At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 231 enrolled
Drug / intervention
Anterior Cervical Discectomy and Fusion +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Performance of the Hedrocel(R) Cervical Fusion Device
In Brief
A Phase 3 clinical trial evaluating Anterior Cervical Discectomy and Fusion for Symptomatic Cervical Disc Disease. Completed, enrolled 231 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Cervical Disc Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2001
First PostedSep 2008
Primary CompletionJan 2009
Study CompletionJun 2009
TodayJul 2026
First PostedSep 25, 2008
Enrollment StartDec 1, 2001
Primary CompletionJan 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 17.8 years ago
Interventions
Anterior Cervical Discectomy and Fusiondevice
Implantation of Hedrocel
Anterior Cervical Discectomy and Fusiondevice
Implantation of Allograft
Anterior Cervical Discectomy and Fusiondevice
Implantation of Autograft