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NCT00758758 · ClinicalTrials.gov registry record · Phase 3
Performance of the Hedrocel(R) Cervical Fusion Device
A Phase 3 study of Symptomatic Cervical Disc Disease, sponsored by Zimmer Biomet.
- Completed
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
- 13
- Study locations
NCT00758758 is a Phase 3 study of Symptomatic Cervical Disc Disease that has completed, run by Zimmer Biomet. The registered enrollment target is 231 participants. The trial reports 13 study locations across 10 states.
The verdict
NCT00758758, a Phase 3 study of Symptomatic Cervical Disc Disease, has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
- 13
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Anterior Cervical Discectomy and Fusion
Study Locations (13)
Florida
- Orthopaedic Specialties - Clearwater
- Southeastern Clinic Research - Orlando
Tennessee
- Howell Allen Clinic - Nashville
- Vanderbilt Orthopedic Institute - Nashville
Virginia
- University of Virginia Health System - Department of Neurosurgery - Charlottesville
- Inova Fairfax Hospital - Fairfax
California
- Cedars-Sinai Medical Center Institute for Spinal Disorders - Los Angeles
Indiana
- Fort Wayne Orthopedics - Fort Wayne
Kentucky
- Spine Surgery PSC - Louisville
Maryland
- Four East Madison Orthopaedic Associates, PA - Baltimore
Massachusetts
- Boston Spine Group, LLC - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2001-12 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00758758
The ClinicalTrials.gov registry entry for NCT00758758 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zimmer Biomet, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Symptomatic Cervical Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which Anterior Cervical Discectomy and Fusion is the first listed.
NCT00758758 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Florida, Tennessee, Virginia.
Frequently Asked Questions
What is clinical trial NCT00758758 about?
NCT00758758 is a clinical study titled "Performance of the Hedrocel(R) Cervical Fusion Device". 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 tha...
What is the current status of trial NCT00758758?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2001-12. Estimated completion is 2009-06.
What conditions does trial NCT00758758 study?
This clinical trial studies the following conditions: Symptomatic Cervical Disc Disease.
What interventions are being tested in trial NCT00758758?
The interventions under investigation include: Anterior Cervical Discectomy and Fusion (DEVICE).
Who is sponsoring clinical trial NCT00758758?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00758758 being conducted?
This trial has 13 study locations across California, Florida, Indiana, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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