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COMPLETED Phase 3

MAVERICK™ Total Disc Replacement- Pivotal Study

NCT00635843 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 577 participants
Start Date 2003-04
Est. Completion 2010-11
Phase Phase 3

Sponsor

Medtronic Spinal and Biologics

35 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 577 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Spinal and Biologics, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00635843 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Colorado, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00635843?

This trial is sponsored by Medtronic Spinal and Biologics, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial