Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-01 @ 2:43 PM
Study NCT ID:
NCT01832818
Status:
TERMINATED
Last Update Posted:
2019-02-15
First Post:
2013-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
Sponsor:
Pioneer Surgical Technology, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Feasibility, Multi-Center Nonrandomized Clinical Trial Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has been terminated early due to slow enrolment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: