Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
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|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.
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): NCT00437190
Show 38 Study Locations
|Principal Investigator:||Rick C Sasso, MD||Indiana Spine Group|