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OpenTrials
Completed

NCT Number: NCT01601054

Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

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%.

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Key information

Conditions

Spinal Deformity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine Unit, Rigshospitalet, 9 Blegdamsvej

Copenhagen, Osterbro, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or more of age
  • planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium

Exclusion criteria

  • malignancy
  • infection

Treatment and study plan

Tantalum cage from Zimmer

Device

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

Other names: Tantalum

Primary outcomes

  1. Revision

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: SALIF

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 17, 2012
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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