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

NCT01832818 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-02-15

Study results available
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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.

Conditions

  • Cervical Intervertebral Disc Degeneration

Interventions

DEVICE

NuNec Cervical Disc

Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.

Sponsors & Collaborators

  • Pioneer Surgical Technology, Inc.

    lead INDUSTRY

Principal Investigators

  • Tai Friesem, MD · University Hospital of North Tees

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01832818 on ClinicalTrials.gov