Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity (SALIF)

Rigshospitalet

Status: Completed

Conditions: Spinal Deformity

Treatments: Device: Tantalum cage from Zimmer

Study type: Interventional

Funder types: Other

Identifiers

NCT01601054

H-2-2012-003

Details and patient eligibility

About

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%.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• malignancy
• infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Anterior lumbar interbody fusion

Active Comparator group

Description:

Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach.

Treatment:

Device: Tantalum cage from Zimmer

Posterior instrumentation alone

Active Comparator group

Description:

Posterior pedicle screw instrumentation

Treatment:

Device: Tantalum cage from Zimmer