Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
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Purpose
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 |
|---|
|
Lumbar Degenerative Disease |
| Study Type: | Observational |
| Study Design: | 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 |
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Contact: Vickie M. Treder, LPN | 507-538-3561 | treder.vickie@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Vickie M. Treder, LPN 507-538-3561 treder.vickie@mayo.edu | |
| Principal Investigator: Ahmad Nassr, M.D. | |
| Principal Investigator: | Ahmad Nassr, M.D. | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Ahmad Nassr, PI, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00984672 History of Changes |
| Other Study ID Numbers: | 08-008802 |
| Study First Received: | September 23, 2009 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Lumbar Degenerative Disease Bone Morphogenetic Protein TLIF |
Additional relevant MeSH terms:
|
Radiculopathy Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013