investigating bone cement with or without inossia™ cement softener for vertebral compression fractures

Conditions: Vertebral Compression Fracture

Summary: the overall purpose of conducting this study is to evaluate the safety and efficacy of v-flex and v-steady for augmentation of osteoporotic vertebral compression fractures and to verify that adding a cement softener into a pmma bone cement is comparable to a pmma bone cement alone (v-steady).

the clinical investigation is a prospective, single-blind, controlled multi-center study of vertebral compression fractures treated by vertebroplasty or kyphoplasty with pmma alone (v-steady) or pmma mixed with inossia™ cement softener (v-flex). the overall purpose of conducting this study is to confirm the safety and efficacy of inossia™ cement softener mixed with pmma for augmentation of osteoporotic vertebral compression fractures and to verify that the v-flex is, at least, comparable (non-inferior) to the pmma products used today. all eligible patients will be invited to participate in the study. a total of 150 patients will be enrolled in the study.

Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities (study-related activities are any procedures that would not have been performed during normal management of the patient, i.e. standard of care); * symptomatic osteoporotic vertebral compression fracture without prior or not responding to medical treatment within 6 months; * maximum of 1 level of vertebral compression fractures eligible for treatment localized at level th5 to l5 and verified by mri or bone scan; * height reduction of the affected vertebra(e) with an anterior wall compression of not exceeding 60% compared to the nearest normal vertebral body determined by x-ray; * have pain correlating to the fractured levels requiring regular analgesic intake and/or causing substantial disability of daily life; * pain score ≥ 40 mm measured by vas correlating to at least one of the fracture levels (scale 0 - 100 mm) at the screening visit; * oswestry disability index \> 20 (0 - 100 scale); * sf-12pcs index \< 80 (0 - 100 scale); * patient with a communicative ability to understand the procedure and participate in the study and comply with the follow up program. exclusion criteria: * patients below 18 years; * any burst fracture; * unstable fractures defined by neurological deficit or interspinous process widening as evaluated by the investigator, as well as kyphosis \> 30°, translation \> 4 mm; * established or suspected malignancy of the fractured vertebra. hemangioma of the fractured vertebra; * high energy trauma or clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis as suggested by progressive weakness; * have neurologic symptoms or deficits, or radiculopathy related to the fractured vertebrae; * patients with extremely high bmi, i.e. bmi ≥ 40; * previously treated with vertebroplasty or kyphoplasty; * patients with concomitant diseases which may be worsened by invasive treatment of the fracture such as e.g. severe cardiopulmonary dysfunction (including aortic aneurysm), as judged by the investigator * irreversible coagulopathy or bleeding disorder. note regarding reversible coagulopathies: patients on coumadin or other anticoagulants may participate. investigators should follow routine practices for perioperative discontinuation and re- initiation of anticoagulants; * active systemic infection or local skin infection at the puncture site; * pregnancy or breast-feeding; * patients with known chemical dependency or drugs or with a medical history of drug abuse; * patients who are serving prison sentence; * have participated in another investigational study within 30 days prior to inclusion * pacemaker * previous or active radiotherapy affecting the spine

Keywords: vertebral compression fracture bone cement vertebroplasty kyphoplasty osteoporosis softener