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NCT00948532 · ClinicalTrials.gov registry record
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
A clinical trial, sponsored by NuVasive.
- Completed
- Registry status
- 104
- Enrollment target
NCT00948532 is a clinical trial that has completed, run by NuVasive. The registered enrollment target is 104 participants.
The verdict
NCT00948532 has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- 104 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 XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their XLIF operation. 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 | 104 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00948532
The ClinicalTrials.gov registry entry for NCT00948532 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 104 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.
NCT00948532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00948532 about?
NCT00948532 is a clinical study titled "Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)". This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical trea...
What is the current status of trial NCT00948532?
This trial is currently completed. The enrollment target is 104 participants. The study started on 2009-03. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00948532?
The interventions under investigation include: biologic, Osteocel Plus (BIOLOGICAL).
Who is sponsoring clinical trial NCT00948532?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
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