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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: Lumbar I/F with cage and pedicle screws


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Fusion |  |  | 
| Oswestry Disability Index |  |  | 
| Motor Function |  |  | 
| Adverse Events |  |  | 
| Secondary Surgical Interventions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 |  |  | 
| Graft site pain |  |  | 
| Back pain |  |  | 
| Leg pain |  |  | 
| Disc space height |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative disc disease at up to 2 levels (L2-S1)