that does not respond to conservative therapy. Methods: PV is accomplished by percutaneous injection of cement into the fractured vertebral body. Reinforcing and stabilizing the fracture provides pain relief. Injection of cement is accomplished under real time using a bilateral transpedicular approach or a unilateral transpedicular or parapedicular route. Results: PV is indicated in patients with severe, persistent and often incapacitating focal back pain not responding to a standard medical therapy of 4 to 12 weeks duration and related to one or more collapsed vertebral bodies. PV should be used earlier in patients at risk of immobilization complications and requiring narcotics. The success rate exceeds 90% and the complication rate is lower than 1%. Most of the complications are transient and should be avoided using good technique. Conclusion: PV should be always considered as a good alternative treatment compared to medical therapy in painful patients with osteoporotic compression fractures

Background. Vertebral body compression fractures (VCFs) impair quality of life (QOL) and increase patient morbidity and mortality. The international, multicentre, randomised, controlled Fracture Reduction Evaluation (FREE) trial was initiated to compare effectiveness and safety of Balloon kyphoplasty (BKP) to non-surgical management (NSM) for the treatment of acute painful VCFs. We describe the primary endpoint of the ongoing 2-year study. Methods. Patients with 1-3 non-traumatic VCFs (< 3 months old) were randomised to either BKP or NSM. The primary endpoint was the change in QOL as measured by the SF-36 Health Survey Physical Component Summary (PCS) at one month, and device/procedure-related safety. Secondary endpoints included SF-36 subscales, the EQ-5D, self-reported back pain and function using the Roland Morris Disability Questionnaire (RMDQ). All patients were given osteoporosis medical therapy. Results. Among the BKP (N=149) and NSM (N=151) cohorts, mean patient age was 73 years and 77% were female. Most patients had VCFs due to primary osteoporosis; 8 patients due to corticosteroid-induced osteoporosis, and 4 had cancer-related fractures. Thirty-nine BKP (26%) and 36 NSM (24%) patients had >1 VCF treated. At one month follow-up, the mean improvement in the PCS was in favour of BKP over NSM (p<0.0001). All physical component SF-36 subscales and the total EQ-5D score were significantly improved for BKP compared to NSM. Mean improvements in back pain at 7 days and 1 month were significantly greater for BKP compared to NSM (p<0.0001 at both time points). The improvement in RMDQ for BKP over NSM was also significant (p<0.0001). There was one soft tissue haematoma and urinary tract infection, with no bone cement-related serious adverse events. Conclusions. Compared to non-surgical management, balloon kyphoplasty demonstrated superior short-term pain, function and quality of life outcomes with no difference in serious adverse events for the treatment of acute, painful vertebral compression fractures. (Clinical trials.gov number, NCT00211211)

Purpose: Balloon kyphoplasty (BKP) is a minimally invasive treatment for acute vertebral compression fractures (VCF) that aims both to correct associated vertebral deformity (reduce) and stabilize the fracture by injecting bone cement. We performed the first multicenter randomized trial to assess the effect of BKP. Method: Patients with 1–3 non-traumatic vertebral compression fractures diagnosed within 3 months were randomly assigned to receive either BKP (N=149) or usual nonsurgical care (NSC) (N=151). Measurements of quality of life, back pain and function, days of disability and bed rest were assessed at baseline, 1, 3, 6 and 12 months. Results: The primary outcome measure, the difference between groups in change from baseline scores in the physical component summary of the SF-36 questionnaire, improved 3.5 points (95% CI, 1.6 to 5.4; p=0.0004) more in the BKP group when averaged across 12 months of follow-up. Compared with the NSC group, those assigned to BKP also had greater improvement in quality of life and back function throughout 12 months of follow-up as measured by the EuroQol and Roland-Morris scales; a difference of 0.14 points (95% CI, 0.05 to 0.23; p=0.0023) more and 3.2 points (95% CI, 1.7 to 3.8; p< 0.0001) and reported fewer days of limited activity in the previous 2 weeks due to back pain (2.5 fewer days; 95% CI, 1.2 to 3.8; p=0.0001). New radiographically detected vertebral fractures occurred in 41.8% of subjects in the kyphoplasty and 37.8% in the nonsurgical group (4% difference; 95% CI −7.5 to 15.6; p=0.5). Conclusion: Compared to nonsurgical treatment, balloon kyphoplasty improved multiple measurements of quality of life, back pain and disability that last at least one year after the procedure. No difference is seen between groups in radiographically detected VCF’s (Clinicaltrials.gov number, NCT00211211)

Summary Statement. Prophylactic vertebroplasty treatment of ‘at-risk’ vertebrae may reduce fracture risk, however which areas weaken, thus providing surgical targets? Direct spatial 3D mapping of ReTm overcomes the constraints of 2D histology, and by application may provide insight into specific regional atrophy. Introduction. Insidious bone loss with age makes the skeleton fracture-prone in the rapidly expanding elderly population. Diagnosis of osteoporosis is often made after irreversible damage has occurred. There are over 300,000 new fragility fractures annually in the UK, more than 120,000 of these being vertebral compression fractures (VCF). Some VCFs cause life-altering pain, requiring surgical intervention. Vertebroplasty is a minimally invasive procedure whereby bone cement is injected into the damaged vertebral body with the aim of stabilisation and pain alleviation. However, vertebroplasty can alter the biomechanics of the spine, apparently leaving adjacent vertebrae with an increased VCF risk. Prophylactic augmentation of intact, though ‘at-risk’, vertebrae may reduce the risk of adverse effects. The question therefore arises as to which areas of a non-fractured vertebral body, structurally weakened with age, and thus should be targeted. Frequent reports of an overlap in BMD (bone mineral density) between fracture and non-fracture subjects suggest the combination of bone quantity and its ‘quality’ (microarchitectural strength) may be a more reliable fracture predictor than BMD alone. Providing a reliable method of cancellous connectivity measurement (a highly significant bone strength factor) is challenging. Traditional histological methods for microarchitectural interconnection are limited as they usually indirectly extrapolate 3D structure from thin (8 µm) 2D undecalcified sections. To address this difficulty, Aaron et al (2000) developed a novel, thick (300 µm) slicing and superficial staining procedure, whereby unstained real (not stained planar artifactual) trabecular termini (ReTm) are identified directly within their 3D context. The aim of this study was to automate a method of identifying trabecular regions of weakness in vertebral bodies from ageing spines. Patients and methods. 27 Embalmed cadaveric vertebral bodies (T10-L3) from 5 women (93.2±8.6 years) and 3 men (90±4.4 years) were scanned by µCT (micro-computerised tomography; µCT80, Scanco Medical, Switzerland, 74 µm voxel size), before plastic-embedding, slicing (300µm thick), and surface-staining with the von Kossa (2% silver nitrate) stain. The ReTm were mapped using light microscopy, recording their coordinates using the integrated stage, mapping them within nine defined sectors to demonstrate any apparent loci of structural disconnectivity that may cause weakness disproportionate to the bone loss. A transparent 3D envelope corresponding to the cortex, was constructed using code developed in-house (Matlab 7.3, Mathworks, USA), and was modulated and validated by overlay of the previous µCT scan and the coordinate data. Results. The ReTm distribution was found to be remarkably heterogeneous (p<0.05) and independent of the bone volume (p<0.05). For example, there was preliminary evidence of central endplate disconnection predominantly in the selected preparations. Discussion/Conclusion. Such automated spatial mapping of the ReTm within a 3D framework overcomes the constraints of 2D histology. By application of this new automated method, patterns of trabecular disconnection in the spine may now provide insight into specific regional atrophy, perhaps explaining why some vertebrae fracture while others with the same BMD do not, and indicating better targets for prophylactic vertebroplasty

Introduction: The study is aimed to present patient oriented diagnostics, treatment, remote rehabilitation potential and preliminary outcomes assessment in the group of osteoporotic compression fracture cases. Methods: 3D postural assessment originally developed of spinal curvatures, semi quantitative radiographic evaluation and QCT BMD measurement were used in the study. The kyphosis angle based on back shape curve was measured on the 3D surface image utilizing dedicated software mimicking Debrunner kyphometer measurement. Radiographic assessment and measurements were performed on digital images using DICOM viewing analytic software (DICOM Vision, Alteris Ltd.). Radiographic assessment of VCF was based on semiquantitative visual and quantitative morphometric assessment. Bone mineral density were measured utilizing DXA BMD (g/cm2) and QCT BMD (mg/cm3) of the lumbar spine. The polish translation of Oswestry Disability Index (ODI) version 2.1a (. http://www.orthosurg.org.uk/odi/index.htm. ). Telerehabilitation service was served as a supplementary service utilizing Internet videoconferencing. Summary and nonparametric statistical analysis was performed. Results: The group of elderly patients finally enrolled to the study consisted of patients whose data, images, and other examinations were analyzed. Average age of patients was 73,22 years. Average number of fractured vertebra was 3,6 in the study group. The most frequent anatomical location of fractures was lumbar first and third vertebral body. The most frequent fracture types according to Genant et al. classification were Biconcave Grade II (38,6%) and Wedge Grade II (36,9%). The most frequent 53-A1.2 and 53-A2.1 types of fractures. An average QCT bone density was lower than 80 mg/cm3 in whole examined group that represents severe osteoporosis. Bone density lower than 30 mg/cm3 was found in almost one third of the group that coincided with highest number of fractured vertebral bodies. Oswestry disability score was highest along with lowest values of QCT BMD, and significantly improved after vertebral augmentation. Telerehabilitation was considered as successful among computer skilled patients. Discussion: and Conclusion: Described personalized approach shows the flow of the individual patient from Metabolic Bone Diseases and Osteoporosis Unit through diagnostics and surgery to telerehabilitation service opportunities. The 3D structural light method of posture was developed and implemented. Telerehabilitation service may activate patients at home. Complex personalized, team approach to osteoporotic vertebral fractures consisted of new diagnostics, vertebral augmentation and remote rehabilitation

Introduction: Vertebral compression fractures (VCFs) are the most common complications in patients with poor bone quality: trabecular bone discontinuity, occurring with aging, leads to trabecular loosening, subsequent microcracks and vertebral collaps. Percutaneous vertebral augmentations as vertebroplasty and kyphoplasty are minimally invasive surgical procedures developed for the management of symptomatic VCFs not responding to medical treatment, but related complications are not uncommon. The aim of this international multicentric study was to assess the reduction of pain, complications and results of Vesselplasty, a new kyphoplasty procedure. Material and Methods: From January 2006 to July 2008 we treated 327 VCFs in 264 patients, 193 women and 71 men (mean age 68 years). Procedures were managed by one or two C-arm fluoroscopic techniques. The highest level was D6 while more common were at the thoracolumbar junction. Patients were followed at 1, 6, 12 and 24 months using plain X-rays or reformatted CT images. Pain was evaluated with visual analog scale (VAS) and SF-36 assessed at baseline, after the procedure, and after 1, 6, 12 and 24 months. Data analysis was used Student-t test. All patients received antiosteoporosis medical treatment, pain medication, and physiotherapy. Results: We always performed transpedicular minimally invasive approches using Vessel-X. ®. with low-viscosity bone cement mixed with calcium sulphate. The average amount of cement injected, for each vertebral body, was 5cc (range 3.5–7cc). The mean preoperative scores of 8.3 (VAS), 12.6 (SF-36 Bodily Pain) and 10.9 (SF-36 Physical Function) were improved to 2.3, 54.9 and 52.2, respectively (P< 0.001) at 1 month follow-up and 2.1, 65.7 and 59.4, respectively (P< 0.001) at 12 month follow-up. No case reported pedicular or intracanal leaks of cement. Intradiscal leakages occurred in 20 levels (6.1% of total) but asymptomatic. Another VCF, within the first year after operation, took place in 29 patients, but only in 9 cases (3.4% of total) was an adjacent level. Conclusion and Discussion: Treatment of osteoporosis has made enormous advances in the past years, resulting in a wide range of options. Vesselplasty is a safe and effective minimally invasive procedure for pain relief associated with VCFs, and improves mobility and quality of life in these patients. Vesselplasty permits the interdigitation of bone filler materials into the surrounding trabecular bone: the double layers containers reduce the risk of leaks of cement and restore the vertebral height. We underline the importance of a global approach to the osteoporotic patients: the best treatment remains early diagnosis evaluating bone remodelling markers, lumbar and femoral DXA, thoraco-lumbar X-rays and risk fracture assessment to guarantee the most appropriated therapy as specific as possible

Introduction: Traumatic vertebral compression fractures (VCF) should be distinguished from fragility fractures, occurring as a result of decreased bone strength due to osteoporosis or cancer. Polymethylmethacrylate cement (PMMA), as standard in fragility fractures, does not have the capacity to undergo remodeling. Therefore in young patients, a bio-compatible/–resorbable alternative would be preferable. KyphOs FS(R), a calcium magnesium hydroxyapatite cement has been developed for use during Balloon Kyphoplasty (BKP), a minimal invasive therapy. This single-arm multicenter study evaluates the safety and effectiveness of this cement during BKP in young patients with stable VCFs. We describe the clinical results up to 3mo of the ongoing 1-year follow-up study. Methods: Male and female patients, aged 50 years or less, with up to 3 VCFs of type A1.1, A1.2 or A3.1, according to the Magerl/AO classification were included. The primary endpoint was the change from baseline in the 24 point Roland Morris Disability Questionnaire (RMDQ) score at seven days. Secondary endpoints included the quality of life as measured by EuroQol-5 Domain questionnaire (EQ-5D), the 10 point self-rated back pain (VAS) and device and/or procedure related adverse events. Based on the standard deviation in the Wood study, up to 100 patients had to be enrolled to detect the minimal clinical important difference (MCID) of 2–3 pts on the primary endpoint. Results: 50 patients out of 51 enrolled were eligible. The mean age was 36.4 years, 64% were male. 80% of the patients were treated for 1 VCF, 14% for 2 VCFs and 6% for 3 VCFs. At 3 mo, data of 45 patients were available. Mean RMDQ score at baseline was 20.29pts. The change from baseline in RMDQ at 7d was 9.42pts(95%CI 7.50–11.34, p< 0.0001) and 16.76pts(95%CI 15.21–18.30,p< 0.0001) at 3mo. Mean EQ-5D score at baseline was 0.16pts. The change from baseline in total EQ-5D at 7d was 0.52pts(95%CI 0.42–0.62,p< 0.0001) and 0.71pts(95%CI: 0.60–0.82,p< 0.0001) at 3mo. The change from baseline in VAS at 7d was 4.44pts(95%CI 3.80–5.08,p< 0.0001) and 5.43pts(95%CI 4.81–6.05,p< 0.0001) at 3mo. There were no device-related serious adverse events during the peri-operative period up to 3 mo. Discussion: The MCID on the RMDQ is 2–3pts. In this study we obtained a difference of 9.42 points at 7 days. The recruitment was terminated earlier because of the highly significant results. The results on RMDQ were confirmed on all the other secondary endpoints with further improvement up to 3 mo. Conclusion: The use of KyphOs FS(R) during BKP, appears to be a safe and effective method to treat traumatic VCFs in young patients. Longer follow-up is needed to confirm the results at 1 year