Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity
NCT ID: NCT01601054
Last Updated: 2016-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-05-31
2015-12-31
Brief Summary
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The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar spine in addition to the usual posterior instrumentation can reduce the revision rate with 50%.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Anterior lumbar interbody fusion
Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach.
Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach
Posterior instrumentation alone
Posterior pedicle screw instrumentation
Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach
Interventions
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Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium
Exclusion Criteria
* infection
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Benny Dahl, MD, PhD
Professor of Spine Surgery
Principal Investigators
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Benny Dahl, MD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen, Rigshospitalet
Locations
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Spine Unit, Rigshospitalet, 9 Blegdamsvej
Copenhagen, Osterbro, Denmark
Countries
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Other Identifiers
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H-2-2012-003
Identifier Type: -
Identifier Source: org_study_id
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