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NCT00942045 · ClinicalTrials.gov registry record
Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
A clinical trial, sponsored by NuVasive.
- Completed
- Registry status
- 182
- Enrollment target
NCT00942045 is a clinical trial that has completed, run by NuVasive. The registered enrollment target is 182 participants.
The verdict
NCT00942045 has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- 182 participants
- Enrollment target
Study Summary
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation. The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).
Interventions
- BIOLOGICAL Biologic - Osteocel Plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00942045
The ClinicalTrials.gov registry entry for NCT00942045 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NuVasive, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Biologic - Osteocel Plus is the first listed.
NCT00942045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00942045 about?
NCT00942045 is a clinical study titled "Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)". This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to...
What is the current status of trial NCT00942045?
This trial is currently completed. The enrollment target is 182 participants. The study started on 2009-02. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00942045?
The interventions under investigation include: Biologic - Osteocel Plus (BIOLOGICAL).
Who is sponsoring clinical trial NCT00942045?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
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