Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
Recruitment status was Active, not recruiting
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.
Degenerative Disc Disease
Device: Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Radiographic Fusion
- Oswestry Disability Index
- Motor Function
- Adverse Events
- Secondary Surgical Interventions
- Graft site pain
- Back pain
- Leg pain
- Disc space height
|Study Start Date:||December 2000|
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
Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
|United States, Alabama|
|TSM Investigational Site A|
|Dothan, Alabama, United States, 36301|
|United States, Indiana|
|TSM Investigational Site B|
|Fort Wayne, Indiana, United States, 46825|