Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
|ClinicalTrials.gov Identifier: NCT00437190|
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Radiculopathy Myelopathy Cervical Degenerative Disc Disease||Device: ATLANTIS™ Cervical Plate System and allograft Device: BRYAN Cervical Disc Prosthesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||494 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||May 2016|
|Active Comparator: Anterior Cervical Discectomy Fusion||
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.
Experimental: BRYAN Cervical Disc Prosthesis
BRYAN Cervical Disc Prosthesis is a cervical intervertebral disc prosthesis designed to provide for motion like the normal cervical functional spinal unit.
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.
- Improvement in patient pain and ability to function [ Time Frame: 24 months ]The self-administered Neck Disability Index patient questionnaire is used to assess patient pain and ability to function. A successful outcome will be declared if: Postoperative Score - Postoperative Score is ≥ 15.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437190
Show 38 Study Locations
|Principal Investigator:||Rick C Sasso, MD||Indiana Spine Group|