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Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

NCT01601054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-04-19

No results posted yet for this study

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%.

Conditions

  • Spinal Deformity

Interventions

DEVICE

Tantalum cage from Zimmer

A tantalum cage will be inserted through a left sided retroperitoneal approach

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Benny Dahl, MD · University of Copenhagen, Rigshospitalet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01601054 on ClinicalTrials.gov