CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 397 enrolled
Drug / intervention
PRESTIGE LP device at two adjacent levels +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00637156
NCT00637156N/ACompleted
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A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease

Medtronic Spinal and Biologics·interventional·Posted Mar 17, 2008·Updated May 1, 2018

In Brief

A clinical study evaluating PRESTIGE LP device at two adjacent levels and Bi-level fusion with ATLANTIS Cervical Plate System for Cervical Degenerative Disc Disease and 2 related conditions. Completed, enrolled 397 participants across 29 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Degenerative Disc Disease, Radiculopathy, Myelopathy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2008
Enrollment StartJun 1, 2006
Primary CompletionJan 1, 2011
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 18.3 years ago

Interventions

PRESTIGE LP device at two adjacent levelsdevice

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.

Bi-level fusion with ATLANTIS Cervical Plate Systemdevice

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