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NCT00215319 · ClinicalTrials.gov registry record · Phase 3

Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.

A Phase 3 study of Degenerative Disc Disease, sponsored by DePuy Spine.

Completed
Registry status
Phase 3
Development phase
139
Enrollment target
2
Study locations

NCT00215319 is a Phase 3 study of Degenerative Disc Disease that has completed, run by DePuy Spine. The registered enrollment target is 139 participants, below the 165-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (16% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00215319, a Phase 3 study of Degenerative Disc Disease, has completed, sponsored by DePuy Spine.

COMPLETED
Registry status
Phase 3
Development phase
139 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. The observed success rate at 24 months will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.

Conditions Studied

Interventions

  • DEVICE Lumbar I/F with cage and pedicle screws

Study Locations (2)

Alabama

  • TSM Investigational Site A - Dothan

Indiana

  • TSM Investigational Site B - Fort Wayne

Trial Details

FieldValue
Enrollment Target 139 participants
Start Date 2000-12
Est. Completion 2006-11
Phase Phase 3

Sponsor

DePuy Spine

5 total trials

What the Registry Record Tells You About NCT00215319

The ClinicalTrials.gov registry entry for NCT00215319 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 165-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (16% lower). The listed sponsor is DePuy Spine, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Degenerative Disc Disease appearing as the primary indexed condition, and to 1 intervention - of which Lumbar I/F with cage and pedicle screws is the first listed.

NCT00215319 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Alabama, Indiana.

Frequently Asked Questions

What is clinical trial NCT00215319 about?

NCT00215319 is a clinical study titled "Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.". The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. The observed success rate at 24 months will be compared t...

What is the current status of trial NCT00215319?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2000-12. Estimated completion is 2006-11.

What conditions does trial NCT00215319 study?

This clinical trial studies the following conditions: Degenerative Disc Disease.

What interventions are being tested in trial NCT00215319?

The interventions under investigation include: Lumbar I/F with cage and pedicle screws (DEVICE).

Who is sponsoring clinical trial NCT00215319?

This trial is sponsored by DePuy Spine, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00215319 being conducted?

This trial has 2 study locations across Alabama, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.