Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT05456633 |
Other study ID # |
CAS-031 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 2023 |
Est. completion date |
August 2026 |
Study information
Verified date |
September 2023 |
Source |
K2M, Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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 utilizing Stryker Capri Corpectomy Cages.
The primary study hypothesis to determine effectiveness, is that the mean improvement in NDI
(cervical) or ODI (thoracolumbar) score from baseline meets or exceeds 15-points at 24 months
for Stryker Capri Corpectomy Cage systems individually.
Description:
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.