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Investigation of the Simplify® Cervical Artificial Disc

NCT02667067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-08

Study results available
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Summary

This study is intended to demonstrate that the Simplify® Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat one level between C3 to C7 for cervical degenerative disc disease (DDD) defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain or myelopathy due to a single-level abnormality localized to the level of the disc space in subjects who are unresponsive to conservative management.

Conditions

  • Cervical Degenerative Disc Disease

Interventions

DEVICE

Simplify Disc

Simplify Disc at one level in the cervical spine.

DEVICE

Anterior Cervical Discectomy & Fusion

This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®\|C Disc trial.

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Principal Investigators

  • Kyle Malone · NuVasive

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-03-23
Completion
2021-07-29

Countries

  • United States

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 NCT02667067 on ClinicalTrials.gov