balloon assisted endplate reduction, kyphoplasty, tricalcium phosphate bone cement, TCP, biocompatibility, osteoconductive, osteoinductive
Conditions
Interventions
Removal of the instrumentation after short-segment pedicle-screw instrumentation and balloon assisted endplate reduction with tricalcium phosphate bone cement for patiënts who sustained thoracolumbar
Sponsors
Department of Orthopedic Surgery, Orbis Medisch Centrum
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients who sustaine a fresh traumatic thoracolumbar burst fracture (AO-type A3).
Exclusion criteria
Exclusion criteria: Neurological deficits, pre-existing spinal deformity, spinal stenosis, osteoporosis (criteria WHO) OR previous spinal surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standing anteroposterior and lateral roentgenograms pre- and proximally nine months postoperatively and at latest follow-up after removal of the instrumentation will be analysed. The wedge angel, the segmental kyphosis angle and the ratio’s between both the anterior- and the posterior vertebral body height and the central- and posterior vertebral body height are the primay outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Histological and histochemical analysis of the transpedicular biopsies from the TCP will be performend. Furthermore Functional outcomes will be determined on the basis of a Visual Analog Pain (VAS) scale, the Short Form-36 score (SF-36) and the Roland Morris Disability Questionnaire score (RDQ) after removal of the instrumentation. | — |
Contacts
Public ContactJoep Kitzen
Department of Orthopedic Surgery Orbis Medisch Centrum dr H vd Hoffplein 1
Outcome results
None listed