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.

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Key information

Conditions

Lumbar Degenerative Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: Sep 25, 2009
Registry last updated: Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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