Background: Balloon kyphoplasty is a minimally invasive treatment for acute vertebral fractures that aims to reduce and correct vertebral deformity by inserting expandable balloon tamps and then stabilize the body by filling it with bone cement. The effect of balloon kyphoplasty on quality of life has not been tested in a randomized trial. Methods: Patients with up to 3 non-traumatic acute vertebral compression fractures were enrolled within 3 months of diagnosis and randomly assigned to receive either balloon kyphoplasty (N=149) or usual nonsurgical care (N=151). Measurements of quality of life, back pain and function, and days of disability and bed rest and spine radiographs were assessed through 12 months of follow-up. Results: Compared with those assigned to nonsurgical care, participants assigned to balloon kyphoplasty had 5.2 points (95% CI, 2.9 to 7.4; p< 0.0001) greater improvement in the physical component of the SF-36 quality of life questionnaire at one month and 1.5 points (95% CI, − 0.8 to 3.8; p=0.2) at twelve months. Those in the balloon kyphoplasty group also had greater improvement in quality of life by the EuroQol questionnaire at one (0.18 points; 95% CI, 0.08 to 0.28; p=0.0003) and twelve months (0.12 points; 95% CI, 0.01 to 0.22; p=0.025) and improved disability by the Roland-Morris scale at one month (4.0 points; 95% CI, 2.6 to 5.5; p< 0.0001) and twelve months (2.6 points; 95% CI, 1.0 to 4.1; p=0.0012). Balloon kyphoplasty patients had less back pain on a 0 to 10-point numeric rating scale at seven days (2.2 points; 95% CI, 1.6 to 2.8; p< 0.0001) and twelve months (0.9 points; 95% CI, 0.3 to 1.5; p=0.0034) and reported fewer days of limited activity at one month (2.9 days per 2 weeks; 95% CI, 1.3 to 4.6; p=0.0004) and twelve months (1.6; 95% CI, − 0.1 to 3.3; p=0.068). Fewer patients assigned to balloon kyphoplasty took pain medications or used walking aids during follow-up. There was no significant difference in the number of patients with adverse events or serious adverse events in the kyphoplasty and nonsurgical groups. New radiographically detected vertebral fractures occurred in 41.8% of subjects in the balloon kyphoplasty and 37.8% in the nonsurgical group (4% difference; 95% CI − 7.5 to 15.6; p=0.5) and were not statistically different. Conclusion: Compared to nonsurgical treatment, balloon kyphoplasty safely improved quality of life and reduced back pain, disability and the use of pain medications and walking aids. Significant improvements in multiple measurements of quality of life, pain and disability continue for at least 1 year. Balloon kyphoplasty did not increase adverse events including the risk of vertebral fractures (Clinicaltrials.gov number, NCT00211211)

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

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

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

Aim: Stabilisation of vertebral bodies by injection of bone cement after osteoporotic fracture is well known for reduction of pain. During the last years the balloon kyphoplasty was introduced for reduction of kyphosis and increase of vertebral height. We investigated the used of this method in vertebral bodies even months after osteoporotic fractures with delayed ossification or unstable non-unions within the vertebral bodies. Methods: These fractures had a median age of 17 weeks. In the magnetic resonance imaging no signs of ongoing bone remodelling were found within the horizontal fracture gaps. In functional x-rays the instability within the vertebral body was proven. During surgery the needle was introduced via a transpedicular or extrapedicular approach and passed straight through the gap of the non-union. In very flat bones this procedure can be more tricky. The balloon was inserted and inflated to decrease the local kyphosis. After removal of the balloon bone cement (PMMA) was filled into the hole to fixate the fragments and stabilize the vertebral body. Results: The Patients had a distinct decrease in pain by preventing the movements within the vertebral body. Life quality measured with the Oswestry disability questionnaire showed a distinct and long lasting increase. Conclusion: In selected cases the balloon kyphoplasty is sufficient to reduce and stabilize vertebral bodies despite of a long period after the fracture

Objective: Effectiveness and safety of Balloon Kyphoplasty as a method of treatment for osteoporotic vertebral fractures of the thoracolumbar spine. Materials and Methods: From January 2003 to December 2008, 102 patients (27 males and 75 females), from 56 to 82 years old (mean age 72) were treated with balloon kyphoplasty procedures for 156 osteoporotic vertebral fractures of the thoracic or lumbar spine, in a mean follow up of 24 months (6 to 45 months). The patients had progressive and painful compression fractures more than 2 months. 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. Vertebral height significantly increased at all postoperative intervals, with ≥10% height increases in 88% of fractures. Morphometric height ratios for treated fractures also significantly increased. 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%. Conclusions: Kyphoplasty provided a safe and effective treatment for pain and disability in patients with vertebral compression fractures due to osteoporosis

Operative treatment of osteoporotic vertebral fractures seems to result in higher primary costs compared to conservative treatment. However it is still unclear whether the inpatient related follow-up costs don’t result in a different outcome. The aim of this analysis was a nationwide comparison of spine related inpatient treatments after balloon kyphoplasty versus conservative treatment of balloon kyphoplasty patients. Materials and Methods: 110 patients after conservative treatment and 141 patients after balloon kyphoplasty treated primarily between 2002 and 2005 in one center were followed up via a nationwide analysis of spine related inhospital treatment. Data from the Austrian DRG-system, which includes all inpatients treated in Austria have been used to identify admission of the target population between 2002 and 2006. Because no unique patient identifier is available in the data set, a matching according to data of birth, gender and postal code was used. Outpatient visits are not included. From these data the number of admissions, the length of stay and the scores can be determined. Furthermore each admission was classified as spine related or not. To calculate the exact follow up times the data were matched against the Austrian death registry. If a patient has died this data was used to calculate the follow up time otherwise December 31st 2006 was used. The mean age of the conservative group was 75.49 and of the kyphoplasty group 71.16 years. The total follow up time was 324.55 years(mean +standard deviation 2.92+−1.40) for the conservative and 354.25 (2.53+−0.96) for the kyphoplasty group. The shorter mean follow up interval for the kyphoplasty group is due to the fact that in the years 2004 and 2005 more patients have been treated by kyphoplasty. Results: The mean number of admissions in the kyphoplasty group is 0.779 or 0.308 per follow up year whereas in the conservative group these figures are approximately twice, namely 1.757 and 0.601. Considering the average length of stay the kyphoplasty group shows less inhospital days (9.2 per patient or 3.6 per follow up year), whereas in the conservative group this is 14.4 and 4.6 inpatient days. Finally the scores per admission in the follow up period are lower in the kyphoplasty group (3146 and 1243 DRG related treatment points) whereas in the conservative group these values are 3824 and 1308. Conclusion: These data show a strong superiority of kyphoplasty compared to conservative treatment of spine problems based on the data of one big hospital in Austria where 251 patients have been treated between 2002 and 2005. We demonstrate a long term superiority of balloon kyphoplasty compared to non-surgical treatment regarding inpatient treatments

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

Objective. To evaluate the outcomes of the treatment of acute thoracolumbar burst fractures by transpedicular balloon kyphoplasty with Calcium phosphate cement and posterior instrumented fusion. Methods: Twenty-three consecutive patients (average age 48 years) who sustained thoracolumbar A3-type burst fracture with or without neurologic deficit were included in this prospective study. Twenty-one out 23 patients had single fractures and the left 2 had each one additional A1 compression contiguous fracture. On admission 5(26%) out 23 patients had neurologic lesion (5 incomplete, one complete). Bilateral transpedicular balloon kyphoplasty was performed with quick hardening calcium phosphate cement to reduce segmental kyphosis and restore vertebral body height and supplementary pedicle screw instrumentation (long including 4 vertebrae for T9-L1 fractures and short (3 vertebrae) for L2 to L4 fractures. Gardner kyphosis angle, anterior and posterior vertebral body height ratio and spinal canal encroachment were calculated pre–to postoperatively. Results: All 23 patients were operated within two days after admission and were followed for at least 24 months after index surgery. Operating time and blood loss averaged 70 minutes and 250 cc respectively. The 5 patients with incomplete neurologic lesions improved by at least one ASIA grade, while no neurological deterioration was observed in any case. Overall sagittal alignment was improved from an average preoperative 16o to one degree kyphosis at final follow up observation. The anterior vertebral body height ratio improved from 0.6 preoperatively to 0.9 (P< 0.001) postoperatively, while posterior vertebral body height was improved from 0.95 to 1 (P< 0.01). Spinal canal encroachment was reduced from an average 32% preoperatively to 20% postoperatively. No differences in preoperative values and postoperative changes in radiographic parameters between short and long group were shown. Cement leakage was observed in 4 cases: three anterior to vertebral body and one into the disc without sequalae. In the last CT evaluation, continuity was shown between calcium phosphate and cancellous vertebral body bone. Posterolateral radiological fusion was achieved within 6–8 months after index operation. There was no instrumentation failure or measurable loss of sagittal curve and vertebral height correction in any group of patients. Conclusions: Balloon kyphoplasty with calcium phosphate cement secured with posterior long and short fixation in the thoracolumbar and lumbar spine respectively provided excellent immediate reduction of posttraumatic segmental kyphosis and significant spinal canal clearance and restored vertebral body height in the fracture level in an equal amount both in short and long instrumentation

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)

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)

80% of myeloma patients have lytic bone lesions and osteoporosis secondary to corticosteroid therapy with high rate of vertebral compression fractures (VCFs). The consequences include pain and spinal deformity. The treatment ideally should address both the fracture-related pain and associated spinal deformity. Kyphoplasty provides a new tool that may impact bone care entailing the insertion and expansion of an inflatable bone tamps (IBT) in a fractured vertebral body. Bone cement is then deposited into the cavity to correct the deformity and improvement in structural integrity of collapsed vertebra. Eighteen VCFs were treated during 11 balloon kyphoplasty procedures in 7 multiple myeloma patients. The clinical outcomes were assessed according to visual analogue scale with 0 representing no pain and 10 severe pain. Patients rated their pain before surgery, 1 week after surgery and at 1 year-postoperative period. Mean improvement in local sagittal alignment was 12.3°. All of the patients who had reached the 1-year postoperative period had reported a high reduction in pain. Treatment with chemotherapy and/or radiation therapy is very important in the control of bone disease. Patients treated with kyphoplasty in combination with pharmacologic therapy return to higher activity levels, leading to increased independence and quality of life

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 circulatory effects of multilevel balloon kyphoplasty (BK) are not adequately addressed, neither the effectiveness of egg shell cementoplasty in preventing anticipated cement leakage in difficult cases. The purpose of this study was to evaluate. the effect of multilevel BK to blood pressure and arterial blood gasses;. the incidence of methylmethacrylate cement leakage using routine postoperative computer tomography scan and. the effectiveness of egg shell cementoplasty to prevent cement leaks. Materials and methods: This is a prospective study of 89 patients (215 vertebral bodies-VBs) with osteoporotic compressive fractures (OCF), and 27 with osteolytic tumors (OT) (88 VBs). The mean age was 67.6 years. 27 patients with OCF were treated at one level, 26 at two, 21 at three, 7 at four, 6 at five, and 2 at six levels at the same sitting. Three patients with OT were treated at one level, 6 at two, 9 at three, 3 at four, 4 at five, and 2 at seven. Egg shell balloon cementoplasty to prevent cement leakage was performed in 10 patients with severe endplate fracture or vertebral wall lytic destruction. Arterial blood pressure and oxygen saturation were monitored during surgery. Arterial blood gases were measured before and 3 min after cement injection. Cement leakage was assessed by the postoperative x rays and computer tomography scans. Results: A drop in blood pressure of more than 25mmHg during cement injection was observed in 6 patients, and was not associated with the number of VB treated. Blood pressure was dropped more than 40mm in 2 patients and the procedure was aborted after completing 1 level in the first and 2 levels in the second. Drop in arterial O2 saturation was noted in 4 patients. One patient treated for 5 levels developed fever and tachepnoea for 24 hours after surgery. Arterial O2 and chest x-rays were normal. Cement leakage was found in 9.7% (21/215) of VBs treated for OCF. Its incidence per location was: epidural, 0.9% (2 VBs); intraforaminal, 0.5% (1 VB); intradiscal, 3.2% (7 VBs); and through anterior or lateral walls, 5.1% (11 VBs). In the OT group cement leakage was found in 10.2% (9/88) of the treated VBs. Its location included 8 (9%) through the anterior or lateral walls and one (1.1%) intradiscal. Cement leakage had no clinical consequences. No cement leakage was observed in cases treated with egg shell balloon cementoplasty. Conclusions: BK is a safe procedure when applied for multiple levels in the same sitting, and its rare circulatory effects are not related to the number of levels treated. The incidence of cement leakage in this study was 10%, which is far less than that reported with vertebroplasty using routine postoperative CT scan. Egg shell balloon cementoplasty can effectively minimize cement leakage in cases with fractured endplate or lytic destruction of VB walls

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

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

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

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

Purpose: The purpose of this study is to evaluate the safety of methylmethacrylate cement balloon kypho-plasty (BK) when applied to five or six levels in the same sitting and the incidence and location of cement leakage.

Methods: Eighty nine patients (215 vertebral bodies-VBs) with osteoporotic compressive fractures (OCF), and 24 with osteolytic tumors (OT) (72 VBs) were treated with BK. Of patients with OCF, 27 were treated at one level, 26 at two, 21 at three, 7 at four, 6 at five, 2 at six levels. Of OT patients, 3 were treated at one level, 5 at two, 9 at three, 3 at four, and 4 at five.

Results: A drop in blood pressure of more than 25mmHg during cement injection was observed in four patients, and was not associated with the number of VB treated. The procedure was aborted in two patients. Otherwise no significant drop in arterial O2 was noted. One patient treated for 5 levels developed fever and tachepnoea for 24 hours after surgery. Arterial O2 and chest x-rays were normal. Pain significantly improved in 95% of patients with OCF and 98% of patients with tumors. In the osteoporotic group, kyphosis correction was achieved in 91% with a mean correction of 7.89°. Cement leakage occurred in 21/215 VBs (9.7%); Epidural: two (0.9%), intraforaminal: 1 (0.5%), intradiscal: 7 (3.2%) while through the anterior or lateral vertebral wall: 11 (5.1%). In the OT group leakage occurred in 6 VBs (8.3%), including 9 (7.0%) through the anterior or lateral wall and one (1.3%) intradiscal. None of the patients had any clinical consequences associated with cement leakage.

Conclusions: BK is a safe and effective procedure, even when applied for 5 or 6 levels. End plate fracture or vertebral wall lytic destruction can effectively be managed by eggshell balloon cementoplasty, thus minimizing the incidence of cement leakage. The incidence of cement leakage with KP (9.8%) is far less than that reported with vertebroplasty, (65.5% shown on CT scans).

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