Thoracolumbar corpectomy and stabilization with the icotec KONG®_TL VBR E: A post-market non-interventional clinical investigation in trauma and tumor patients - ico_VBR2021

icotec ag0 个研究点目标入组 71 人开始时间: 2021年12月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patient has a fractured vertebral body due to trauma or a pathologic situation / fracture due to tumorous or metastatic diseases of the spine
•- Vertebral body has to be resected for treatment.
•- Resected level is between T1 and L5, both included.
•- 1-2 levels (contiguous) to be resected
•- Patient is eligible for stabilization with KONG®-TL VBR E in conjunction with supplemental spinal fixation with a posterior pedicle screw and rod system (as listed in the IFU)
•- Patient is at least 18 years old
•- Patient is willing to participate in the postoperative follow-up program and has provided written informed consent
•- ASIA D or E (for trauma patients)

•- Patient has a contraindication to surgery or to any implant systems used in the study (as listed in the IFU).
•- Pre-existing spinal stabilizations in the adjacent segment to the vertebra to be replaced (exception: two-stage surgery)
•- Any kind of psychiatric disorder or condition not allowing to consent for the study
•- Known chronic drug/alcohol abuse
•- Inability to follow the procedures of the study
•- Vulnerable patients

发起方

icotec ag