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COMPLETED

Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)

NCT00948831 · View on ClinicalTrials.gov ↗

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

Sponsor

NuVasive

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00948831

The ClinicalTrials.gov registry entry for NCT00948831 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NuVasive, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00948831 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Indiana, California, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00948831?

The interventions under investigation include: Osteocel Plus (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00948831?

This trial is sponsored by NuVasive, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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