Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

NACompletedINTERVENTIONAL
Enrollment

397

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

January 31, 2011

Study Completion Date

February 1, 2018

Conditions
Cervical Degenerative Disc DiseaseRadiculopathyMyelopathy
Interventions
DEVICE

PRESTIGE LP device at two adjacent levels

PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.

DEVICE

Bi-level fusion with ATLANTIS Cervical Plate System

Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Trial Locations (29)

14203

University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute, Buffalo

14224

Buffalo Neurosurgery Group, West Seneca

15212

Allegheny Neurosurgery; Washington Hospital, Pittsburgh

18104

OAA Orthopaedic Specialists, Allentown

19713

Delaware Neurosurgical Group; Christiana Care Health Systems, Newark

22601

Virginia Brain and Spine; Winchester Medical Center, Winchester

26506

West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc., Morgantown

29169

Lexington Brain and Spine Institute, West Columbia

30342

Peachtree Neurosurgery, Northside Hospital, Atlanta

31908

The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center, Columbus

32405

Spinal Associates, Gulf Coast Hospital, Panama City

35801

The Orthopaedic Center; Crestwood Medical Center, Huntsville

37404

Center for Sports Medicine and Orthopaedics; Memorial Hospital, Chattanooga

37604

East Tennessee Brain & Spine Center, Johnson City Medical Center, Johnson City

43081

Central Ohio Neurological Surgeons; Mt. Carmel East Hospital, Westerville

44333

Crystal Clinic, Inc.; Akron General Medical Center, Akron

46804

Neuro Spine & Pain Center; Lutheran Hospital, Fort Wayne

48322

Henry Ford Hospital, West Bloomfield

48604

Adams Neurosurgery; Mid Michigan Medical Center, Saginaw

49505

Great Lakes Neurosurgical; Spectrum Health East Campus, Grand Rapids

52242

University of Iowa Hospitals & Clinics, Iowa City

59802

Montana Neuro Science Institute; St. Patrick's Medical Center, Missoula

63017

The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital, Chesterfield

78731

Central Texas Spine Institute; Health South Surgical Center, Austin

90210

Todd Lanman, MD, FACS, A Professional Corp.;, Beverly Hills

92037

La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas, La Jolla

92324

Bone & Spine Surgery, Colton

94117

St. Mary's Spine Center; St. Mary's Hospital, San Francisco

97701

The Center Orthopaedic & Neurosurgical Care & Research, Bend

All Listed Sponsors
lead

Medtronic Spinal and Biologics

INDUSTRY

NCT00637156 - Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels | Biotech Hunter | Biotech Hunter