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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00984672

Enrollment

103

Registered

2009-09-25

Start date

2009-03-31

Completion date

2016-04-21

Last updated

2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Degenerative Disease

Keywords

Lumbar Degenerative Disease, Bone Morphogenetic Protein, TLIF

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 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Countries

United States

Outcome results