Status:
COMPLETED
Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
Lead Sponsor:
Mayo Clinic
Conditions:
Lumbar Degenerative Disease
Eligibility:
All Genders
18-75 years
Brief Summary
Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved, has increased recently due to the morbidity associated with harvest of iliac crest bone graft in spinal ar...
Eligibility Criteria
Inclusion
- male or female age 18-75
- candidate for TLIF
- Lumbar levels L1-S1
Exclusion
- more than 3 TLIF levels
- had a previous fusion attempt at involved level(s)
- had more than 2 previous open, lumbar spine procedures at the involved level(s)
- currently implanted with anterior instrumentation at the involved level(s)
- BMI \>40
- active localized or systemic infection
- presence of a disease entity or condition which significantly affects the possibility of bony fusion
- has immunosuppressive disorder actively requiring treatment
- pregnant or interested in becoming pregnant during the study
- has a known sensitivity to device materials
- mentally incompetent or is a prisoner
- currently a participant in another study for the same indications
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 21 2016
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00984672
Start Date
March 1 2009
End Date
April 21 2016
Last Update
April 15 2022
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905