No registrations found.
ID
Source
Health condition
balloon assisted endplate reduction, kyphoplasty, tricalcium phosphate bone cement, TCP, biocompatibility, osteoconductive, osteoinductive
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The objective of our study is to evaluate balloon assisted endplate reduction (BAER) with tricalcium phosphate bone cement (TCP) and short-segment instrumentation for thoracolumbar burst fractures. BAER is a relatively new and promising treatment modality. Combined with pedicle fixation, central elevation of the corpus and reduction of the segmental kyphosis is possible. Theoretically, TCP is an attractive bone filler due to its biocompatibility and osteoconductive properties.
The hypothesis of this study is that because BAER, segmental kyphosis can be maintained in even after removal of the short-segment pedicle-screw instrumentation in biological young patients with traumatic thoracolumbar burst fractures. Furthermore biopsies are taken to evaluate the assumed osteoconductive- and osteoinductive properties of the TCP.
Study objective
The hypothesis of this study is that segmental kyphosis can be maintained after removal of the short-segment pedicle-screw instrumentation in biological young patients with traumatic thoracolumbar burst fractures. In these patients in addition to the short-segment pedicle-screw instrumentation, balloon assisted endplate reduction (BAER) with tricalcium phosphate bone cement (TCP) was performed.
Furthermore biopsies are taken to evaluate the assumed osteoconductive- and osteoinductive properties of the TCP.
Study design
Standing anteroposterior and lateral roentgenograms pre- and proximally nine months postoperatively and at latest follow-up after removal of the instrumentation will be obtained. The transpedicular biopsies will be taken during the removal of the instrumentation. During the follow-up after removal of the instrumentation the functional outcomes will be obtained.
Intervention
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 burst fractures.
Orbis Medisch Centrum<br>
dr H vd Hoffplein 1
Joep Kitzen
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
j.kitzen@orbisconcern.nl
Orbis Medisch Centrum<br>
dr H vd Hoffplein 1
Joep Kitzen
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
j.kitzen@orbisconcern.nl
Inclusion criteria
Adult patients who sustaine a fresh traumatic thoracolumbar burst fracture (AO-type A3).
Exclusion criteria
Neurological deficits, pre-existing spinal deformity, spinal stenosis, osteoporosis (criteria WHO) OR previous spinal surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3300 |
| NTR-old | NTR3498 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |