Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity
- Conditions
- Spinal Deformity
- Interventions
- Device: Tantalum cage from Zimmer
- Registration Number
- NCT01601054
- Lead Sponsor
- Rigshospitalet, Denmark
- 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%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 18 years or more of age
- planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium
- malignancy
- infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Posterior instrumentation alone Tantalum cage from Zimmer Posterior pedicle screw instrumentation Anterior lumbar interbody fusion Tantalum cage from Zimmer Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach.
- Primary Outcome Measures
Name Time Method Revision 12 months Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Spine Unit, Rigshospitalet, 9 Blegdamsvej
🇩🇰Copenhagen, Osterbro, Denmark