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PRESTIGE® Cervical Disc Study

NCT00642876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2023-05-10

No results posted yet for this study

Summary

The purpose of this clinical investigation is to evaluate the safety and effectiveness of the ACD in the single level surgical treatment of patients with symptomatic cervical degenerative disc disease. The primary follow-up information obtained from this clinical investigation are used to support a PMA application for the ACD.

Conditions

  • Degenerative Cervical Disc Disease

Interventions

DEVICE

Allograft Fusion and ATLANTIS™ Cervical Plate System

The patients that received the control treatment underwent a single level anterior cervical fusion procedure involving allograft bone and the ATLANTIS™ Cervical Plate System.

DEVICE

PRESTIGE® Cervical Disc

The PRESTIGE® Cervical Disc is a stainless steel device that was inserted into the intervertebral disc space. The device is composed of two metal plates that interface via a ball and socket mechanism permitting segmental spinal motion.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-07-31
Completion
2013-05-31

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 NCT00642876 on ClinicalTrials.gov