NCT00437190

Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF

Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.

Detailed description

Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.

Conditions

• Radiculopathy
• Myelopathy
• Cervical Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	ATLANTIS™ Cervical Plate System and allograft	Control treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System.
DEVICE	BRYAN Cervical Disc Prosthesis	The intent is to treat stable degenerative disc disease by implanting the BRYAN Cervical Disc Prosthesis to provide motion like the normal cervical functional spinal unit.

Timeline

• Start date: 2003-06-01
• Primary completion: 2006-12-01
• Completion: 2016-05-01
• First posted: 2007-02-19
• Last updated: 2016-05-13

Locations

38 sites across 1 country: United States