Eral anaesthesia, a bipedicular approach into the affected vertebra is chosen with insertion of specially designed metallic sleeves to guide the electron drift tube of the miniature x-ray generator (intrabeam®). buy cheap viagra To perform the iort during a kyphoplasty with this device a new applicator was designed. buying viagra from canada reviews This sterile applicator consists of a plastic head, which is needed to attach it to the x-ray source and a stainless steel tube. generic viagra without prescription This tube protects the probe from bending. viagra viagra compare Under fluoroscopic guidance the applicator including the drift tube is guided through the metallic sleeves in the vertebral body. canada viagra online A dose of 8 gy in 5 mm distance is delivered. After iort the intrabeam system is removed. The kyphoplasty balloon is inflated and pmma-cement is injected. buy viagra online Afterwards the sleeves are removed and the wound is closed as usual. Aim of this study is the definition of the maximum tolerable dose (mtd) for iort during a kyphoplasty using specific mtd-criteria and evaluating the effectiveness of this combined treatment procedure. is generic viagra available over the counter To determine the mtd 3 levels with increasing doses are planned: 8 gy in 5 mm distance, 8 gy in 8 mm distance and 8 gy in 10 mm distance. cheap viagra pills free shipping Condition intervention phase tumors radiation: intraoperative radiotherapy phase 2 study type: interventional study design: endpoint classification: safety/efficacy studyintervention model: single group assignmentmasking: open labelprimary purpose: treatment official title: kypho-iort: phase ii study for dose escalation of intraoperative radiotherapy during kyphoplasty for spinal metastases resource links provided by nlm: medlineplus related topics: cancer u. viagra pills S. cheap viagra 40 mg Fda resources further study details as provided by university hospital mannheim: primary outcome measures: side effect of iort using defined mtd criteria: dysfunction of wound healing, infections, osteoradionecrosis, nerve and spinal cord damage, pathological fracture within 90 days [ time frame: 5 years ] [ designated as safety issue: no ] secondary outcome measures: efficacy defined by ct or mr-imaging and / or clinical relapses / progress and pain [ time frame: 5 years ] [ designated as safety issue: no ] estimated enrollment: 18 study start date: january 2011 estimated study completion date: december 2018 estimated primary completion date: december 2013 (final data collection date for primary outcome measure) intervention details: radiation: intraoperative radiotherapy intraoperative radiotherapy (8 gy) during kyphoplasty for spinal metatsases   eligibility ages eligible for study:   50 years and older genders eligible for study:   both accepts healthy volunteers:   no criteria inclusion criteria: ≥ 50 years karnofsky index ≥ 60 histological or by imaging proven spinal metastases (2 cm diameter as the upper limit) inferior th 3, which are accessible for kyphoplasty written informed consent obtained use of adequate contraceptive method by female patients of reproductive potential t. viagra samples
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