trauma or tumor damaged vertebral body in the thoracic or lumbar spine
Conditions
Interventions
Group 1: Patients in need of a vertebral body replacement die ewill be treated with KONG®-TL VBR E and their health status (via questionnaires), and the behavior of the vertebral body replacement devi
Sponsors
icotec ag
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patient has a fractured vertebral body due to trauma or a pathologic situation / fracture due to tumorous or metastatic diseases of the spine - Vertebral body has to be resected for treatment. - Resected level is between T1 and L5, both included. - 1-2 levels (contiguous) to be resected - Patient is eligible for stabilization with KONG®-TL VBR E in conjunction with supplemental spinal fixation with a posterior pedicle screw and rod system (as listed in the IFU) - Patient is at least 18 years old - Patient is willing to participate in the postoperative follow-up program and has provided written informed consent - ASIA D or E (for trauma patients)
Exclusion criteria
Exclusion criteria: - Patient has a contraindication to surgery or to any implant systems used in the study (as listed in the IFU). - Pre-existing spinal stabilizations in the adjacent segment to the vertebra to be replaced (exception: two-stage surgery) - Any kind of psychiatric disorder or condition not allowing to consent for the study - Known chronic drug/alcohol abuse - Inability to follow the procedures of the study - Vulnerable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stability of the motion segment (bisegmental kyphotic angle (BKA)) measured as radiographic parameter at 24 months compared to baseline (0-8 days postop). The assessment is done based on x-rays by the indepentent central data assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary performance outcomes will be analyzed (descriptive only): - Responder rate: proportion of patients achieving a BKA change of <5° between 0-8d and 24m post-operative - BKA at the perioperative and each postoperative visit - PROST score (for trauma patients only) - Karnofsky-Index (KPSS) (for tumor patients only) - Post-operative COMI - NRS pain - Segmental height - VBR collapse absolute values - VBR collapse preservation of values over time - Fusion rate based on 12 months CT The following secondary safety outcomes will be analyzed: - Device subsidence - Device migration - Description of Serious Adverse Device Effects (SADEs) | — |
Countries
Germany, Switzerland
Contacts
Public ContactArmando Gisep
icotec ag
Outcome results
None listed