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

May 22, 2014 updated by: DePuy Spine

A Multi-center Study to Evaluate the Safety and Efficacy of DePuy AcroMed Titanium Surgical Mesh and MOSS-Miami Spinal Fixation System Pedicle Screws for Intradiscal Fusion in the Lumbar Spine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single arm multi-center study to determine the clinical success of the DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two adjacent levels of degenerative disc disease of the lumbar spine (L2 - S1).

Study Success is as a compound endpoint requiring:

  • Radiographic Fusion,
  • Improvement in Pain/Function,
  • Maintenance/Improvement in Neurologic Status, and
  • Freedom from Secondary Surgical Intervention.
  • The rate of Adverse Events must be no worse than in the control group as well.

Secondary Endpoints Include:

  • Adverse Events
  • SF-36 Health Related Quality of Life
  • Disc Space Height
  • Work Status

Comparison:

Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • TSM Investigational Site A
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • TSM Investigational Site B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
  • Radiographic evidence of significant disc degeneration at one or two of the adjacent lumbar levels L2-S1.

Exclusion Criteria:

  • Abnormality at more than two levels,
  • Prior fusion surgery of the lumbar spine; prior discectomies or IDET allowed,
  • Infection in the disc or spine, past or present,
  • Active infection at time of surgery,
  • Tumor in the spine,
  • Significant osteoporosis or metabolic bone disease,
  • Greater than Grade I spondylolisthesis or significant bony defect in the lumbar spine,
  • Pregnant or lactating, or wishes to become pregnant within duration of study,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TSM Cage
Lumbar I/F with cage and pedicle screws
Device: Lumbar I/F with cage and pedicle screws
Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse Events
Motor Function
Secondary Surgical Interventions
Radiographic Fusion
Oswestry Disability Index

Secondary Outcome Measures

Outcome Measure
SF-36
Graft site pain
Back pain
Leg pain
Disc space height

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Spine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G990313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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