Prospective multicenter study with a new implant for thoracolumbar vertebral body replacement

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Background:There are several therapeutic strategies for restoring the anterior column of the vertebral body after trauma, tumor and infection. We present a multicenter study with a new distractable titanium implant for vertebral body replacement.Methods:Prospective documentation was collected of the first 126 patients treated with Synex during the 1st year of the clinical course. There was an evaluation of surgical indication, classification, localisation of the lesion, operative details, complications, and clinical course.Results:A total of 70 men and 56 women (average age 46.9 years) underwent surgery for vertebral fracture, correction of posttraumatic kyphosis, infection, vertebral tumor and metastasis, and other diseases such as ankylosing spondylitis. Synex was used in open and minimally invasive surgery. In almost every case, an additional anteriorly or posteriorly stabilizing implant was used. Anterior fusion was performed with cement in tumors and autologous bone in fractures. Monoand multisegmental lesions in the thoracic and lumbar spine were treated.Conclusions:The Synex implant is very easy to manage and is suitable for many indications such as vertebral fracture, correction of posttraumatic kyphosis, infection, vertebral tumor/metastasis, and other diseases. The vertebral body replacement can be used for defects of different sizes with the option of in situ distraction. No cases of implant failure, dislocation, or other implant-related complication have been observed. As a consequence of this prospective series, an additional implant size has been added, and the distraction device (spreading forceps) has been modified for more powerful spreading.

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