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.

The spine is a common site of metastasis. Complications include pathologic fracture, spinal cord compression, and neurological deficits. Vertebroplasty (VP) and Balloon Kyphoplasty (KP) are minimally invasive stabilization procedures used as a palliative treatment to improve mechanical stability, quality of life, and reduce pain. Photodynamic therapy (PDT) is a tumour-ablative modality that may complement mechanical stability afforded by VP/KP. This first-in-human study evaluates PDT safety when applied in conjunction with VP/KP. This dose escalation trial involved one light only control group and four light-drug doses (50,100,150,200J;n=6) delivered at 150mW from a 690nm diode laser by 800-micron optical fibers prior to KP/VP. Patients eligible for VP/KP in treating pathologic fracture or at-risk lesions at a single level were recruited. Exclusion criteria included spinal canal compromise or neurologic impairment. PDT is a two-step binary therapy of systemic drug followed by intravertebral light activation. Light was applied via bone trochar prior to cementation. This study used a benzoporphyrin derivative monoacid (BPD-MA), Verteporfin (VisudyneTm), as the photosensitizer drug in the therapy. Drug/light safety, neurologic safety, generic (SF-36), and disease-specific outcomes (VAS, EORTC-QLQ-BM22, EORTC-QLQ-C15-PAL) were recorded through six weeks. Phototoxicity and the side effects of the BPD-MA were also examined following PDT use. Thirty (10 male, 20 female) patients were treated (13 KP, 17 VP). The average age was 61 and significantly different between genders (Male 70yrs vs. Female 57yrs: p 0.05), and tumour status (lytic vs. mixed blastic/lytic: p>0.05). In most cases, fluence rates were similar throughout PDT treatment time, indicating a relatively stable treatment. Twelve (40%) of patients experienced complications during the study, none of which were attributed to PDT therapy. This included two kyphoplasty failures due to progression of disease, one case of shingles, one ankle fracture, one prominent suture, one case of constipation due to a lung lesion, one case of fatigue, and five patients experienced pain that was surgically related or preceded therapy. Vertebral PDT appears safe from pharmaceutical and neurologic perspectives. KP/VP failure rate is broadly in line with reported values and PDT did not compromise efficacy. The 50J group demonstrated an improved response. Ongoing study determining safe dose range and subsequent efficacy studies are necessary

Balloon kyphoplasty (BKP) is a minimally invasive surgical technique used to correct kyphosis and vertebral compression fractures. BKP uses cement to fill a void created by the inflation of a balloon in a vertebra, it can be used as an alternative to vertebroplasty to reduce cement extravasation. Issues such as poor inter digitisation of the cement and the trabecular bone can arise with the BKP method. This can be due to a compacted layer created during the procedure which can cause complications post-surgery. The primary aim of this study was to investigate alternative cement application methods which could improve the mechanical strength of the bone-cement interface. Three alternative methods were investigated, and cylindrical bone-cement specimens were created for all methods (BKP and three alternatives). An important part of this study was to replicate the compacted layer created by the inflation of the balloon tamp in BKP. Synthetic trabecular bone specimens (Sawbones®, Pacific Research Laboratories, Vashon Island, Washington, USA) were pre-loaded in compression and the resultant compacted layers were found to replicate the compacted layers found in surgery. Mechanical testing was carried out with an MTS Model 858 Bionix. ®. Servohydraulic load frame using static tensile and torsion loads. Static tests revealed that two of the three alternative methods were an improvement on BKP, with a high statistical significance in relation to the mechanical performance of the bone-cement interface (P < 0.001). This data illustrates the potential to improve the standard BKP technique, in terms of bone-cement interface performance

This study assesses whether balloon kyphoplasty (BKP) can safely restore height and correct deformity for cancer-related vertebral compression fractures (VCFs) involving the posterior vertebral body wall (PVBW), which is normally considered a relative contraindication. Retrospective cohort study of 158 patients (99M:59F; mean age 63 years) with 228 cancer-related VCFs, who underwent BKP. 112 had VCFs with PVBW defects, and 46 had VCFs with no PVBW defect. Data was assessed preoperatively and at 3 months. In the PVBW defect group, mean pain score decreased from 7.5 to 3.6 (p<0.001). There was a significant decrease in kyphotic angle (p<0.01), anterior vertebral body height (AVBH) (p<0.01) and mid-vertebral body height (MVBH) (p<0.05). In the PVBW intact group, mean pain score decreased from 7.3 to 3.3 (p<0.001). There was a significant improvement in AVBH and MVBH (p<0.001). When comparing groups, kyphotic angle, AVBH and MVBH were significantly worse in the PVBW defect group (P<0.05). More cement leaks occurred in the PVBW defect group. BKP can alleviate pain but does not restore height or correct kyphosis in patients with cancer-related VCFs and PVBW defects. There is no appreciable increase in surgical risk

We reviewed 59 bone graft substitutes marketed by 17 companies currently available for implantation in the United Kingdom, with the aim of assessing the peer-reviewed literature to facilitate informed decision-making regarding their use in clinical practice. After critical analysis of the literature, only 22 products (37%) had any clinical data. Norian SRS (Synthes), Vitoss (Orthovita), Cortoss (Orthovita) and Alpha-BSM (Etex) had Level I evidence. We question the need for so many different products, especially with limited published clinical evidence for their efficacy, and conclude that there is a considerable need for further prospective randomised trials to facilitate informed decision-making with regard to the use of current and future bone graft substitutes in clinical practice.

Cite this article: Bone Joint J 2013;95-B:583–97.

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

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. As life expectancy in the population rises, osteoporotic fractures are seen most frequently in the vertebral column. Percutaneous kyphoplasty is increasingly used for pain reduction and stabilization in these patients, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. OBJECTIVE. To clarify whether kyphoplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. MATERIALS & METHODS. From January 2004 to June 2009, 122 patients (31 males and 91 females), from 56 to 85 years old (mean age 68.5) were treated for 165 osteoporotic vertebral fractures of the thoracic or lumbar spine (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Twelve patients (15 fractures) were lost at follow-up period and excluded. Patients were randomly allocated to percutaneous kyphoplasty (75 patients) or conservative treatment by computer-generated randomization codes. All fractures were analyzed for improvement in sagittal alignment (Cobb angle, kyphotic angle, sagittal index, vertebral height); and pain relief at 1, 6, 12, 24 months, as measured by VAS score. RESULTS. Percutaneous kyphoplasty resulted in direct and greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was −6,5 after kyphoplasty and −2.4 after conservative treatment, and between baseline and 1 year was −7.2 after kyphoplasty and −3.8 after conservative treatment. No serious complications or adverse events were reported. Apart from the pain, the patient's ability to ambulate independently and without difficulty, and the need for medications improved significantly (P < 0.001) after kyphoplasty. Vertebral height significantly increased at all postoperative intervals, with 10% height increases in 88% of fractures, in kyphoplasty group at 2 years. There were no severe kyphoplasty-related complications, such as neurological defects, cement leakage or narrowing of the spinal canal whereas additional fractures occurred at the adjacent vertebrae at a rate of 10%. 35% of patients treated conservatively, had limitations in everyday activities the first 6 months, whereas additional fractures occurred at the adjacent vertebrae at a rate of 14%. CONCLUSION. In patients with acute osteoporotic vertebral compression fractures and persistent pain, balloon kyphoplasty is effective and safe. Pain relief after kyphoplasty is immediate, is sustained for at least 2 years, and is significantly greater than that achieved with conservative treatment, at an acceptable cost

The progressive kyphosis and pain in patients with acute thoracolumbar burst fractures treated conservatively so as the recurrent kyphosis after posterior reduction and fixation were associated to disc collapse rather than vertebral body compression. It depends on redistribution of the disc tissue in the changed morphology of the space after fractures of the endplate. The aim of this study is to evaluate the safety and the efficacy of balloon kyphoplasty with calcium phosphate, alone or associated to short posterior instrumentation, in the treatment of acute thoracolumbar burst fractures. Eleven fractures in ten consecutive patients with an average age of 48 years who sustained acute thoracolumbar traumatic burst fractures without neurological deficits were included in this study. The fractures were A1.2 (3), A3.1 (4) and A3.2 (4), according to AO classification. In 7 fractures (A1.2 and A3.1) the kyphopasty was performed alone in order to make the most of efficacy in fracture reduction, anterior and medium column stabilization and, as much as possible, segmental kyphosis correction. In the A3.2 fractures (4), that are unstable, the kyphoplasty was associated to a short posterior instrumentation. To avoid the PMMA long run complications in younger patients, we used a calcium phosphate cement. VAS, SF-36, Roland-Morris questionnaire (RMQ) and Oswestry low back pain disability questionnaire (ODQ) were used to evaluate pain, state of health, functional outcomes and spine disability. To the average follow-up time of 15.5 months (range 8–31) we did not observe statistically significant differences in 7 of 8 SF-36 domains in comparison to general healthy population of same sex and age. At the same follow-up, the spine disability questionnaire showed a functional restriction of 18% (ODQ) and 29,6% (RMQ) being 100% the maximum of disability. No bone cement leakage, no implant failure and no height correction loss were observed in any case. Our data confirm the safety and the efficacy of ballon kyphoplasty with calcium phosphate in the treatment of acute thoracolumbar burst fractures. In this way we can reduce the possible complications resulted from discal space collapse and obtain an early functional restoration. When performed alone, this mini invasive surgical technique offer the advantage of almost immediate return to daily activities. When associated to posterior instrumentation, it decreases the long run complications and allows to reduce the number of stabilized levels, maintaining, in part, the thoracolumbar junction movement

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

BACKGROUND. Osteoporosis with subsequent osteoporotic vertebral compression fractures is an increasingly important disease due not only to its significant economic impact but also to the increasing age of our population. Pain reduction and stabilization are of primary importance with osteoporotic vertebral compression fractures. OBJECTIVE. To compare the efficacy and safety of balloon kyphoplasty and vertebroplasty for the treatment of vertebral compression fractures. MATERIALS & METHODS. From January 2004 to December 2009, 142 patients (32 males and 110 females), from 54 to 84 years old (mean age 67.4) were treated for 185 osteoporotic vertebral fractures of the thoracic or lumbar spine (level of fracture at Th5 or lower), with back pain for more than 8 weeks, and a visual analogue scale (VAS) score of 5 or more. Twenty-two patients (29 fractures) were lost at follow-up period and excluded. Patients were randomly allocated to percutaneous kyphoplasty (64%) or vertebroplasty (36%). All fractures were analyzed for improvement in sagittal alignment (Cobb angle, kyphotic angle, sagittal index, vertebral height). The patients were evaluated using the visual analog scale (VAS) and the Oswestry Disability Score. Radiographs were performed postoperatively, and at 1, 3, 6, and 12 months. RESULTS. The score according to pain, the patient's ability to ambulate independently and without difficulty, and the need for medications improved significantly (P < 0.001) after kyphoplasty or vertebroplasty. No significant difference could be found between both groups for the mean VAS and ODI preoperative and postoperative. Vertebral body height and kyphotic wedge angle of the T-L spine were also improved (p < 0.001); although kyphosis correction seems to be improved better in kyphoplasty than vertebroplasty. The rate of leakage was 12% for kyphoplasty and 32% for vertebroplasty; nevertheless most of the leakage was clinically asymptomatic and the rate of serious problems remained low (pulmonary embolism 0.01% kyphoplasty vs 0.6% vertebroplasty). New fractures in the next 6 months at the adjacent vertebrae were observed ∼ 15% in both groups. More PMMA was used in the kyphoplasty group than in the vertebroplasty group (5.5 +/− 0.8 vs. 4.1 +/− 0.5 mL, p < 0.001). Operation time was longer in balloon kyphoplasty compared to vertebroplasty (mean time 20±5min/vertebral fracture in group B vs 30±5min in group A). CONCLUSION. Both balloon kyphoplasty and vertebroplasty provided a safe and effective treatment for pain and disability in patients with vertebral compression fractures due to trauma or osteoporosis. Balloon kyphoplasty led to an ongoing reduction of fractured vertebrae and was followed by a lower rate of cement leakage

The August 2012 Wrist & Hand Roundup. 360. looks at: the Herbert ulnar head prosthesis; the five-year outcome for wrist arthroscopic surgery; four-corner arthrodesis with headless screws; balloon kyphoplasty for Kienböck's disease; Mason Type 2 radial head fractures; local infiltration and intravenous regional anaesthesia for endoscopic carpal tunnel release; perilunate injuries; and replanting the amputated fingertip

Purpose. To evaluate the complications following percutaneous balloon kyphoplasty and assess the advantage of introducing eggshell technique. Methods and Results. We performed 138 Balloon kyphoplasty procedures in 85 patients during august 2007 to march 2010. Data was collected and analyzed in all these cases. Gender distribution was 60 females and 25 males. Age distribution was 33 to 85 years, with an average age of 67.4 years. Indications of surgery were vertebral fractures due to osteoporosis in 81% of the procedures, trauma in 13% and malignancy in 6%. The most common vertebral levels of the kyphoplasty were at T12 in 32 procedures (23%) and L1 in 28 procedures (20%). Eggshell technique was introduced in 2009 where technical problems were encountered during cementing process. All patients had reduced pain levels, which was assessed by visual analog score. The average length of hospital stay was 2.5 days. Complications were 9 (6.5%) cement leaks (all within one cm from the vertebral body) in procedures performed before the introduction of eggshell technique and no cement leak following the introduction of eggshell technique, 5 (3.6%) fresh fractures, 2 (1.4%) intra-operative fractures and 1 (0.73%) rupture of balloon. There were no complications of cord compression, motor deficit, infection, allergy to cement or pulmonary embolism noted. 30-day mortality rate was zero. Conclusion. Our series had 6.5% incidence of cement leak compared to 11-21% quoted in current literature. Since the introduction of eggshell technique, cement leak rate was reduced to zero%. Hence adopting of eggshell technique during percutaneous balloon kyphoplasty procedure may eliminates the risk of cement leak thereby minimizing complications

Purpose. To elucidate the efficacy of carrying out additional vertebral biopsy procedure during percutaneous balloon kyphoplasty as a tool in determining malignant etiology. Methods and Results. We performed 138 percutaneous balloon kyphoplasty procedures in 85 patients during august 2007 to march 2010. Gender distribution was 25 males and 60 females. Age distribution was 33 to 85 years, with an average age of 67.4 years. The senior surgeon attempted vertebral biopsy during percutaneous balloon kyphoplasty procedure only when there was a clinical/operative suspicion of malignancy. We did not routinely biopsy all vertebrae, as this would mean additional procedure adding to the cost and operating time. In 42 procedures vertebral biopsy was attempted, of which 5 samples were reported as insufficient specimen. 37 biopsies (88%) were successfully analyzed. 3 biopsies (8.1%) were positive for malignancy. There were no complications encountered in the cases where additional biopsy procedure was carried out. Conclusion. There is not much literature supporting routine use and efficacy of biopsies during percutaneous balloon kyphoplasty procedures. Although the quality of bone could make vertebral biopsy challenging in all cases, we feel that improved technique of taking biopsies and maybe increasingly performing the additional biopsy procedure could detect more positive malignancies. Routine biopsies during percutaneous balloon kyphoplasty may be invaluable in diagnosing malignancies

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

Vertebral compression fractures are very common. 250,000 are diagnosed annually in the United States with 80% due to osteoporosis. 1. Symptomatic relief with conservative therapy is often difficult to achieve. The consequence of significant pain is deterioration in quality of life and often in level of function. They independently increase mortality rate. 1. . Balloon kyphoplasty is a relatively new technique which stabilises the vertebral body and restores saggital spinal alignment. Excellent pain relief and improved functional outcome is reported. 2,3. We aim to confirm this. All patients receiving balloon kyphoplasty treatment at Derby Hospitals NHS Trust from April 2006 to August 2010 were entered prospectively onto a database. Visual Analogue Score (VAS) for pain and Oswestry Disability Index (ODI) for function were recorded. Technical data including number of levels, cement volume, screening time and kyphosis correction was recorded. 198 patients underwent balloon kyphoplasty between April 2006 and August 2010. Some data was incomplete. 105 patients had sufficient data for meaningful analysis. 170 levels were operated on in 105 patients. 65% (n=68) of patients were female and the average age was 74. The average pre-operative visual analogue score (VAS) was 8.2. This decreased to 4.0 in the immediate postoperative period. This dramatic improvement remained and was 4.1 at 6 weeks, 3.3 at 6 months and 3.6 at 1 year. The average pre-operative Oswestry disability index (ODI) was 58. This improved to 47 in the immediate post-operative period. At 6 weeks this had improved further to 40 and further improvements were seen at 6 months (ODI 37) and 1 year (ODI 38). Balloon kyphoplasty should be considered in all patients with ongoing pain following an acute vertebral compression fracture that doesn't respond to conservative treatment

Clinical and radiological assessment of results of vertebral body stenting procedure. Introduction: Use of metallic stents along with cement have shown good restoration of the vertebral body in cadaveric spines. We have presented the early results of vertebral body stenting done at Royal Derby Hospitals. Patients and Methods: All patients had a transpedicular approach to the vertebral body. The vertebral body stent was expanded using a balloon as in balloon kyphoplasty. The balloon was removed leaving the stent in place. The resultant cavity was filled with partially cured polymethyl methacrylate in osteoporotic fractures and calcium phosphate cement in traumatic fractures. Radiological assessment included pre operative measurement of vertebral body angle, correction achieved and maintenance of correction at follow up. All patients were assessed using the visual analogue score and oswestry disability index. The procedure was done in 14 fractures (10 patients). 9 fractures were traumatic while 5 were osteoporotic fractures. The mean age of the traumatic fractures was 54.28 years while the mean age of osteoporotic fractures was 82.34 years. Mean follow up was 10 months. All traumatic fractures were type A 3.1. Mean vertebral body angle correction achieved was 8.3° (4° to 14.2°). None of the patients lost the reduction at follow up. The mean VAS for pain at 6 months was 3.8. The mean oswestry disability index was 22% for traumatic fractures, while it was 44% for osteoporotic fractures. Vertebral body stenting is a safe procedure. It was successful in restoring the anterior column with encouraging radiological and clinical results

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. 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)