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COMPLETED Phase 3

Performance of the Hedrocel(R) Cervical Fusion Device

NCT00758758 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 231 participants
Start Date 2001-12
Est. Completion 2009-06
Phase Phase 3

Sponsor

Zimmer Biomet

102 total trials

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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. It is categorized as Phase 3, 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 231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zimmer Biomet, which has 102 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 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. 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: NCT00758758 reports 13 study locations spanning 10 distinct geographic areas — top geographies include Florida, Tennessee, Virginia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00758758?

The interventions under investigation include: Anterior Cervical Discectomy and Fusion (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00758758?

This trial is sponsored by Zimmer Biomet, which has 102 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial