Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Spinal Diseases, sponsored by Medtronic Spinal and Biologics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A patient will be considered an overall success if all of the following conditions are met: 1. pain/disability(Oswestry)success; 2. neurological status success; 3. disc height success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure".
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 |
What the finished NCT00635843 record still lists
NCT00635843 is an interventional study that assigns participants to a tested intervention. The registered 577 participants enrollment target is mid-sized for trials with a published cap, below the 43,553-participant average among 4 other Spinal Diseases trials with a reported enrollment target (99% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Spinal Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07290543 · 578 participants · NA
Web-Based Toolkit to Improve Cancer-Related Emotional Distress and Anxiety in Rural Older Cancer Survivors
- NCT04931810 · 576 participants · NA
Urban and Reservation Implementation of All Nations Breath of Life
- NCT05179369 · 576 participants · NA
Well-Mama Community Doula Navigator Study
- NCT06398509 · 576 participants · NA
A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia