According to the AO principles of fracture management, the fracture of a weight-bearing joint is first reduced then stabilized using fixation.1 The concept of the SpineJack® system is to allow controlled anatomical restoration in order to facilitate early mobilization and weight-bearing.
Anatomical restoration consists of achieving sagittal and coronal balance. These are key factors for kyphosis management and reduction of adjacent level fractures.2-7
Vertebral endplate restoration has been described as having a positive influence on disc creeping, disc degeneration, compensatory curvatures or facet joint arthritis
Studies have shown a correlation between vertebral deformation and clinical problems such as post-traumatic kyphosis, which has been depicted as a serious post-traumatic deformity.3,13
The SpineJack® system is indicated for use in the reduction of mobile spinal fractures that may result from osteoporosis, trauma (fractures types A according to the Magerl classification), and malignant lesions (myeloma or osteolytic metastasis).
The SpineJack® system is intended to be used in combination with validated bone cement, and to be placed, using a transpedicular approach, through a vertebra pedicle with a minimum internal diameter (see the Specifications section of the IFU), as verified with a preoperative CT scan.
The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures and traumatic vertebral compression fractures (type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation. It is intended to be used in combination with Stryker VertaPlex® radiopaque bone cement and VertaPlex® HV radiopaque bone cement.
Refer to IFU for complete instructions and warnings and precautions applicable for devices.
Controlled by specific instrumentation
Implant positioning in both sagittal and transverse planes can help achieve the appropriate fit for the fracture’s shape and the patient’s anatomy.
Controlled by millimetric implants expansion
Millimetric expansion of the implant can be maintained until the bone cement is injected.
PMMA cement positioning and interdigitation
Controlled by PMMA cement fixed pathway
Fixed pathway for the insertion of PMMA cement through the implant helps minimize the possibility of posterior cement spread and risk of leakage into the spinal canal.14
By optimizing PMMA cement positioning and interdigitation, the SpineJack® system provides controlled craniocaudal expansion for anatomical restoration to allow for better functional recovery of the injured disc.15-17
1. 11G access cannula
Insert the 11G access cannula through the pedicle into the posterior one-third of the vertebral body.
Insert the guidewire through the 11G access cannula halfway into the vertebral body, then, remove the tube portion of the 11G access cannula.
Drill into the posterior one-third of the vertebral body. Remove the guidewire. Continue to drill until the desired position of the implant is reached.
Clean the implant site with the template.
Two SpineJack® implants are placed into the vertebral body.
6. SpineJack® expanded (no cement)
The SpineJack® implants are expanded to help reducing the fracture and restore the anatomy.
7. SpineJack® expanded (with cement)
Cement is injected to stabilize the fracture.
Bone cement: serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known to occur beyond a year or more postoperatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.