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

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

BACKGROUND CONTEXT. Osteoporosis causes decreased bone mineral density, which predisposes to fragility fractures. Low-energy vertebral compression fractures are the most common type of osteoporotic fragility fracture. Prior studies have shown that only one-quarter of patients diagnosed with an osteoporotic fracture are referred or treated for osteoporosis. PURPOSE. To identify the rate of recurrent fractures after vertebroplasty and after the conservative treatment for patients aged 50 years and older who sustained low impact vertebral compressions fractures over a 6-month period. STUDY DESIGNED/SETTING. Prospective study. PATIENT SAMPLE. The sample included patients 50 years or older who had a low-energy vertebral compression fracture. The patients were divided into two groups: first group (n=24) - patients teated by vertebroplasty and the second group (n=34) - patients treated conservatory. There was no significant difference among the groups in terms of the vertebral levels or BMD. METHODS. Patients records were reviewed for fracture recurrence and in the same time we examined medical records for osteoporotic medication prescriptions, refferals to endocrinology and to dual-energy X-ray absorptiometry (DEXA) scans. RESULTS. Confounding factors of age at the procedure, sex and chronic steroids use were considered and found to have no statistically significant difference between the two groups and between those with fracture recurrence and those without fracture recurrence. Four vertebroplasty procedure resulted in a recurrent fracture within the first 6 months. In the patient group treated conservatory 8 patients sustained recurrent fractures. Patients with recurrent vertebral fracture didn't receive active osteoporosis treatment. Within 6 months after the fracture only 21% of patients were receiving active osteoporosis treatment. CONCLUSIONS. The incidence of recurrent fracture after vertebroplasty or after conservative treatment is substantial but have no statistically significant difference between the two groups. We consider that the recurrence rate is not related with the surgical intervention but is the result of natural history of the patient's osteoporosis because the patients do not understand the importance of initiating active therapeutic intervention for osteoporosis recommended by physicians

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

Introduction. This study compares outcomes of vertebroplasty(VP) and kyphoplasty(KP) in 125 consecutive female Asian patients above 65 years with L1 osteoporotic vertebral compression fractures. Methods. 57 and 68 patients underwent VP and KP respectively from 2004 to 2008. Outcomes were measured prospectively at pre-operation, 1 month, 6 months and 2 years post-operation by blinded assessors. Radiographic outcome: Anterior, middle and posterior vertebral heights of the L1 vertebral body Functional outcome: Short-Form 36(SF-36) score, Visual Analogue Scale(VAS) score for back pain. Results. There was greater improvement of anterior and middle vertebral heights immediately post-surgery for the KP group as compared to the VP group(P<0.001). At 2 years post-surgery, the KP group had better maintenance of L1 vertebral body height with percentage loss of 16.4%, 17.3% and 8.84% of anterior, middle and posterior vertebral height respectively as compared to the VP group who had a greater loss of 29.2%, 42.3% and 17% respectively(p<0.001). Back pain improved post-operatively in both groups with no significant difference in VAS back pain score between the two groups at each follow-up time point(P>0.05). SF-36 score improved post-operatively in both groups (P=0.001). At 2 years post-surgery, the physical functioning domain of SF-36 was better in the KP group (P=0.01). Conclusion. KP provides better restoration and maintenance of anterior and middle vertebral heights with better physical function outcome”

Background. Radiofrequency Kyphoplasty (RFK) provides a new minimally invasive procedure to treat vertebral compression fractures (VCF). Purpose. The purpose of this study was to investigate the functional outcomes, safety and radiographic outcomes after the treatment of painful osteolytic vertebral fractures treated with a novel minimally invasive procedure, RFK. Material and Methods. 88 patients (50 females and 38 males) with 158 osteolytic vertebral fractures were treated with RFK using the StabiliT Vertebral Augmentation System (Dfine Inc, San Jose, CA). The StabiliT System provides a navigational osteotome to create a site and size specific cavity prior to delivering ultrahigh viscosity cement with an extended working time (done by applying radiofrequency energy to the cement immediately prior to entering the patient). 12 months follow up in 60 patients (36 females and 24 males) with 110 treated vertebrae are reported. Pre- and postoperative, 3, 6 and 12 months clinical parameters (Visual Analogue Scale, Oswestry Disability Index score), and radiological parameters (vertebral height and kyphotic angle) were measured. Results. The median pain scores (VAS) (p<0.001) and the Oswestry Disability Score (p<0.001) improved significantly from pre- to post-treatment and maintained at 3, 6 and 12 months follow up. Postoperative, 3,6 and 12 months follow-up RFK restored and stabilized the vertebral height and avoided further kyphotic deformity. No symptomatic cement leaks or serious adverse events were seen in the RFK group during 3-months of follow up. In 7 out of 158 vertebrae (4.4%) a cement leakage into the disc or lateral wall could be determined by radiograph postoperatively. Conclusion. Radiofrequency Kyphoplasty is a very safe and effective minimally invasive procedure for the treatment of osteolytic vertebral fractures. Radiofrequency Kyphoplasty shows excellent clinical and radiological results in the 3 and 6 months follow up. Site specific cavity creation and delivery of ultra-high viscosity cement in RF Kyphoplasty with extended working time resulted in the added benefits of height restoration and lower cement leakages intra-operatively

Introduction. The main symptoms in multiple myeloma are the result of skeletal destruction mainly the vertebral column. The current treatments for multiple myeloma include radiotherapy and chemotherapy but unfortunately it is still incurable. However, the symptoms and quality of life of these patients can be improved by cement augmentation which has gained popularity in the recent years. Aim. To analyse the efficacy and safety of cement augmentation and to assess the survival and outcome of the patients with vertebral fractures secondary to multiple myeloma. Material and Methods. In this retrospective study, we reviewed the data over the last 3 years. Medical records review included correction of vertebral angle (VA), assessment of disability, survival and postoperative improvement in pain and functional status. Results. We reviewed 12 patients with 48 vertebral compression fractures including 9 male and 3 female patients. Mean age was 62.5 years (41–85). 5 patients had single vertebral involvement while 7 had multiple fractures at different levels in thoracolumbar spine. Average length of follow-up was 20.3 months (14–33 months). Based on Modified Tokuhashi score, the expected survival was less than 12 months in 2 patients and more than 12 months in the remaining patients. 11 patients are alive till date with average survival of 26 months (18–42 months) while 1 patient died, 23 months after the initial correction surgery. Prior to correction, the average vertebral angle (VA) was 10.60 (2.30 to 25.20) and after cement augmentation the average VA was 7.00 (1.60–22.80). Mean correction achieved was 3.60. There was no loss of vertebral height in any patient until their latest follow-up. Karnofsky performance score was more than 70 in 5 patients, 50–70 in 6 and less than 50 in 1 patient preoperatively while it improved to more than 70 in all patients postoperatively which indicates improvement in their functional status. All patients reported improvement in their pain level after surgery. No cement leakage or major complication occurred in these patients. Conclusion. Cement augmentation is a safe and effective way of treating the symptoms of multiple myeloma which occur due to vertebral metastases. It results in excellent pain control and improvement in quality of life

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

We invited 1604 randomly selected women, all 75 years of age, to participate in a study on the risk factors for fracture. The women were divided into three groups consisting of 1044 (65%) who attended the complete study, 308 (19%) respondents to the study questionnaire only and 252 (16%) who did not respond. The occurrence of the life-time fracture was ascertained from radiological records in all groups and by questionnaires from the attendees and respondents.

According to the radiological records, fewer of the questionnaire respondents (88 of 308, 28.6%) and non-respondents (68 of 252, 27%) had sustained at least one fracture when compared with the attendees (435 of 1044, 41.7%; chi-squared test, p < 0.001). According to the questionnaire, fewer of the respondents (96 of 308, 31.1%) had sustained at least one previous fracture when compared with the attendees (457 of 1044, 43.7%; chi-squared test, p < 0.001).

Any study concerning the risk of fracture may attract those with experience of a fracture which explains the higher previous life-time incidence among the attendees. This factor may cause bias in epidemiological studies.