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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Benny Dahl, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01601054
First received: May 14, 2012
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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 Intervention
Spinal Deformity
Device: Tantalum cage from Zimmer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Revision [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601054

Contacts
Contact: Benny Dahl, MD + 4535453545 bennydahl@gmail.com

Locations
Denmark
Spine Unit, Rigshospitalet, 9 Blegdamsvej Recruiting
Copenhagen, Osterbro, Denmark, 2100
Contact: Benny Dahl, MD    +4535453545    bennydahl@gmail.com   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Benny Dahl, MD University of Copenhagen, Rigshospitalet
  More Information

No publications provided

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
Study First Received: May 14, 2012
Last Updated: May 15, 2012
Health Authority: Denmark: Ethics Commite

Keywords provided by Rigshospitalet, Denmark:
spine
deformity
instrumentation
ALIF

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014