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

NCT ID: NCT00984672

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2016-04-21

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.

Conditions

Lumbar Degenerative Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Bone morphogenetic protein within an interbody cage

Transforaminal Lumbar Interbody Fusion with the use of BMP

No interventions assigned to this group

Other bone grafting techniques within cage (non-BMP)

Use of iliac crest autograft, allograft, or local autogenous bone grafting within the cage during Transforaminal Lumbar Interbody Fusion.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Nassr

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad Nassr, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

08-008802

Identifier Type: -

Identifier Source: org_study_id