MedTrace Logo

Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF

NCT00437190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2016-05-13

No results posted yet for this study

Summary

The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.

Conditions

  • Radiculopathy
  • Myelopathy
  • Cervical Degenerative Disc Disease

Interventions

DEVICE

ATLANTIS™ Cervical Plate System and allograft

Control treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System.

DEVICE

BRYAN Cervical Disc Prosthesis

The intent is to treat stable degenerative disc disease by implanting the BRYAN Cervical Disc Prosthesis to provide motion like the normal cervical functional spinal unit.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Principal Investigators

  • Rick C Sasso, MD · Indiana Spine Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2006-12-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00437190 on ClinicalTrials.gov