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NCT00948831 · ClinicalTrials.gov registry record

Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)

A clinical trial of Degenerative Disc Disease Lumbar, sponsored by NuVasive.

Completed
Registry status
51
Enrollment target
7
Study locations

NCT00948831: Completed study of Degenerative Disc Disease Lumbar, sponsored by NuVasive.

NCT00948831 is a study of Degenerative Disc Disease Lumbar that has completed, run by NuVasive. The registered enrollment target is 51 participants. The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00948831, a study of Degenerative Disc Disease Lumbar, has completed, sponsored by NuVasive.

COMPLETED
Registry status
51 participants
Enrollment target
7
Study locations

Study Summary

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.

Interventions

  • BIOLOGICAL Osteocel Plus

Study Locations (7)

Indiana

  • OrthoIndy, Indiana Orthopedic Hospital - Indianapolis
  • Indiana Spine Group, St. Joseph's Hospital - Kokomo

California

  • University of California at San Francisco - San Francisco

Minnesota

  • Twin Cities Orthopaedics, University of Minnesota Medical Center - Edina

Montana

  • Ortho Montana - Billings

Ohio

  • Cleveland Clinic - Cleveland

Texas

  • Central Texas Spine Institute, Northwest Hills Surgical Hospital - Austin

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2009-04
Est. Completion 2012-10
NuVasive

28 total trials

What the finished NCT00948831 record still lists

NCT00948831 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.

The record links to 1 condition, with Degenerative Disc Disease Lumbar appearing as the primary indexed condition, and to 1 intervention - of which Osteocel Plus is the first listed.

NCT00948831 lists 7 locations in 6 states (Indiana, California, Minnesota).

Frequently Asked Questions

What is clinical trial NCT00948831 about?

NCT00948831 is a clinical study titled "Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)". This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix...

What is the current status of trial NCT00948831?

This trial is currently completed. The enrollment target is 51 participants. The study started on 2009-04. Estimated completion is 2012-10.

What conditions does trial NCT00948831 study?

This clinical trial studies the following conditions: Degenerative Disc Disease Lumbar.

What interventions are being tested in trial NCT00948831?

The interventions under investigation include: Osteocel Plus (BIOLOGICAL).

Who is sponsoring clinical trial NCT00948831?

This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00948831 being conducted?

This trial has 7 study locations across California, Indiana, Minnesota, Montana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00948831, the US trial registry maintained by the National Library of Medicine. NCT00948831 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.