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…
ID
Bron
Aandoening
balloon assisted endplate reduction, kyphoplasty, tricalcium phosphate bone cement, TCP, biocompatibility, osteoconductive, osteoinductive
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Orbis Medisch Centrum<br>
dr H vd Hoffplein 1
Joep Kitzen
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
j.kitzen@orbisconcern.nl
Wetenschappelijk
Orbis Medisch Centrum<br>
dr H vd Hoffplein 1
Joep Kitzen
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
j.kitzen@orbisconcern.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adult patients who sustaine a fresh traumatic thoracolumbar burst fracture (AO-type A3).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Neurological deficits, pre-existing spinal deformity, spinal stenosis, osteoporosis (criteria WHO) OR previous spinal surgery.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3300 |
| NTR-old | NTR3498 |
| Ander register | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |