Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
Public ClinicalTrials.gov record NCT00637156. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00637156
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 397 participants
Conditions and interventions
Interventions
- PRESTIGE LP device at two adjacent levels Device
- Bi-level fusion with ATLANTIS Cervical Plate System Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2006 (Type not available)
- Primary completion
- Jan 2011 (Actual)
- Completion
- Feb 1, 2018 (Actual)
- Last update posted
- May 1, 2018
2006 – 2018
United States locations
- U.S. sites
- 29
- U.S. states
- 19
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Orthopaedic Center; Crestwood Medical Center | Huntsville | Alabama | 35801 | — |
| Todd Lanman, MD, FACS, A Professional Corp.; | Beverly Hills | California | 90210 | — |
| Bone & Spine Surgery | Colton | California | 92324 | — |
| La Jolla Neurological Associates, AMC; Scripps Memorial Hospital La Jolla; Scripps Memorial Hospital Encinitas | La Jolla | California | 92037 | — |
| St. Mary's Spine Center; St. Mary's Hospital | San Francisco | California | 94117 | — |
| Delaware Neurosurgical Group; Christiana Care Health Systems | Newark | Delaware | 19713 | — |
| Spinal Associates, Gulf Coast Hospital | Panama City | Florida | 32405 | — |
| Peachtree Neurosurgery, Northside Hospital | Atlanta | Georgia | 30342 | — |
| The Hughston Clinic, P.C., Hughston Hospital and Rehabilitation Center | Columbus | Georgia | 31908 | — |
| Neuro Spine & Pain Center; Lutheran Hospital | Fort Wayne | Indiana | 46804 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Great Lakes Neurosurgical; Spectrum Health East Campus | Grand Rapids | Michigan | 49505 | — |
| Adams Neurosurgery; Mid Michigan Medical Center | Saginaw | Michigan | 48604 | — |
| Henry Ford Hospital | West Bloomfield | Michigan | 48322 | — |
| The Orthopedic Center of St. Louis; Barnes Jewish West County Hospital | Chesterfield | Missouri | 63017 | — |
| Montana Neuro Science Institute; St. Patrick's Medical Center | Missoula | Montana | 59802 | — |
| University at Buffalo Neurosurgery, Inc. Kaleida Health-Buffalo General Medical center/Gates Vascular Institute | Buffalo | New York | 14203 | — |
| Buffalo Neurosurgery Group | West Seneca | New York | 14224 | — |
| Crystal Clinic, Inc.; Akron General Medical Center | Akron | Ohio | 44333 | — |
| Central Ohio Neurological Surgeons; Mt. Carmel East Hospital | Westerville | Ohio | 43081 | — |
| The Center Orthopaedic & Neurosurgical Care & Research | Bend | Oregon | 97701 | — |
| OAA Orthopaedic Specialists | Allentown | Pennsylvania | 18104 | — |
| Allegheny Neurosurgery; Washington Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Lexington Brain and Spine Institute | West Columbia | South Carolina | 29169 | — |
| Center for Sports Medicine and Orthopaedics; Memorial Hospital | Chattanooga | Tennessee | 37404 | — |
| East Tennessee Brain & Spine Center, Johnson City Medical Center | Johnson City | Tennessee | 37604 | — |
| Central Texas Spine Institute; Health South Surgical Center | Austin | Texas | 78731 | — |
| Virginia Brain and Spine; Winchester Medical Center | Winchester | Virginia | 22601 | — |
| West Virginia University; Ruby Memorial Hospital, WVU Hospitals, Inc. | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00637156, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 1, 2018 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00637156 live on ClinicalTrials.gov.