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NCT00984672 · ClinicalTrials.gov registry record
Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 103
- Enrollment target
NCT00984672: Completed study, sponsored by Mayo Clinic.
NCT00984672 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 103 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00984672 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 103 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2009-03 |
| Est. Completion | 2016-04-21 |
What the finished NCT00984672 record still lists
NCT00984672 is an observational study that tracks outcomes without assigning an intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00984672 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00984672 about?
NCT00984672 is a clinical study titled "Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery". 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 clinic...
What is the current status of trial NCT00984672?
This trial is currently completed. The enrollment target is 103 participants. The study started on 2009-03. Estimated completion is 2016-04-21.
Who is sponsoring clinical trial NCT00984672?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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