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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01601054
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
43
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Tantalum cage from Zimmer
 N/A

Study Design

Study Type:
Interventional
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 1, 2012
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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 Names:
  • 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 Names:
  • Tantalum

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Revision [12 months]

      Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spine Unit, Rigshospitalet, 9 Blegdamsvej Copenhagen Osterbro Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: Benny Dahl, MD, University of Copenhagen, Rigshospitalet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Benny Dahl, MD, PhD, Professor of Spine Surgery, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT01601054
    Other Study ID Numbers:
    • H-2-2012-003
    First Posted:
    May 17, 2012
    Last Update Posted:
    Apr 19, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Benny Dahl, MD, PhD, Professor of Spine Surgery, Rigshospitalet, Denmark
    spine
    deformity
    instrumentation
    ALIF
    Additional relevant MeSH terms:
    Congenital Abnormalities

    Study Results

    No Results Posted as of Apr 19, 2016