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

NACompletedINTERVENTIONAL
Enrollment

494

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

December 31, 2006

Study Completion Date

May 31, 2016

Conditions
RadiculopathyMyelopathyCervical Degenerative Disc Disease
Interventions
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.

Trial Locations (38)

13029

Upstate Orthopedics, Syracuse

13210

Crouse Hospital, Syracuse

14623

Rochester Brain and Spine Neuro, Rochester

15212

Allegheny General Hospital, Pittsburgh

21401

Maryland Brain & Spine, Annapolis

27157

Wake Forest University School of Medicine - Dept. of Neurosurgery Medical Center, Winston-Salem

28204

Carolina Neurosurgery and Spine Specialists, Charlotte

29464

Southeastern Spine Institute, Mt. Pleasant

30329

Emory Orthopedics and Spine Center, Atlanta

32308

Tallahassee Neurological Clinic, Tallahassee

32605

North Florida Regional Medical Center, Gainesville

33136

University of Miami School of Medicine, Miami

37203

Neurosurgical Associates, Nashville

43608

Neurosurgical Network, Inc., Toledo

46202

Indiana University School of Medicine, Indianapolis

46260

Indiana Spine Group, Indianapolis

49048

Neurosurgery of Kalamazoo, Kalamazoo

49855

Marquette General Brain & Spine Center, Marquette

53792

University of Wisconsin Medical School, Madison

55404

Twin Cities Spine Center, Minneapolis

55439

Cervical Spine Specialists, Edina

60611

Northwestern University Department of Neurosurgery, Chicago

60637

University of Chicago Hospitals Section of Neurosurgery, Chicago

60640

Chicago Inst. of Neurosurgery and Neuro Research, Chicago

63110

Washington University Orthopedics, St Louis

65201

Columbia Orthopaedic Group, Columbia

72205

University of Arkansas for Medical Sciences, Little Rock

75093

NeuroSpine Consultants, PA, Plano

84103

Neurosurgery Associates, Salt Lake City

85013

Barrow Neurosurgical Associates, Phoenix

89502

Spine Nevada, Reno

90048

Cedars Sinai Medical Center, Los Angeles

92663

Hoag Memorial Hospital, Newport Beach

94598

Bay Area Spine Institute, Walnut Creek

95008

Silicon Valley Spine Institute, Campbell

97086

Kellogg MD Brain & Spine, Portland

97477

Oregon Neurosurgery, Springfield

04074

Neurosurgery Associates, Scarborough

All Listed Sponsors
lead

Medtronic Spinal and Biologics

INDUSTRY

NCT00437190 - Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF | Biotech Hunter | Biotech Hunter