Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery

Study Overview
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Brief Summary
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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 arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT Cage, other clinical applications of these proteins is becoming widely adopted due to their effectiveness in forming bone and facilitating fusion. Clinicians have realized while these proteins are potent stimulators of bone formation there have been anecdotal reports of increased rates of radicular pain in the postoperative period when used in interbody arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to be due to the inflammatory effects of these proteins. Excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. No prospective studies have been performed assessing the incidence and etiology of this complication. The investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.

Official Title
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Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery

Conditions
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Lumbar Degenerative Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female age 18-75 candidate for TLIF Lumbar levels L1-S1 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bone morphogenetic protein within an interbody cage<br>Transforaminal Lumbar Interbody Fusion with the use of BMP | |
| Other bone grafting techniques within cage (non-BMP)<br>Use of iliac crest autograft, allograft, or local autogenous bone grafting within the cage during Transforaminal Lumbar Interbody Fusion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Degenerative Disease, Bone Morphogenetic Protein, TLIF