Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4±6.3°; p<0.001), remained at 12 months (-4.4±6.0°, p=0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery

Subaxial Cervical Spine Injuries: Treatment Recommendations of the German Orthopedic and Trauma Society

In a consensus process during four sessions in 2016, the working group lower cervical spine of the German Society for Orthopedic and Trauma Surgery (DGOU), formulated Therapeutic Recommendations for the Lower Cervical Spine, taking into consideration the current literature. Therapeutic goals are a permanently stable, painless cervical spine and the protection against secondary neurologic damage while retaining the greatest possible amount of motion and spinal profile. Due to its ease of use and its proven good reliability, the AOSpine classification for subaxial cervical injuries should be used. The Canadian C-Spine Rule is recommended as a clinical decision rule whether to perform imaging or not. If a structural or unstable injury is suspected by patient history or clinical findings, a spiral CT scan of the cervical spine is the favoured diagnosticmodality. Conventional X-ray is reserved for patients in whom there is no dangerous mechanism of injury. MR imaging is recommended in case of unexplained neurologic deficit, prior to closed reduction and open posterior surgery and to exclude disco-ligamentous injuries. Urgency of MR imaging depends on the specific findings. CT angiography is recommended in higher-grade facet joint injuries or in the presence of vertebra-basilar symptoms. Flexion-extension imaging is recommended only as a physician-guided dynamic fluoroscopy, when an unstable lesion is still suspected. The therapeutic strategy is mainly dependent on morphologic criteria, which are described using the AOSpine classification. A0-injuries are treated conservatively. A1- and A2-injuries are treated conservatively in the majority of cases, and in single cases a gross kyphotic deformity might indicate surgical stabilisation. A3-injuries do indicate a surgical therapy in the majority of cases, but certain cases might be treated conservatively. A4-fractures as well as B- and C-type injuries are to be treated surgically. Most injuries can be treated by anterior plate stabilisation with interbody support; when a complete burst fracture is present, corpectomy and vertebral body replacement is necessary. In certain cases, an additive posterior or pure posterior instrumentation might be possible or even mandatory. In most of these cases, lateral mass screws are sufficient; when pedicle screws are applied in C3 to C6, a 3D-navigation system is recommended. Injuries in an ankylosing spine (M3-modifier) should be treated preferably from posterior with long-segment instrumentation