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COMPLETED Phase 3

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

NCT00215319 · View on ClinicalTrials.gov ↗

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

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00215319

The ClinicalTrials.gov registry entry for NCT00215319 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 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DePuy Spine, which has 3 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 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. 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: NCT00215319 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Alabama, Indiana. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00215319?

The interventions under investigation include: Lumbar I/F with cage and pedicle screws (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00215319?

This trial is sponsored by DePuy Spine, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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