Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
Study type: Observational What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Scottsdale/Phoenix, Arizona: 08-008802
- Rochester, Minnesota: 08-008802
NCT ID: NCT00984672
Sponsor Protocol Number: 08-008802
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
This study is enrolling participants by invitation only.
- male or female age 18-75
- candidate for TLIF
- Lumbar levels L1-S1
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.