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

NCT00984672 | Completed

• 1 other identifier: 08-008802
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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

Keywords

Lumbar Degenerative Disease; Bone Morphogenetic Protein; TLIF

Study Arms (2)

Bone morphogenetic protein within an interbody cage

Transforaminal Lumbar Interbody Fusion with the use of BMP

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients age 18-75 with lumbar degenerative conditions including degenerative disk disease, spondylolisthesis with significant back and or leg complaints that have failed greater than 6 weeks of conservative therapy that are felt to be candidates for posterior lumbar instrumented fusion with transforaminal interbody fusion (TLIF).

You may qualify if:

• male or female age 18-75
• candidate for TLIF
• Lumbar levels L1-S1

You may not qualify if:

• 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 & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Ahmad Nassr, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 25, 2009
• Study Start: March 1, 2009
• Primary Completion: April 21, 2016
• Study Completion: April 21, 2016
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

US (1)