NCT00758758

Performance of the Hedrocel(R) Cervical Fusion Device

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Symptomatic Cervical Disc Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-12-01
• Primary completion: 2009-01-01
• Completion: 2009-06-01
• First posted: 2008-09-25
• Last updated: 2013-08-23
• Results posted: 2013-08-12

Locations

13 sites across 1 country: United States