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.

Study IDs

  • Site IRB:

    • 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.

Participation eligibility

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. 

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ahmad Nassr, M.D.

Closed for enrollment

Barry Birch M.D.

(480)301-5777

Birch.Barry@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Ahmad Nassr, M.D.

Closed for enrollment

Vickie Treder CCRP

(507)538-3561

Treder.Vickie@mayo.edu