MedTrace Logo

Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

NCT00637156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2018-05-01

Study results available
· View outcomes & findings →

Summary

The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.

Conditions

  • Cervical Degenerative Disc Disease
  • Radiculopathy
  • Myelopathy

Interventions

DEVICE

PRESTIGE LP device at two adjacent levels

PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.

DEVICE

Bi-level fusion with ATLANTIS Cervical Plate System

Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Principal Investigators

  • John K Burkus, M.D. · The Hughston Clinic, P.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-01-31
Completion
2018-02-01

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 NCT00637156 on ClinicalTrials.gov