Performance of the Hedrocel(R) Cervical Fusion Device
Public ClinicalTrials.gov record NCT00758758. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving autologous iliac crest bone graft or allograft and test the hypothesis that ACDF with Hedrocel is non-inferior to ACDF with allograft or autologous bone graft.
Study identification
- NCT ID
- NCT00758758
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 231 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
- Dec 2001 (Type not available)
- Primary completion
- Jan 2009 (Actual)
- Completion
- Jun 2009 (Actual)
- Last update posted
- Aug 23, 2013
2001 – 2009
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center Institute for Spinal Disorders | Los Angeles | California | 90048 | — |
| Orthopaedic Specialties | Clearwater | Florida | 33756 | — |
| Southeastern Clinic Research | Orlando | Florida | 32804 | — |
| Fort Wayne Orthopedics | Fort Wayne | Indiana | 46804 | — |
| Spine Surgery PSC | Louisville | Kentucky | 40202 | — |
| Four East Madison Orthopaedic Associates, PA | Baltimore | Maryland | 21204 | — |
| Boston Spine Group, LLC | Boston | Massachusetts | 02120 | — |
| Twin Cities Spine Center | Minneapolis | Minnesota | 55404 | — |
| Orthocarolina | Charlotte | North Carolina | 28207 | — |
| Howell Allen Clinic | Nashville | Tennessee | 37203 | — |
| Vanderbilt Orthopedic Institute | Nashville | Tennessee | 37232-8774 | — |
| University of Virginia Health System - Department of Neurosurgery | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax Hospital | Fairfax | Virginia | 22031 | — |
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 NCT00758758, 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 Aug 23, 2013 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00758758 live on ClinicalTrials.gov.