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



Status:Active, not recruiting
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:3/8/2019
Start Date:March 2009
End Date:December 2020

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

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.


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
We found this trial at
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Rochester, Minnesota 55905
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Rochester, MN
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