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
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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 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 |

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.
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Device: Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach
Other Name: Tantalum
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Active Comparator: Posterior instrumentation alone
Posterior pedicle screw instrumentation
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Device: Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach
Other Name: Tantalum
|
- Revision [ Time Frame: 12 months ]Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years or more of age
- planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium
Exclusion Criteria:
- malignancy
- infection

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
Denmark | |
Spine Unit, Rigshospitalet, 9 Blegdamsvej | |
Copenhagen, Osterbro, Denmark, 2100 |
Principal Investigator: | Benny Dahl, MD | University of Copenhagen, Rigshospitalet |
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 |