NCT00642876

PRESTIGE® Cervical Disc Study

Investigation of the PRESTIGE® Cervical Disc Device at a Single Level for Symptomatic Cervical Disc Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is to evaluate the safety and effectiveness of the ACD in the single level surgical treatment of patients with symptomatic cervical degenerative disc disease. The primary follow-up information obtained from this clinical investigation are used to support a PMA application for the ACD.

Conditions

• Degenerative Cervical Disc Disease

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2002-10-01
• Primary completion: 2006-07-01
• Completion: 2013-05-01
• First posted: 2008-03-25
• Last updated: 2023-05-10

Locations

31 sites across 1 country: United States