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Clinical Trials/NCT01601054
NCT01601054
Completed
Not Applicable

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

Rigshospitalet, Denmark1 site in 1 country30 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Deformity
Sponsor
Rigshospitalet, Denmark
Enrollment
30
Locations
1
Primary Endpoint
Revision
Status
Completed
Last Updated
10 years ago

Overview

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%.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Benny Dahl, MD, PhD

Professor of Spine Surgery

Rigshospitalet, Denmark

Eligibility 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

Outcomes

Primary Outcomes

Revision

Time Frame: 12 months

Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure

Study Sites (1)

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