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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Benny Dahl, MD, PhD, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01601054

First received: May 14, 2012

Last updated: April 17, 2016

Last verified: April 2016

History of Changes

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 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

Resource links provided by NLM:

Drug Information available for: Tantalum

U.S. FDA Resources

Further study details as provided by Benny Dahl, MD, PhD, Rigshospitalet, Denmark:

Primary Outcome Measures:

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


Enrollment:	30
Study Start Date:	May 2012
Study Completion Date:	December 2015
Primary Completion Date:	December 2015 (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 (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

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

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


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:	April 17, 2016

Keywords provided by Benny Dahl, MD, PhD, Rigshospitalet, Denmark:


spine deformity instrumentation ALIF

Additional relevant MeSH terms:


Congenital Abnormalities

ClinicalTrials.gov processed this record on September 20, 2017

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