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The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 97 - 102
1 Jan 2022
Hijikata Y Kamitani T Nakahara M Kumamoto S Sakai T Itaya T Yamazaki H Ogawa Y Kusumegi A Inoue T Yoshida T Furue N Fukuhara S Yamamoto Y

Aims

To develop and internally validate a preoperative clinical prediction model for acute adjacent vertebral fracture (AVF) after vertebral augmentation to support preoperative decision-making, named the after vertebral augmentation (AVA) score.

Methods

In this prognostic study, a multicentre, retrospective single-level vertebral augmentation cohort of 377 patients from six Japanese hospitals was used to derive an AVF prediction model. Backward stepwise selection (p < 0.05) was used to select preoperative clinical and imaging predictors for acute AVF after vertebral augmentation for up to one month, from 14 predictors. We assigned a score to each selected variable based on the regression coefficient and developed the AVA scoring system. We evaluated sensitivity and specificity for each cut-off, area under the curve (AUC), and calibration as diagnostic performance. Internal validation was conducted using bootstrapping to correct the optimism.


The Bone & Joint Journal
Vol. 102-B, Issue 7 Supple B | Pages 71 - 77
1 Jul 2020
Gonzalez Della Valle A Shanaghan KA Nguyen J Liu J Memtsoudis S Sharrock NE Salvati EA

Aims

We studied the safety and efficacy of multimodal thromboprophylaxis in patients with a history of venous thromboembolism (VTE) who undergo total hip arthroplasty (THA) within the first 120 postoperative days, and the mortality during the first year. Multimodal prophylaxis includes discontinuation of procoagulant medications, VTE risk stratification, regional anaesthesia, an intravenous bolus of unfractionated heparin prior to femoral preparation, rapid mobilization, the use of pneumatic compression devices, and chemoprophylaxis tailored to the patient’s risk of VTE.

Methods

Between 2004 to 2018, 257 patients with a proven history of VTE underwent 277 primary elective THA procedures by two surgeons at a single institution. The patients had a history of deep vein thrombosis (DVT) (186, 67%), pulmonary embolism (PE) (43, 15.5%), or both (48, 17.5%). Chemoprophylaxis included aspirin (38 patients), anticoagulation (215 patients), or a combination of aspirin and anticoagulation (24 patients). A total of 50 patients (18%) had a vena cava filter in situ at the time of surgery. Patients were followed for 120 days to record complications, and for one year to record mortality.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 125 - 125
1 Jan 2017
Anitha D Subburaj K Kirschke J Baum T
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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]


The Bone & Joint Journal
Vol. 98-B, Issue 9 | Pages 1234 - 1239
1 Sep 2016
Yu HM Malhotra K Butler JS Patel A Sewell MD Li YZ Molloy S

Aims

Patients with multiple myeloma (MM) develop deposits in the spine which may lead to vertebral compression fractures (VCFs). Our aim was to establish which spinopelvic parameters are associated with the greatest disability in patients with spinal myeloma and VCFs.

Patients and Methods

We performed a retrospective cross-sectional review of 148 consecutive patients (87 male, 61 female) with spinal myeloma and analysed correlations between spinopelvic parameters and patient-reported outcome scores. The mean age of the patients was 65.5 years (37 to 91) and the mean number of vertebrae involved was 3.7 (1 to 15).


The Bone & Joint Journal
Vol. 97-B, Issue 10 | Pages 1411 - 1416
1 Oct 2015
Li Y Yang S Chen H Kao Y Tu Y

We evaluated the impact of lumbar instrumented circumferential fusion on the development of adjacent level vertebral compression fractures (VCFs). Instrumented posterior lumbar interbody fusion (PLIF) has become a popular procedure for degenerative lumbar spine disease. The immediate rigidity produced by PLIF may cause more stress and lead to greater risk of adjacent VCFs. However, few studies have investigated the relationship between PLIF and the development of subsequent adjacent level VCFs. . Between January 2005 and December 2009, a total of 1936 patients were enrolled. Of these 224 patients had a new VCF and the incidence was statistically analysed with other covariants. In total 150 (11.1%) of 1348 patients developed new VCFs with PLIF, with 108 (72%) cases at adjacent segment. Of 588 patients, 74 (12.5%) developed new subsequent VCFs with conventional posterolateral fusion (PLF), with 37 (50%) patients at an adjacent level. Short-segment fusion, female and age older than 65 years also increased the development of new adjacent VCFs in patients undergoing PLIF. In the osteoporotic patient, more rigid fusion and a higher stress gradient after PLIF will cause a higher adjacent VCF rate. Cite this article: Bone Joint J 2015;97-B:1411–16


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 52 - 52
1 Jul 2014
Garner P Wilcox R Aaron J
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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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_16 | Pages 43 - 43
1 Apr 2013
Boey J Tow B Yeo W Guo CM Yue WM Chen J Tan SB
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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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 5 - 5
1 Apr 2013
Van Meirhaeghe J Bastian L Boonen S Ranstam J Tillman J Wardlaw D
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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


The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 401 - 406
1 Mar 2013
Rebolledo BJ Gladnick BP Unnanuntana A Nguyen JT Kepler CK Lane JM

This is a prospective randomised study comparing the clinical and radiological outcomes of uni- and bipedicular balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. A total of 44 patients were randomised to undergo either uni- or bipedicular balloon kyphoplasty. Self-reported clinical assessment using the Oswestry Disability Index, the Roland-Morris Disability questionnaire and a visual analogue score for pain was undertaken pre-operatively, and at three and twelve months post-operatively. The vertebral height and kyphotic angle were measured from pre- and post-operative radiographs. Total operating time and the incidence of cement leakage was recorded for each group.

Both uni- and bipedicular kyphoplasty groups showed significant within-group improvements in all clinical outcomes at three months and twelve months after surgery. However, there were no significant differences between the groups in all clinical and radiological outcomes. Operating time was longer in the bipedicular group (p < 0.001). The incidence of cement leakage was not significantly different in the two groups (p = 0.09).

A unipedicular technique yielded similar clinical and radiological outcomes as bipedicular balloon kyphoplasty, while reducing the length of the operation. We therefore encourage the use of a unipedicular approach as the preferred surgical technique for the treatment of osteoporotic vertebral compression fractures.

Cite this article: Bone Joint J 2013;95-B:401–6.


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


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVI | Pages 22 - 22
1 Jun 2012
Quraishi NA Edidin A Kurtz S Ong K Lau E
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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


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 6 | Pages 815 - 820
1 Jun 2012
Nieuwenhuijse MJ van Erkel AR Dijkstra PDS

The optimal timing of percutaneous vertebroplasty as treatment for painful osteoporotic vertebral compression fractures (OVCFs) is still unclear. With the position of vertebroplasty having been challenged by recent placebo-controlled studies, appropriate timing gains importance.

We investigated the relationship between the onset of symptoms – the time from fracture – and the efficacy of vertebroplasty in 115 patients with 216 painful subacute or chronic OVCFs (mean time from fracture 6.0 months (sd 2.9)). These patients were followed prospectively in the first post-operative year to assess the level of back pain and by means of health-related quality of life (HRQoL). We also investigated whether greater time from fracture resulted in a higher risk of complications or worse pre-operative condition, increased vertebral deformity or the development of nonunion of the fracture as demonstrated by the presence of an intravertebral cleft.

It was found that there was an immediate and sustainable improvement in the level of back pain and HRQoL after vertebroplasty, which was independent of the time from fracture. Greater time from fracture was associated with neither worse pre-operative conditions nor increased vertebral deformity, nor with the presence of an intravertebral cleft.

We conclude that vertebroplasty can be safely undertaken at an appropriate moment between two and 12 months following the onset of symptoms of an OVCF.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 187 - 187
1 May 2012
Batty L Dowrick A Lyon S Liew S
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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


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_X | Pages 45 - 45
1 Apr 2012
Wardlaw D Van Meirhaeghe J Bastian L Boonen S
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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


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 19 - 19
1 Mar 2012
Van Meirhaeghe J Wardlaw D Bastian L Cummings S Boonen S
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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)


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 2 | Pages 152 - 157
1 Feb 2012
Longo UG Loppini M Denaro L Maffulli N Denaro V

Osteoporotic vertebral compression fractures (VCFs) are an increasing public health problem. Recently, randomised controlled trials on the use of kyphoplasty and vertebroplasty in the treatment of these fractures have been published, but no definitive conclusions have been reached on the role of these interventions. The major problem encountered when trying to perform a meta-analysis of the available studies for the use of cementoplasty in patients with a VCF is that conservative management has not been standardised. Forms of conservative treatment commonly used in these patients include bed rest, analgesic medication, physiotherapy and bracing. . In this review, we report the best evidence available on the conservative care of patients with osteoporotic VCFs and associated back pain, focusing on the role of the most commonly used spinal orthoses. Although orthoses are used for the management of these patients, to date, there has been only one randomised controlled trial published evaluating their value. Until the best conservative management for patients with VCFs is defined and standardised, no conclusions can be drawn on the superiority or otherwise of cementoplasty techniques over conservative management


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 9 | Pages 1149 - 1153
1 Sep 2011
Muijs SPJ van Erkel AR Dijkstra PDS

Vertebral compression fractures are the most prevalent complication of osteoporosis and percutaneous vertebroplasty (PVP) has emerged as a promising addition to the methods of treating the debilitating pain they may cause.

Since PVP was first reported in the literature in 1987, more than 600 clinical papers have been published on the subject. Most report excellent improvements in pain relief and quality of life. However, these papers have been based mostly on uncontrolled cohort studies with a wide variety of inclusion and exclusion criteria. In 2009, two high-profile randomised controlled trials were published in the New England Journal of Medicine which led care providers throughout the world to question the value of PVP. After more than two decades a number of important questions about the mechanism and the effectiveness of this procedure remain unanswered.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 206 - 206
1 May 2011
Glinkowski W Sitnik R Wojciechowski A Witkowski M Glinkowska B Golebiowski M Gorecki A
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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


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 207 - 207
1 May 2011
Malhotra R Kancherla R Kumar V Jayaswal A
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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


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 142 - 142
1 May 2011
Iundusi R Repmann J Ferraro G Bruchmann B Tempesta V Kilian F Tarantino U
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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