Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar Corpectomy Cage Systems

Online since 10 November 2022, updated 473 days ago

About this trial

This is a retrospective and prospective observational, multi center study of subjects who have undergone or will undergo vertebral body replacement surgery in the cervical or thoracolumbar spine utili...

Included participants

Gender
All
Age
All ages
Injury level
Level not specified
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Observational

    Details

    Corpectomy procedures are utilized to treat a variety of spinal pathologies including tumor, often as a result of metastatic spine disease, fracture frequently attributed to trauma, osteomyelitis (infection), and degenerative disorders which require reconstruction to achieve decompression of the spinal cord or neural tissues. Patients may present with pain, spinal instability, and neurological deficits. Corpectomy involves a resection or excision of the affected vertebrae and intervertebral disc(s), followed by placement of a vertebral body replacement (VBR) to reconstruct the anterior column of the spine and restore stability and alignment. Common indications for VBR procedures include spinal instability due to vertebral fractures, vertebral compression fractures, and fractures related to malignancy or infection and control of disease, such as metastatic disease in the spine. Causes of spinal fractures may include falls, sports, and motor vehicle accidents. Spinal tumors are often caused by metastases of the skeletal system, which commonly affect the spine. Additionally, VBR procedures may be considered in response to cervical spondylotic myelopathy which is a progressive degenerative disease and a common cause of cervical spinal cord dysfunction and cervical myelopathy in people over the age of 55. Corpectomy (or vertebrectomy) with reconstruction has become a common surgical procedure used for decompression and reconstruction of the spine. Traditionally, reconstruction has included autograft, allograft, and bone substitutes; however, the use of grafts alone have been reported to lead to complications such as donor site morbidity, high rates of pseudarthrosis, and delayed union. The evolution of corpectomy cages has led to improvements in both clinical and radiographic outcomes. Titanium mesh cages were one of the earliest types of non-graft-based corpectomy cages, providing a biocompatible method of rapidly stabilizing the affected segments, reducing donor site morbidity, and improving outcomes. This study will examine use of the Capri Corpectomy Cage systems in cervical and/or thoracolumbar cases in the treatment of trauma, tumor, infection (cervical only), or degeneration (cervical only) using static (cervical only) or expandable (cervical and thoracolumbar) cages. Clinical efficacy and safety will be assessed in this post-market study through evaluation of patient outcomes in comparison to baseline, pre-operative conditions. Capri Corpectomy system implants are VBR devices that are designed in a variety of lengths, widths, and heights to match the patient's anatomy. The caudal and cephalad ends of the implant have teeth which are designed to engage with the vertebral body endplates. The side walls of the implants contain windows that may be used for graft incorporation. Instruments are used for inserting the associated implant components using standard surgical techniques. There are curettes, scrapers, and box chisels for preparing the disc spaces and vertebral body endplates. Insertion instruments are available for inserting the implant. Capri Corpectomy Cage systems are available as cervical static cages (comprised of titanium alloy) and cervical or thoracolumbar adjustable (i.e., expandable) cages (comprised of titanium alloy and cobalt chrome). Devices may be implanted via posterior, anterior, or lateral approaches.

    Potential benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

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    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Oct 2023
    • Organisation
    • K2M, Inc.
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Oct 2023
    • Organisation
    • K2M, Inc.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more