Spinal Deformity
Conditions
Keywords
spine, deformity, instrumentation, ALIF
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%.
Interventions
DEVICETantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or more of age * planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium
Exclusion criteria
* malignancy * infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision | 12 months | Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure |
Countries
Denmark
Outcome results
None listed