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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior lumbar interbody fusion | Active Comparator | Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach. |
|
| Posterior instrumentation alone | Active Comparator | Posterior pedicle screw instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tantalum cage from Zimmer | Device | A tantalum cage will be inserted through a left sided retroperitoneal approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision | Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benny Dahl, MD | University of Copenhagen, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Unit, Rigshospitalet, 9 Blegdamsvej | Copenhagen | Osterbro | 2100 | Denmark |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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