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MAINTAINING SEGMENTAL KYPHOSIS AFTER REMOVAL OF THE INSTRUMENTATION IN PATIENS WITH BALLOON ASSISTED ENDPLATE REDUCTION WITH TRICALCIUM PHOSPHATE BONE CEMENT FOR THORACOLUMBAR BURST FRACTURES.


- candidate number12939
- NTR NumberNTR3498
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jun-2012
- Secondary IDs 
- Public TitleMAINTAINING SEGMENTAL KYPHOSIS AFTER REMOVAL OF THE INSTRUMENTATION IN PATIENS WITH BALLOON ASSISTED ENDPLATE REDUCTION WITH TRICALCIUM PHOSPHATE BONE CEMENT FOR THORACOLUMBAR BURST FRACTURES.
- Scientific TitleMAINTAINING SEGMENTAL KYPHOSIS AFTER REMOVAL OF THE INSTRUMENTATION IN PATIENS WITH BALLOON ASSISTED ENDPLATE REDUCTION WITH TRICALCIUM PHOSPHATE BONE CEMENT FOR THORACOLUMBAR BURST FRACTURES.
- ACRONYM
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedBalloon assisted endplate reduction, Kyphoplasty, Tricalcium phosphate bone cement, Osteoinductive, Osteoconductive, Biocompatibility
- Inclusion criteriaAdult patients who sustaine a fresh traumatic thoracolumbar burst fracture (AO-type A3).
- Exclusion criteriaNeurological deficits, pre-existing spinal deformity, spinal stenosis, osteoporosis (criteria WHO) OR previous spinal surgery.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2011
- planned closingdate1-sep-2012
- Target number of participants15
- InterventionsRemoval of the instrumentation after short-segment pedicle-screw instrumentation and balloon assisted endplate reduction with tricalcium phosphate bone cement for patiŽnts who sustained thoracolumbar burst fractures.
- Primary outcomeStanding 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 ratioís between both the anterior- and the posterior vertebral body height and the central- and posterior vertebral body height are the primay outcomes.
- Secondary outcomeHistological 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.
- TimepointsStanding 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Joep Kitzen
- CONTACT for SCIENTIFIC QUERIESDrs. M.G.M. Schotanus
- Sponsor/Initiator Orbis Medisch Centrum, Orthopedic Department
- Funding
(Source(s) of Monetary or Material Support)
Orbis Medisch Centrum, Department of Orthopedic Surgery
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD25-jun-2012 - 6-jul-2012


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