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Performance of the Hedrocel(R) Cervical Fusion Device

NCT00758758 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2013-08-23

Study results available
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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

  • Symptomatic Cervical Disc Disease

Interventions

DEVICE

Anterior Cervical Discectomy and Fusion

Implantation of Hedrocel

DEVICE

Anterior Cervical Discectomy and Fusion

Implantation of Allograft

DEVICE

Anterior Cervical Discectomy and Fusion

Implantation of Autograft

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2009-01-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00758758 on ClinicalTrials.gov