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

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

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