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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: Completed Phase 3 study of Symptomatic Cervical Disc Disease, sponsored by Zimmer Biomet.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (\< 3mm translation; \< 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months
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 |
What the finished NCT00758758 record still lists
NCT00758758 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
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 lists 13 locations in 10 states (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.
Learn More About Clinical Trials
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Where NCT00758758's enrollment target sits among peer trials
231 1300th of 2000 higher than 697 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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