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NCT00635843 · ClinicalTrials.gov registry record · Phase 3
MAVERICK™ Total Disc Replacement- Pivotal Study
A Phase 3 study of Spinal Diseases, sponsored by Medtronic Spinal and Biologics.
- Completed
- Registry status
- Phase 3
- Development phase
- 577
- Enrollment target
- 20
- Study locations
NCT00635843 is a Phase 3 study of Spinal Diseases that has completed, run by Medtronic Spinal and Biologics. The registered enrollment target is 577 participants, below the 43,553-participant average among 4 other Spinal Diseases trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT00635843, a Phase 3 study of Spinal Diseases, has completed, sponsored by Medtronic Spinal and Biologics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 577 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE MAVERICK™ Disc
- DEVICE LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft
Study Locations (20)
California
- Spine Care Medical Group - Daly City
- Little Company of Mary Hospital - Los Angeles
- Newport Orthopedic Institute - Newport Beach
- Orthopaedic Specialty Institute - Orange
Colorado
- Boulder Neurosurgical Associates - Boulder
- Rocky Mountain Associates in Orthopaedic Medicine - Loveland
Illinois
- Northwestern Orthopedic Institute - Chicago
- Illinois Bone and Joint Institute - Morton Grove
Indiana
- Fort Wayne Orthopaedics - Fort Wayne
- Orthopedics of Indianapolis - Indianapolis
Alabama
- The Spine Center at TOC - Huntsville
Connecticut
- Orthopaedic & Sports Medicine Center - Trumbull
Delaware
- First State Orthopaedics, P.A. - Newark
District of Columbia
- Walter Reed Army Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 577 participants |
| Start Date | 2003-04 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00635843
The ClinicalTrials.gov registry entry for NCT00635843 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 577 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 43,553-participant average among 4 other Spinal Diseases trials with a reported enrollment target (99% lower). The listed sponsor is Medtronic Spinal and Biologics, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Diseases appearing as the primary indexed condition, and to 2 interventions - of which MAVERICK™ Disc is the first listed.
NCT00635843 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Colorado, Illinois.
Frequently Asked Questions
What is clinical trial NCT00635843 about?
NCT00635843 is a clinical study titled "MAVERICK™ Total Disc Replacement- Pivotal Study". 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 obje...
What is the current status of trial NCT00635843?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 577 participants. The study started on 2003-04. Estimated completion is 2010-11.
What conditions does trial NCT00635843 study?
This clinical trial studies the following conditions: Spinal Diseases.
What interventions are being tested in trial NCT00635843?
The interventions under investigation include: MAVERICK™ Disc (DEVICE), LT-CAGE® Lumbar Tapered Fusion Device and INFUSE® Bone Graft (DEVICE).
Who is sponsoring clinical trial NCT00635843?
This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00635843 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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