NCT00945243

Clinical Outcomes Study Evaluating the Zero-P PEEK

Prospective, Multi-Center Clinical Outcomes Study Evaluating the Zero-P PEEK for Anterior Cervical Interbody Fusion in the Treatment of Cervical Degenerative Disc Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Synthes USA HQ, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, outcomes study. In this study, the Zero-P PEEK implant will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3 and C7. The cohort will be followed over time to twenty-four (24) months after surgery. Up to fifteen (15) sites will participate in this study. This is not a controlled study.

Detailed description

This was a post-market study

Conditions

• Cervical Disc Disease

Interventions

Type	Name	Description
DEVICE	Zero-P	The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-07-24
• Last updated: 2017-11-06
• Results posted: 2017-01-13

Locations

14 sites across 1 country: United States