At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 280 enrolled
Drug / intervention
PRESTIGE® LP Cervical Disc +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.
A Prospective, Multicenter, Controlled Clinical Trial of an Artificial Cervical Disc LP at a Single Level for Symptomatic Cervical Disc Disease
In Brief
A Phase 3 clinical trial evaluating PRESTIGE® LP Cervical Disc and ATLANTIS Anterior Cervical Plate for Cervical Degenerative Disc Disease. Completed, enrolled 280 participants across 16 sites.
Detailed Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative disc disease at a single level from C3-C4 to C6-C7.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Degenerative Disc Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
Primary CompletionJan 2008
First PostedApr 2008
Study CompletionJun 2014
TodayJul 2026
First PostedApr 28, 2008
Enrollment StartJan 1, 2005
Primary CompletionJan 1, 2008
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 18.2 years ago
Interventions
PRESTIGE® LP Cervical Discdevice
The PRESTIGE® LP Cervical Disc was inserted into the intervertebral disc space of the cervical spine using the anterior surgical approach.
ATLANTIS Anterior Cervical Platedevice
Anterior cervical discectomy and fusion with ATLANTIS plate for control group