Evaluation of safety and effectiveness of the Osseofix Spinal Fracture Reduction System in treating spinal compression fractures

Alphatec Spine (UK)0 个研究点目标入组 150 人开始时间: 2012年1月24日最近更新: 2018年5月28日

适应症

试验速览

暂无简介。

•1. Aged 21 years and above
•2. Any male of female patients with vertebral fractures (1-3) caused by osteoporosis, multiple myeloma, or other osteolytic processes
•3. Osteoporosis (primary or secondary)
•4. Fracture levels between T6-L5
•5. Pain VAS =4 (1-10)
•6. Onset of pain within the last 3 months
•7. Recent fractures with bone marrow signal changes on MRI
•8. At least 15% decreased vertebral height compared with adjacent vertebrae
•9. Progressive height loss or painful pseudoarthrosis
•10. VCF morphology suitable for kyphoplasty
•(Fracture types A1.1, A1.2, A1.3 and A 3.1 according to the AO classification)

•1. Age < 21 years
•2. Primary bone tumours
•3. Osteoblastic metastases
•4. Chronic (old) fractures (> 3 months)
•5. Substantial clinical morbidities that preclude the patient from completing the protocol mandated follow-up or which may interfere with the study procedures
•6. VCF morphology unsuitable for kyphoplasty (Pedicle fractures ,unstable burst fractures, spinal injuries in which the pedicles are dissociated from the vertebral body or spinal fractures in which posterior access to the vertebral body is not possible or contra-indicated.)
•7. Neurologic deficit
•8. Inability to complete follow up (medical, cognitive problems)
•9. Prisoners
•10. Pregnancy
•11. Contraindications for MRI
•12. Systemic or local Infection
•13. Patients taking uninterruptive anticoagulation therapy

发起方

Alphatec Spine (UK)