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)

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

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