Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
Public ClinicalTrials.gov record NCT00942045. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation. The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph. 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).
Study identification
- NCT ID
- NCT00942045
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 182 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2009
- Primary completion
- Sep 30, 2012
- Completion
- Sep 30, 2012
- Last update posted
- Dec 23, 2025
2009 – 2012
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Shiley Center for Orthopaedic, Scripps Green Hospital | La Jolla | California | 92037 | — |
| Stanford University | Redwood City | California | 94063 | — |
| UCSD Department of Orthpaedic Surgery, UCSD Medical Center | San Diego | California | 92103 | — |
| The Spine Institute, St. John's Health Center | Santa Monica | California | 90404 | — |
| University of South Florida Department of Neurosurgery, Tampa General Hospital | Tampa | Florida | 33606 | — |
| Pinnacle Orthopaedics, Wellstone Kennestone Hospital | Marietta | Georgia | 30060 | — |
| Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center | Joliet | Illinois | 60435 | — |
| Indiana Center for NeuroSurgery, Indiana Surgery Center East | Indianopolis | Indiana | 46219 | — |
| Columbia Orthopaedic Group, Boone Hospital Center | Columbia | Missouri | 65201 | — |
| NWREI (for Ortho Montana) | Billings | Montana | 59101 | — |
| Buffalo Spine Surgery, Kenmore Mercy | Lockport | New York | 14094 | — |
| Duke University Medical Center | Durham | North Carolina | 27708 | — |
| The Center for Advanced Orthopaedics, Adena Bone and Joint Center | Chillicothe | Ohio | 45601 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19106 | — |
| Spine Team Texas, Texas Health Harris Methodist Hospital Southlake | Southlake | Texas | 76092 | — |
| Winchester Medical Center | Winchester | Virginia | 22601 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00942045, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 23, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00942045 live on ClinicalTrials.gov.