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To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF.
This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training- CHARITE | Non-Randomized Training (TDR with CHARITE) |
| |
| CHARITE | Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE |
| |
| Control | Randomized Subjects treated by ALIF with BAK cage |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHARITE | Device | Lumbar Total Disc Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Success | ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline. | 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints | Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency | 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel H Stoutenburgh | DePuy Spine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite Site 13 | Los Angeles | California | 90048 | United States | ||
| Charite Site 06 |
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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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| Golden |
| Colorado |
| 80401 |
| United States |
| Charite Site 11 | Chicago | Illinois | 60640 | United States |
| Charite Site 03 | Louisville | Kentucky | 40202 | United States |
| Charite Site 02 | Towson | Maryland | 21204 | United States |
| Charite Site 15 | Boston | Massachusetts | 02120 | United States |
| Charite Site 14 | Lockport | New York | 14094 | United States |
| Charite Site 10 | New York | New York | 10003 | United States |
| Charite Site 07 | Columbus | Ohio | 43214 | United States |
| Charite Site 01 | Plano | Texas | 75093 | United States |