Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar … (NCT05456633) | Clinical Trial Compass
WithdrawnNot Applicable
Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar Corpectomy Cage Systems
Stopped: The study has been withdrawn and no participant was enrolled.
0Started 2023-10
Plain-language 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.
Who can participate
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Inclusion Criteria:
* Skeletally mature
* Willingness and ability to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study specific informed consent form. For fully retrospective enrollments, i.e., subjects that already have 24-month follow-up data available, the Principal Investigator will request a waiver of the written informed consent requirement.
* Has undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) using either Capri Cervical 3D Static OR Capri Cervical 3D Expandable to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders -OR- Has undergone or will undergo VBR in the thoracolumbar spine (T1 to L5) using Capri Thoracolumbar Expandable to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture)
* Score at least 30 points on the ODI or at least 30 points on the NDI at screening (or before surgery for retrospective enrollment) (on a 100-point scale)
Exclusion Criteria:
* Presence of infection, except within the spinal indications for use of this product
* Pregnancy (pregnant at the time of enrollment or intends to become pregnant during the course of the study)
* Metabolic disorders of calcified tissues
* Grossly distorted a…