NCT01832818

Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Pioneer Surgical Technology, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cervical Intervertebral Disc Degeneration

Interventions

Type	Name	Description
DEVICE	NuNec Cervical Disc	Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-04-16
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

1 site across 1 country: United Kingdom