Spinal Deformity Clinical Trial
— SALIFOfficial title:
Supplemental Anterior Lumbar Interbody Fusion in Posterior Instrumented Fusion in Surgical Treatment of Spinal Deformities. A Randomized Study
Verified date | April 2016 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Commite |
Study type | Interventional |
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%.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years or more of age - planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium Exclusion Criteria: - malignancy - infection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Spine Unit, Rigshospitalet, 9 Blegdamsvej | Copenhagen | Osterbro |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Revision | Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure | 12 months | No |
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