Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

Rigshospitalet, Denmark30 enrolled

Overview

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Spinal Deformity

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or more of age * planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium Exclusion Criteria: * malignancy * infection

Locations (1)

Spine Unit, Rigshospitalet, 9 Blegdamsvej

Copenhagen, Osterbro, Denmark

Outcomes

Primary Outcomes

Revision

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

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.