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

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lumbar I/F with cage and pedicle screws
Sponsored by
DePuy Spine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative disc disease at up to 2 levels (L2-S1)

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • TSM Investigational Site A
  • TSM Investigational Site B

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TSM Cage

Arm Description

Lumbar I/F with cage and pedicle screws

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
May 22, 2014
Sponsor
DePuy Spine
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1. Study Identification

Unique Protocol Identification Number
NCT00215319
Brief Title
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Spine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
Degenerative disc disease at up to 2 levels (L2-S1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TSM Cage
Arm Type
Experimental
Arm Description
Lumbar I/F with cage and pedicle screws
Intervention Type
Device
Intervention Name(s)
Lumbar I/F with cage and pedicle screws
Intervention Description
Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
Primary Outcome Measure Information:
Title
Radiographic Fusion
Title
Oswestry Disability Index
Title
Motor Function
Title
Adverse Events
Title
Secondary Surgical Interventions
Secondary Outcome Measure Information:
Title
SF-36
Title
Graft site pain
Title
Back pain
Title
Leg pain
Title
Disc space height

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Facility Information:
Facility Name
TSM Investigational Site A
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
TSM Investigational Site B
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States

12. IPD Sharing Statement

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

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