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INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial
NCT00485173 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disease.
Conditions Studied
Interventions
- DEVICE INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
Study Locations (16)
California
- S & B Surgery Center — Beverly Hills
- Orange County Neurological Association — Laguna Hills
Ohio
- University of Cincinnati Dept of Neurosurgery — Cincinnati
- TriState Orthopedic Treatment Center — Norwood
Tennessee
- Center for Sports Medcine & Orthopedics — Chattanooga
- Semmes Murphey Neurologic & Spine Institute — Memphis
Texas
- Central Texas Spine — Austin
- Brain and Spine Center of Texas, L.L.P. — Plano
Florida
- Crane Creek Medical Ctr. The Back Center /Osler Medical — Melbourne
Georgia
- The Hughston Clinic, P.C. — Columbus
Kansas
- University of Kansas Medcal Center — Kansas City
Louisiana
- Spine Institute — Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2007-06 |
| Est. Completion | 2012-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00485173
The ClinicalTrials.gov registry entry for NCT00485173 describes a study currently listed as completed. It is categorized as NA, 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 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Spinal and Biologics, which has 35 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 appearing as the primary indexed condition, and to 1 intervention — of which INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate 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: NCT00485173 reports 16 study locations spanning 12 distinct geographic areas — top geographies include California, Ohio, Tennessee. 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 NCT00485173 about?
NCT00485173 is a clinical study titled "INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial". The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level from C3-C7 in patients with symptomatic cervical degenerative disc disea...
What is the current status of trial NCT00485173?
This trial is currently completed. It is a NA study. The enrollment target is 224 participants. The study started on 2007-06. Estimated completion is 2012-06.
What conditions does trial NCT00485173 study?
This clinical trial studies the following conditions: Degenerative Disc Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00485173?
The interventions under investigation include: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00485173?
This trial is sponsored by Medtronic Spinal and Biologics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00485173 being conducted?
This trial has 16 study locations across California, Florida, Georgia, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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