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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.

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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

FieldValue
Enrollment Target 104 participants
Start Date 2009-03
Est. Completion 2012-10

Sponsor

NuVasive

28 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.