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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.
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:
Secondary Endpoints Include:
Comparison:
Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSM Cage | Experimental | Lumbar I/F with cage and pedicle screws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar I/F with cage and pedicle screws | Device | Surgical Titanium Meshâ„¢ with MOSS-Miamiâ„¢ Pedicle Screws |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Fusion | ||
| Oswestry Disability Index | ||
| Motor Function | ||
| Adverse Events | ||
| Secondary Surgical Interventions |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 | ||
| Graft site pain | ||
| Back pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TSM Investigational Site A | Dothan | Alabama | 36301 | United States | ||
| TSM Investigational Site B |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D065289 | Pedicle Screws |
| ID | Term |
|---|---|
| D001863 | Bone Screws |
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Leg pain |
| Disc space height |
| Fort Wayne |
| Indiana |
| 46825 |
| United States |
| D009984 |
| Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |