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Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity (SALIF)

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ClinicalTrials.gov Identifier: NCT01601054
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Benny Dahl, MD, PhD, Rigshospitalet, Denmark

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Within the last decade there has been an increase in the number of surgical procedures for deformities of the spine. This is caused by the increase in the elderly population, improved surgical techniques and an increased number of patients who have undergone previous surgical treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities bears a revision rate between 15 and 30% depending on definition, and one of the primary reasons for revision surgery is implant loosening in the lumbosacral region.

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%.


Condition or disease Intervention/treatment Phase
Spinal Deformity Device: Tantalum cage from Zimmer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Supplemental Anterior Lumbar Interbody Fusion in Posterior Instrumented Fusion in Surgical Treatment of Spinal Deformities. A Randomized Study
Study Start Date : May 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tantalum
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Anterior lumbar interbody fusion
Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach.
 Device: Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach
Other Name: Tantalum
Active Comparator: Posterior instrumentation alone
Posterior pedicle screw instrumentation
 Device: Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach
Other Name: Tantalum


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Revision [ Time Frame: 12 months ]
    Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or more of age
  • planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium

Exclusion Criteria:

  • malignancy
  • infection
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601054


Locations
Denmark
Spine Unit, Rigshospitalet, 9 Blegdamsvej
Copenhagen, Osterbro, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Benny Dahl, MD University of Copenhagen, Rigshospitalet
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Benny Dahl, MD, PhD, Professor of Spine Surgery, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01601054     History of Changes
Other Study ID Numbers: H-2-2012-003
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Benny Dahl, MD, PhD, Rigshospitalet, Denmark:
spine
deformity
instrumentation
ALIF

Additional relevant MeSH terms:
Congenital Abnormalities