This study prospectively compared the efficacy of kyphoplasty using a Jack vertebral dilator and balloon kyphoplasty to treat osteoporotic compression fractures between T10 and L5. Between 2004 and 2009, two groups of 55 patients each underwent vertebral dilator kyphoplasty and balloon kyphoplasty, respectively. Pain, function, the Cobb angle, and the anterior and middle height of the vertebral body were assessed before and after operation. Leakage of bone cement was recorded. The post-operative change in the Cobb angle was significantly greater in the dilator kyphoplasty group than in the balloon kyphoplasty group (−9.51° (. sd. 2.56) vs −7.78° (. sd. 1.19), p < 0.001)). Leakage of cement was less in the dilator kyphoplasty group. No other significant differences were found in the two groups after operation, and both procedures gave equally satisfactory results in terms of all other variables assessed. No serious complications occurred in either group. These findings suggest that vertebral dilator kyphoplasty can facilitate better correction of kyphotic deformity and may ultimately be a safer procedure in reducing leakage of bone cement

Background. Balloon kyphoplasty has been established as an effective minimal invasive method to treat vertebral fractures of osteoporotic and pathologic etiology. Objectives. Comparative analysis of the clinical and radiographic outcomes of balloon kyphoplasty for treatment of osteoporotic and pathologic vertebral fractures. Study design. Prospective comparative study. Materials-Methods. Twenty five patients (14 women and 11 men) aged (average + SD) 73 + 8 years (range 52–83 years) with vertebral fracture were treated with kyphoplasty and were sampled into three groups: 14 patients (Group A) suffered from osteoporotic fractures and underwent percutaneous kyphoplasty, 5 patients (Group B) suffered from fractures caused from malignancy were treated with percutaneous kyphoplasty, and 6 patients (Group C, hybrid) who underwent combined operation (open kyphoplasty plus instrumented fusion). These patients underwent 25 operations to treat 38 vertebral fractures located between T11 and L5. Preoperative and postoperative radiographs were compared to calculate the changes of vertebral body height ratio (AVBHr, PVBHr) and Gardner kyphotic deformity angle. Sagittal spine alignment was analyzed on whole spine standing radiographs. The VAS, the Oswestry Disability Index (ODI) and the SF-36 surveys were used to evaluate the clinical results. The average time of follow-up was 31.5 + 7 months (range 25–40 months). The average preoperatively SF-36 score (Domain Bodily pain) was 8+ 16, The VAS was 9+1.3 while the ODI was 28+ 17. Results. The average SF-36 (Bodily Pain) score did not significantly differ among the groups and was improved postoperatively to (average, SD) 40+14. VAS improved postoperatively in an similar way in all three groups to 4+1.4 and the ODI was improved in all three groups to 49+ 17, without significant differences among groups. The AVBHr improved significantly only in group A (p=0.01), while there was no change in PVBHr in any group. The Gardner angle improved significantly in groups A (p=0.006) and C (p=0.05) respectively. Discussion. The inflatable bone tamp placed percutaneous or open in combination with spinal instrumentation was efficacious in the treatment of osteoporotic and pathologic vertebral fractures. Kyphoplasty alone or as hybrid was associated with early clinical improvement of pain and function in the treatment of painful pathologic compression fractures, as well as with reduction of Gardner angle

Vertebral haemangiomas are usually asymptomatic and discovered fortuitously during imaging. A small proportion may develop variable degrees of pain and neurological deficit. We prospectively studied six patients who underwent eight surgical procedures on 11 vertebral bodies. There were 11 balloon kyphoplasties, six lumbar and five thoracic. The mean follow-up was 22.3 months (12 to 36). The indications for operation were pain in four patients, severe back pain with Frankel grade C paraplegia from cord compression caused by soft-tissue extension from a thoracic vertebral haemangioma in one patient, and acute bleeding causing Frankel grade B paraplegia from an asymptomatic vascular haemangioma in one patient. In four patients the exhibited aggressive vascular features, and two showed lipomatous, non-aggressive, characteristics. One patient who underwent a unilateral balloon kyphoplasty developed a recurrence of symptoms from the non-treated side of the vertebral body which was managed by a further similar procedure. Balloon kyphoplasty was carried out successfully and safely in all patients; four became asymptomatic and two showed considerable improvement. Neurological recovery occurred in all cases but bleeding was greater than normal. To avoid recurrence, complete obliteration of the lesion with bone cement is indicated. For acute bleeding balloon kyphoplasty should be combined with emergency decompressive laminectomy. For intraspinal extension with serious neurological deficit, a combination of balloon kyphoplasty with intralesional alcohol injection is effective

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

Kyphoplasty is an efficient tool in the treatment of primary tumours (plasmocytoma) and osteolytic metastasis. Especially in plasmocytoma the current chemotherapy has increased life expectancy significantly. Therefore minimal-invasive stabilisation is not only a palliative treatment but really increases quality of life in those cases. Kyphoplasty offers several special tools and techniques to lower the leakage rate which is especially high with other cementoplasty techniques in the osteolytic spine. Materials and Methods: Prospective study of all vertebral tumours compared to osteoporotic fractures treated with kyphoplasty in 2004. 6 months follow up with VAS, SF36 and Oswestry score. Results: In 2004 we performed 67 Kyphoplasties. 12 kyphoplasties were performed in tumour cases (5 plasmocytoma and 7 metastasis). No complications occurred during surgery and during hospital stay. Follow-up included 11 tumours (1 death during F/U) and 46 osteoporotic fractures. 1 patient was treated with combined decompression/kyphoplasty. The pain level (VAS) was significantly reduced in all cases within 2 days (osteoporotic group 2,2 – tumour group 5,4) and reached nearly the same result after 6 weeks which persisted for 6 months (osteoporotic group 1,6, tumour group 2,1). The SF 36/Oswestry Score improved accordingly in both groups. At 6 weeks and 6 months F/U no statistical difference in the scores was seen. Conclusion: Kyphoplasty is a safe treatment method for osteolytic vertebral tumours with vertebral collapse. Clinically the results don’t differ from conventional cases. In cases with canal compromise, a combination with open techniques is possible. Special kyphoplasty techniques allow a reconstruction of the lytic wall and minimise leakage and cement dislocation. Significant improvement of life quality can be achieved offering the spine surgeon a valuable tool in the treatment of spinal metastasis

Purpose of the study: Kyphoplasty was introduced to reinforce the anterior column in osteoporotic vertebral fractures. It can be used for non-osteoporotic fractures. The purpose of this work was to report the clinical and radiographic results of kyphoplasty for non-ostoporotic vertebral fractures. Material and methods: From December 2005 to August 2008, we followed prospectively 21 patients (12 M, 9 F) mean age 45 years (16–58) treated for thoracolumbar fractures by kyphoplasty in order to reinforce the anterior column. There were 23 fractures (T11 = 2, T12 = 5, L1 = 8, L2 = 4, L3 = 4) Magerl: A1 = 6, A3.1 = 7, A3.2 = 1, B1 = 2, B2 = 7. All patients were assessed preoperatively, postoperatively, and at last follow-up with a visual analogue scale (VAS) and the EIFEL function score. The sagittal CT scans passing through the pedicles and the midline were used to measure: the height of the anterior and posterior walls of the fractured vertebra and the supra and infra vertebrae as well as the kyphosis angle. Results: Thirteen fractures were treated by kyphoplasty alone; seven by kyphoplasty combined with percutaneous osteosynthesis; three by kyphoplasty combined with open osteosynthesis with decompression because of preoperative neurological deficits. Mean follow-up was 13 months (6–28). There were no postoperative neurological or infectious complications. At last follow-up, the mean VAS was 1.25 (05) and the mean EIFEL 4 (0–12). Preoperatively, mean compression was 40.9% (6.2–81.4) for the anterior column and 16.7% (0–60.2) for the posterior column. Postoperatively the respective values were 22.8% (5.1–69.3) and 12.3% (−12 to 72.6) for a mean correction of 46.2% for the anterior column and 14.3% for the posterior column. At last follow-up, compression was respectively 26.1% and 7.9%. The vertebral kyphosis was 16.3 (6–16.3) preoperatively and 9.1 (3–4) postoperatively (mean correction 8.7). At last follow-up, vertebral kyphosis was 9.1 (1.7–28.3). Discussion: Kyphoplasty allows satisfactory restoration of vertebral height without loosing short-term correction. For us, kyphoplasty should be associated with posterior fixation in patients with posterior injury. For neurological lesions, kyphoplasty associated with decompression and posterior fixation avoid the need for complementary anterior procedures

Object. Our purpose is to describe a new surgical technique, the transoral kyphoplasty, that we performed in 3 cases of tumors in C2. Materials and Methods. From February 2004 to January 2006 3 cases of C2 tumoral localizations did not show healing after 6 months of conservative treatments. To reduce pain and avoid both C2 collapse and prolonged immobilization transoral kyphoplasties were performed. Results. There were no complications and/or complaints related to the procedure. There were no C2 related symptoms or neurological problems. The first patient died 8 months after surgery due to unrelated causes. The second and the third are alive and, follow ups of 2 years and 8 months respectively, reveal good and pain-free cervical motion, with no findings regarding pathologic mobility/instability on X-ray and CT. Discussion. The management of tumors of the C2 body is still controversial. In cancer patients non-operative treatment could fail. In these cases the literature recommends internal fixation (anterior or posterior), percutaneous vertebroplasty, or transoral vertebroplasty [. 1. –. 4. ]. Anatomically, the transoral route is the most straightforward percutaneous access to the C2 body [. 4. ]. In our cases, after conservative treatment failure, we performed the transoral kyphoplasty to avoid major surgical procedures, and considering kyphoplasty an improvement of the vertebroplasty. While maintaining the normal cervical spine anatomy, and avoiding arthrodesis or fixation that reduce the cervical spine range of motion, in the thoracolumbar spine kyphoplasty versus vertebroplasty is correlated with a reduction in the complication rate [. 5. ]. Conclusions. Transoral kyphoplasty could be considered a safe, quick and effective treatment in reducing pain and avoiding vertebral collapse in patients with tumors in C2, not responding to non-operative treatment

We investigated the safety and efficacy of treating osteoporotic vertebral compression fractures with an intravertebral cleft by balloon kyphoplasty. Our study included 27 patients who were treated in this way. The mean follow-up was 38.2 months (24 to 54). The anterior and middle heights of the vertebral body and the kyphotic angle were measured on standing lateral radiographs before surgery, one day after surgery, and at final follow-up. Leakage of cement was determined by CT scans. A visual analogue scale and the Oswestry disability index were chosen to evaluate pain and functional activity. Statistically significant improvements were found between the pre- and post-operative assessments (p < 0.05) but not between the post-operative and final follow-up assessments (p > 0.05). Asymptomatic leakage of cement into the paravertebral vein occurred in one patient, as did leakage into the intervertebral disc in another patient. We suggest that balloon kyphoplasty is a safe and effective minimally invasive procedure for the treatment of osteoporotic vertebral compression fractures with an intravertebral cleft

Introduction: Minimally invasive augmentation techniques of vertebral bodies have been widely used in the treatment of painful osteoporotic vertebral compression fractures (VBCFs). Kyphoplasty seems to achieve pain relief and improvement in quality of life. However, the effect of kyphoplasty on the height and the kyphotic deformity of the vertebrae is now yet clear. The present study reports our experience in kyphoplasty procedures for osteoporotic VBCF’s. Materials and Methods: A total of 105 VBCF (45 thoracic and 60 lumbar vertebrae) in 56 patients (16 male, 40 female; mean age: 69 years, range 32–87 years) were treated with kyphoplasty between 2002–2005. All patients were preoperatively evaluated with radiographs, MRI and bone scintigraphy, and postoperatively immediately following the procedure and 6 months later with radiographs. Eight patients were treated within a week from their injury (new fractures). All patients completed the Oswestry Disability Index Questionnaire pre- and immediately post-operatively and at 6 months. The height of the treated vertebrae and the kyphotic deformity were measured before, after the kyphoplasty and at 6 months. All procedures were performed under general anaesthesia and fluoroscopy guidance. Results: 54 patients were included in the study; 2 patients expired from causes unrelated to the procedure. All patients experienced pain relief following the procedure and the average Oswestry Disability Index score decreased from 76% preoperatively to 12.4% postoperatively (P< 0.001) and to 18.5% (P< 0.001) at 6 months. The observed mean height restoration at 6 months was 3mm (range 0–15mm) (P=NS) and the kyphotic deformity correction was 3.70 (0–120) (P=NS). In the new fractures the height restoration was 7.1mm and the kyphotic correction 7.80 (P=0.01). There were no cases of pulmonary embolism nor were any significant cement leakages noted. Conclusion: The treatment of painful osteoporotic VBCFs with kyphoplasty is safe and reduces pain and disability. However, it does not lead to restoration of the vertebral height nor to correction of the kyphotic deformity, except in new fractures

Purpose: After vertebroplasty and kyphoplasty the recurrent fracture risk after kyphoplasty is inferior to vertebroplasty, but the risk is still eminent. The reduction of kyphosis is strongly related to the age of the fracture, therefore the reduction and the correction of the kyphosis varies. We investigated the indication of a prophylactic kyphoplasty of adjacent levels to the fracture site in order to decrease the postoperative refracture risk. Methods: Prospective randomized clinical study, 2 groups: monosegmental kyphoplasty versus bi- or mul-tisegmental kyphoplasty with prophylactic level superior to the fracture. F/U 6 months with X-rays. Results: Group 1: monosegmental stabilization: (23 pat. 4 male, 19 female, 23 levels). 5 refractures. 3 refractures adjacent to the kyphoplasty, 2 cases not related to the primary stabilization. In 3 cases cement leakage was seen as direct cause of the refracture. |Group 2: pro-phylactic stabilization (27 pat. - 4 male, 23 female, 27 prophylactic levels). 7 refractures, all adjacent to kypho-plasty. In 3 cases cement leakage as cause of recurrent fracture. No statistical difference between both groups was found, however in 6 out of 12 recurrent fractures we found intradiscal cement leakage as the direct cause of the fracture.|. Conclusions: No statistical difference between both groups (group 1: 22% refracture risk, group 2: 26% refracture risk, p=1). Therefore we do not see the need for a generalized prophylactic stabilization of adjacent levels with kyphoplasty. However, we conclude that it is crucial to avoid any leakage, which has a direct impact on the fracture rate, only in those cases we advise a prophylactic stabilization at the leakage site. In general kyphoplasty is preferable to vertebroplasty due to generally decreased leakage and embolism rate

Introduction Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This paper aimed to compile all available data and evaluate the clinical outcome of the two procedures. The objective was to evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures. Methods This is a systematic review of all the available data presented in peer reviewed published clinical trials (69 papers). Where possible a quantitative aggregation of the data was performed. Data was collected for each study under the headings: general information, participants, intervention, outcomes, complications, and follow-up. Outcome data was collected detailing: pain relief, general health, functional improvements, satisfaction with treatment, and reduction in kyphosis. Complications included: cement leakage (asymptomatic and symptomatic), neurological deficits, cardiovascular, pulmonary and any other clinically relevant complication. Long term follow-up information included all the items recorded under the heading “outcome” with the addition of new fracture details. Results A large proportion of subjects experienced some pain relief (87% vertebroplasty, 92% kyphoplasty). Vertebral height restoration was possible using kyphoplasty (average 6.6°) and for a subset of patients using vertebroplasty. Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are greater than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture. Discussion The pain relief experienced by patients is promising for both kyphoplasty and vertebroplasty in the short term (< 1 year). Leakage of the PMMA is the most common complication and may pose significant danger. Higher leakage rates have been reported for vertebroplasty studies compared to kyphoplasty studies. Particularly kyphoplasty has the ability to reduce the kyphotic angle and restore vertebral height. The critical factor for the restoration of vertebral height would appear to be fracture age

Introduction: Percutaneous kyphoplasty is a minimally invasive, radiologically guided procedure in which bone cement is injected into structurally weakened or destructed vertebrae. In addition to treating osteoporotic vertebral fractures, this technique gains popularity to relieve pain by stabilizing vertebrae compromised by, for example, metastases, aggressive hemangiomas or multiple myeloma that are at risk of pathologic fracture. Materials and Methods: Retrospective study including 44 patients (67 fractures) who undergone percutaneous kyphoplasty from one or several tumoral fractures of the spine between January 2006 and February 2009. 77% were female. The mean age was 67. VAS scale and Karnofsky index were both measured pre and postoperatively. The most frequent lesion found was metastases from a primary tumor followed by myeloma. Results: All patients were seated 24 hours after surgery. Partial or complete pain relief was obtained in 91% of patients (40/44); significant results were also obtained with regard to improvement in functional mobility and reduction of analgesic use. The mean value of the visual analogue scale (VAS) was 5.9 preoperatively, and significantly decreased to 3.3 one day after kyphoplasty. We reported 4 new vertebral fractures and no cases of cement extrusion during the follow-up. We didn’t report any case of neurological dysfunction after surgery. Discussion: Most cases in our study show a significant improvement in pain and functionality with no associated complications. Kyphoplasty cement augmentation has been a safe and effective method in the treatment of symptomatic vertebral neoplasic compression fractures

Introduction: Kyphoplasty is a modification of the basic vertebroplasty technique used to treat osteoporotic vertebral fracture. This study evaluated whether kyphoplasty conferred any short-term mechanical advantage when compared with vertebroplasty. Methods: Pairs of thoracolumbar “motion segments” were harvested from nine spines (42–84 yrs). Specimens were compressed to failure in moderate flexion to induce vertebral fracture. One of each pair underwent vertebroplasty, the other kyphoplasty. Specimens were then creep loaded at 1.0kN for 2 hours to allow consolidation. At each stage of the experiment, motion segment stiffness in bending and compression was determined, and the distribution of compressive “stress” was measured in flexed and extended postures by pulling a pressure- sensitive needle through the mid-sagittal diameter of the disc whilst under 1.5kN load. Stress profiles indicated the intradiscal pressure (IDP), stress peaks in the posterior annulus (SPP), and neural arch compressive load-bearing (FN). Results: Vertebral fracture reduced bending and compressive stiffness by 37% and 55% respectively (p< 0.0001), and IDP by 55%–83%, depending upon posture (p< 0.001). SPP increased from 0.188 to 1.864 MPa in flexion, and from 1.139 to 3.079 MPa in extension (p< 0.05). FN increased from 13% to 37% of the applied load in flexion, and from 29% to 54% in extension (p< 0.001). Vertebroplasty and kyphoplasty partially reversed these changes, and their immediate mechanical effects were mostly sustained after creep-loading. No differences were found between vertebroplasty and kyphoplasty. Conclusion: Kyphoplasty and vertebroplasty are equally effective in reversing fracture-induced changes in motion segment mechanics. In the short-term, there is no mechanical advantage associated with kyphoplasty

Osteoporotic vertebral fractures predispose to significant morbidity in the elderly and are strongly associated with an overall decline in health, functional status and social drift. In recent years various surgical morphoplastic techniques have been employed in an attempt to improve on the disappointing natural history of this manifestation of biological failure. Current evidence supporting the use of kyphoplasty versus medical management alone in the management of these factures is limited and based on several small prospective cohort studies. We present prospectively collected data supporting the use of kyphoplasty in a U.K. based population tested by examining Visual Analogue Pain Score (VAS), vertebral height, vertebral and kyphosis angles, Oswestry Disability Index and Hospital Anxiety and Depression Score (HADS). 50 patients in our kyphoplasty group have undergone 91 kyphoplasty procedures. With a mean follow up of 6 months, the mean post-operative VAS score was 3.8 versus a pre op score of 8.5. This reduction was maintained at 6 weeks and 6 months with mean scores of 3.3 and 2.7 respectively (p< 0.001). Functional status ODI scoring improved from a pre-operative score of 54 to 47 post-operatively, to 40 at 6 weeks, and further, to 39 at 6 months. This result was reinforced by HADS scoring at the same time intervals recording 15.0, 11.2, 11.1 and 11.7 respectively. Post-operative radiographs demonstrated a 24% mean increase in the vertebral angle (p< 0.01) with increases in the anterior, middle and posterior vertebral body heights of 19, 31 and 9% respectively (p< 0.001). No significant improvement of kyphosis angle was identified. The Derby experience demonstrates that kyphoplasty can improve pain and functional status and may help correct deformity after osteoporotic vertebral compression fractures. Our experience has encouraged further recruitment for kyphoplasty as the preferred management for those patients who fail to respond to initial non-operative management

Osteoporotic vertebral fractures predispose to significant morbidity in the elderly and are strongly associated with an overall decline in health, functional status and social drift. Current evidence supporting the use of kyphoplasty versus medical management alone in the management of these factures is limited and based on several small prospective cohort studies. These published case series report the use of several end points, variously including Visual analogue score (VAS), Vertebral height, kyphosis angle and Oswestry disability index (ODI). We present prospectively collected data supporting the use of kyphoplasty in a U.K. based population tested by examining VAS, vertebral height, vertebral and kyphosis angles, ODI and hospital anxiety and depression score (HADS). 40 patients in our kyphoplasty group have undergone 70 kyphoplasty procedures. With a mean follow up of 6 months, the mean post-operative VAS score was 3.9 versus a pre op score of 8.5. This reduction was maintained at 6 weeks and 6 months with mean scores of 3.7 and 3.8 respectively. Functional status ODI scoring improved from a pre-operative score of 53 to 48 post-operatively, to 42 at 6 weeks, and further, to 41 at 6 months. This result was reinforced by HADS scoring at the same time intervals recording 15.3, 12.0, 10.1 and 11.3 respectively. Post-operative radiographs demonstrated a 24% mean increase in the vertebral angle with increases in the anterior, middle and posterior vertebral body heights of 26, 40 and 11 % respectively. Kyphosis angle has been improved by a mean angle of 2 degrees. The Derby experience demonstrates that kyphoplasty can improve pain and functional status and may help correct deformity after osteoporotic vertebral compression fractures. Our experience has encouraged further recruitment for kyphoplasty as the preferred management for those patients who fail to respond to initial non-operative management

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)

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

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 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

Purpose: A complete collapse of osteoporotic vertebral fractures is difficult to treat. Restoration of vertebral height is very difficult, if ever possible. Kyphoplasty has been shown to restore vertebral compression fractures; however the best results are achieved in fractures without total collapse. Nevertheless some fractures develop osteonecrosis and pseudarthosis which can be easily seen on X-ray. For those cases we performed a retrospective study in order to evaluate the capacity of kyphoplasty in those difficult situations. Methods: We analyzed the pre- and postoperative X-rays of vertebra plana treated between 2002 and 2005. Vertebral height (vh -anterior, middle and posterior) and kyphotic angle were measured with a digital imaging system. 2 independent examiners classified the preoperative X-rays into fractures with osteonecrosis/pseud-arthrosis (group 1) and without osteonecrosis (group 2). Statistical analysis with the non-parametric Mann-Whitney test was performed. Results: Between 2002 and 2005 we performed 315 kyphoplasties. A total collapse of the vertebra (vertebra plana) was treated in 15 cases. Mean age 76 years, SD 5.2 years, average time of treatment after fracture 4 months. Osteonecrosis was persistent in 8 cases. The osteonecrosis group found a statistically significant higher degree of vertebral reconstruction (p < 0.013 - group 1: anterior vh 33%, middle vh 37,8%, posterior vh 19,1%; group 2: anterior vh 4,9%, middle vh 17,5%, posterior vh 1,8%). No significant difference was found in the analysis of the pre- and postop. kyphotic angle which could be due to the small sample size as the mean values are three-fold elevated in group 1 (p = 0.146, group 1: restoration mean 9,1° - maximum 18°; group 2: restoration mean 3,5° - maximum 13°). Conclusions: Osteonecrosis is a positive predictive sign for the potential of vertebral reconstruction. Vertebral height can be significantly improved in those patients and the major changes of the kyphotic angle are possible. Even after 4 months, correction of the deformity is possible with kyphoplasty. However, without this sign, restoration of the vertebral height and correction of kyphosis is limited to rare cases