MAVERICK™ Total Disc Replacement- Pivotal Study
Public ClinicalTrials.gov record NCT00635843. 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 Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, 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 be examined.
Study identification
- NCT ID
- NCT00635843
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 577 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- 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
- Apr 2003 (Type not available)
- Primary completion
- Oct 2006 (Actual)
- Completion
- Nov 2010 (Actual)
- Last update posted
- Aug 2, 2013
2003 – 2010
United States locations
- U.S. sites
- 32
- U.S. states
- 23
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Spine Center at TOC | Huntsville | Alabama | 35801 | — |
| Spine Care Medical Group | Daly City | California | 94015 | — |
| Little Company of Mary Hospital | Los Angeles | California | 90045 | — |
| Newport Orthopedic Institute | Newport Beach | California | 92660 | — |
| Orthopaedic Specialty Institute | Orange | California | 92868 | — |
| Boulder Neurosurgical Associates | Boulder | Colorado | 80304 | — |
| Rocky Mountain Associates in Orthopaedic Medicine | Loveland | Colorado | 80538 | — |
| Orthopaedic & Sports Medicine Center | Trumbull | Connecticut | 06611 | — |
| First State Orthopaedics, P.A. | Newark | Delaware | 19713 | — |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | — |
| The B.A.C.K. Center | Melbourne | Florida | 32901-1937 | — |
| Hughston Clinic | Columbus | Georgia | 31908 | — |
| Spine Institute of Idaho | Meridian | Idaho | 83642 | — |
| Northwestern Orthopedic Institute | Chicago | Illinois | 60611 | — |
| Illinois Bone and Joint Institute | Morton Grove | Illinois | 60053 | — |
| Fort Wayne Orthopaedics | Fort Wayne | Indiana | 46804 | — |
| Orthopedics of Indianapolis | Indianapolis | Indiana | 46278 | — |
| Institute for Low Back & Neck Care | Minneapolis | Minnesota | 55407 | — |
| Orthopedic Center of St. Louis | Chesterfield | Missouri | 63017 | — |
| Nebraska Spine Center, LLC | Omaha | Nebraska | 68154-4428 | — |
| New Hampshire Spine Institute | Bedford | New Hampshire | 03110-4201 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Spine Carolina | Asheville | North Carolina | 28803 | — |
| Oklahoma Sports Science & Ortho | Oklahoma City | Oklahoma | 73139 | — |
| Southeastern Spine Institute | Mt. Pleasant | South Carolina | 29464 | — |
| Central Texas Spine | Austin | Texas | 78731 | — |
| The Center for Spine Care | Dallas | Texas | 75231 | — |
| Advanced Neurosurgical Center | El Paso | Texas | 79902 | — |
| Virginia Spine Institute | Reston | Virginia | 20190 | — |
| Neurosurgical Associates, PC | Richmond | Virginia | 23229 | — |
| Inland Neurosurgery and Spine Associates, PS | Spokane | Washington | 99204 | — |
| University of Wisconsin Orthopedic Department | Madison | Wisconsin | 53792-7375 | — |
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 NCT00635843, 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 Aug 2, 2013 · 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 NCT00635843 live on ClinicalTrials.gov.