Performance of the Hedrocel(R) Cervical Fusion Device

Symptomatic Cervical Disc Disease Clinical Trial

Official title: Performance of the Hedrocel(R) Cervical Fusion Device

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. Success criteria include radiographic evidence of fusion, and improvement in pain, function and overall quality of life. If shown to be successful, the use of the Hedrocel Cervical Fusion Device would eliminate complications associated with harvesting autologous bone graft and provide an alternative for those who are unable to provide autologous bone graft from the iliac crest. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Symptomatic Cervical Disc Disease

• NCT number: NCT00758758
• Study type: Interventional
• Source: Zimmer, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: December 2001
• Completion date: June 2009