Clinical trialNCT00637156CompletedInterventional

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

SponsorMedtronic Spinal and BiologicsEnrollment397Cervical Degenerative Disc DiseaseMyelopathyRadiculopathy

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical spine, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will also be examined as the secondary objective.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

John K Burkus, M.D.
The Hughston Clinic, P.C.
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

29 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

the Orthopaedic Center; Crestwood Medical Center
Huntsville, Alabama, United States
Todd Lanman, Md, Facs, A Professional Corp.;
Beverly Hills, California, United States
Bone & Spine Surgery
Colton, California, United States
la Jolla Neurological Associates, Amc; Scripps Memorial Hospital la Jolla; Scripps Memorial Hospital Encinitas
La Jolla, California, United States
St. Mary'S Spine Center; St. Mary'S Hospital
San Francisco, California, United States
Delaware Neurosurgical Group; Christiana Care Health Systems
Newark, Delaware, United States
Spinal Associates, Gulf Coast Hospital
Panama City, Florida, United States
Peachtree Neurosurgery, Northside Hospital
Atlanta, Georgia, United States
the Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center
Columbus, Georgia, United States
Neuro Spine & Pain Center; Lutheran Hospital
Fort Wayne, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Great Lakes Neurosurgical; Spectrum Health East Campus
Grand Rapids, Michigan, United States
Adams Neurosurgery; Mid Michigan Medical Center
Saginaw, Michigan, United States
Henry Ford Hospital
West Bloomfield, Michigan, United States
the Orthopedic Center of St. Louis; Barnes Jewish West County Hospital
Chesterfield, Missouri, United States
Montana Neuro Science Institute; St. Patrick'S Medical Center
Missoula, Montana, United States
University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical Center/gates Vascular Institute
Buffalo, New York, United States
Buffalo Neurosurgery Group
West Seneca, New York, United States
Crystal Clinic, Inc.; Akron General Medical Center
Akron, Ohio, United States
Central Ohio Neurological Surgeons; Mt. Carmel East Hospital
Westerville, Ohio, United States
the Center Orthopaedic & Neurosurgical Care & Research
Bend, Oregon, United States
Oaa Orthopaedic Specialists
Allentown, Pennsylvania, United States
Allegheny Neurosurgery; Washington Hospital
Pittsburgh, Pennsylvania, United States
Lexington Brain and Spine Institute
West Columbia, South Carolina, United States
Center for Sports Medicine and Orthopaedics; Memorial Hospital
Chattanooga, Tennessee, United States
East Tennessee Brain & Spine Center, Johnson City Medical Center
Johnson City, Tennessee, United States
Central Texas Spine Institute; Health South Surgical Center
Austin, Texas, United States
Virginia Brain and Spine; Winchester Medical Center
Winchester, Virginia, United States
West Virginia University; Ruby Memorial Hospital, Wvu Hospitals, Inc.
Morgantown, West Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2006
Primary completion: 31 Jan 2011
Completion: 1 Feb 2018
Last update posted: 1 May 2018
Registered enrollment: 397
Registry id: NCT00637156

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.