Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

Not Applicable

Completed

• Conditions: Spinal Deformity

• Registration Number: NCT01601054
• Lead Sponsor: Rigshospitalet, Denmark

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-17
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Revision	12 months	Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure

Trial Locations

Locations (1)

Spine Unit, Rigshospitalet, 9 Blegdamsvej; 🇩🇰 Copenhagen, Osterbro, Denmark