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Clinical Trial Summary

The objective of this study is to evaluate long-term safety and effectiveness of the NuNec® Cervical Arthroplasty System in a small patient population. The NuNec device is currently CE marked and commercially available in Europe.


Clinical Trial Description

The NuNec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. Only patients who have been diagnosed with single level, C3 to C7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled.

Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01832818
Study type Interventional
Source Pioneer Surgical Technology, Inc.
Contact
Status Terminated
Phase N/A
Start date March 2012
Completion date January 2016

See also
  Status Clinical Trial Phase
Completed NCT00215293 - Cervical I/F Cage for Anterior Cervical Fusion Phase 3