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SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

NCT00882661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2017-06-09

Study results available
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Summary

The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion.

The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc

Conditions

  • Symptomatic Cervical Disc Disease

Interventions

DEVICE

SECURE-C Cervical Artificial Disc

Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc

DEVICE

ASSURE Cervical plate and an allograft interbody spacer

Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion

Sponsors & Collaborators

  • Globus Medical Inc

    lead INDUSTRY

Principal Investigators

  • Joseph M Marzluff, MD · Trident Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2010-04-30
Completion
2017-02-28

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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 NCT00882661 on ClinicalTrials.gov