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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00984672
Recruitment Status : Active, not recruiting
First Posted : September 25, 2009
Last Update Posted : April 3, 2020
Information provided by (Responsible Party):
Ahmad Nassr, Mayo Clinic

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.

Condition or disease
Lumbar Degenerative Disease

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
Study Start Date : March 2009
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2020

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00984672

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Ahmad Nassr, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Ahmad Nassr, PI, Mayo Clinic Identifier: NCT00984672    
Other Study ID Numbers: 08-008802
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Keywords provided by Ahmad Nassr, Mayo Clinic:
Lumbar Degenerative Disease
Bone Morphogenetic Protein
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases