Completed

A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

What is being tested

SECURE-C Cervical Artificial Disc

+ ASSURE Cervical plate and an allograft interbody spacer

Device

Who is being recruted

Neurologic Manifestations+2

+ Pain

+ Signs and Symptoms

From 18 to 60 Years

+38 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: July 2005

See protocol details

Summary

Principal SponsorGlobus Medical Inc

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2005

Actual date on which the first participant was enrolled.

Ages Eligible for Study: 18 to 60 years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Official TitleA Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

NCT00882661

Principal SponsorGlobus Medical Inc

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

380 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsNeck Pain

Criteria

12 inclusion criteria required to participate

Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:

Herniated nucleus pulposus;

Radiculopathy or myelopathy;

Spondylosis (defined by the presence of osteophytes); or

Show More Criteria

26 exclusion criteria prevent from participating

More than one vertebral level requiring treatment

Prior fusion surgery adjacent to the vertebral level being treated

Prior surgery at the level to be treated

Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers