PRESTIGE® Cervical Disc Study
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|ClinicalTrials.gov Identifier: NCT00642876|
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : August 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Cervical Disc Disease||Device: Allograft Fusion and ATLANTIS™ Cervical Plate System Device: PRESTIGE® Cervical Disc||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||541 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of the PRESTIGE® Cervical Disc Device at a Single Level for Symptomatic Cervical Disc Disease|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||May 2013|
Active Comparator: Control
The Control cohort are patients that receive the fusion treatment.
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.
Other Name: ATLANTIS™
The Investigational cohort are the study patients that received the PRESTIGE® Cervical Disc.
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.
Other Name: PRESTIGE®
- The primary endpoint is overall success, which consists of NDI score, neuro status success, with/without FSU disc ht success, no serious AE classified as "implant/surgical procedure associated", and no secondary surgical procedure classified as failure [ Time Frame: 24 months ]
- The secondary outcomes are radiographic success, medical outcomes SF-36 patient survey (MCS & PCS) success, neck pain status, arm pain status, patient satisfaction, patient global perceived effect, gait assessment, foraminal compression test [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642876
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