NCT01511445

Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome

Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome; a Blinded Randomised Trial of Cancellous Structured Ceramic (CSC) Versus PEEK Cages.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Amedica Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study randomizes neck and arm pain patients being treated with discectomy and anterior interbody fusion into two groups: one to receive a new ceramic implant and a control group with a more traditional plastic implant. The study will measure and compare pain and disability improvement with the two products over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.

Conditions

• Radiating Pain
• Myelopathy
• Cervicobrachial Syndrome

Interventions

Type	Name	Description
DEVICE	Anterior cervical discectomy and fusion (ACDF) with PEEK Cage	Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
DEVICE	Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage	Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-10-01
• Completion: 2015-11-01
• First posted: 2012-01-18
• Last updated: 2017-05-08
• Results posted: 2017-05-08

Locations

1 site across 1 country: Netherlands