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

Lumbar Degenerative Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984672
• Other study ID #: 08-008802
• Status: Completed
• Start date: March 2009
• Est. completion date: April 21, 2016

Study information

• Verified date: April 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 21, 2016
• Est. primary completion date: April 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Degenerative Disease
• Radiculopathy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

External Links

•   Mayo Clinic Clinical Trials