Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

Spinal Deformity Clinical Trial

— SALIF  

Official title:

Supplemental Anterior Lumbar Interbody Fusion in Posterior Instrumented Fusion in Surgical Treatment of Spinal Deformities. A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601054
• Other study ID #: H-2-2012-003
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: April 17, 2016
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Commite
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or more of age

• planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium

Exclusion Criteria:

• malignancy

• infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

Intervention

Device:
• Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach

Locations

Country	Name	City	State
Denmark	Spine Unit, Rigshospitalet, 9 Blegdamsvej	Copenhagen	Osterbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision	Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure	12 months	No