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This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTI Spine products | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Rates | Rates of reoperation and/or revision procedures at index level | 1 month, 3 months, 6 months, 12 months, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion | Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.) | 1 month, 3 months, 6 months, 12 months, and 24 months |
| Radiographic Findings | Change in radiographic findings |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that have spinal problems requiring treatment with an RTI Surgical spine product.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabella M Rosales, BS | Contact | 406-924-5884 | irosales@xtantmedical.com | |
| Laura Henderson | Contact | 406-813-4107 | lhenderson@xtantmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Active, not recruiting | Hartford | Connecticut | 06102 | United States | |
There is no plan to share IPD
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| 1 month, 3 months, 6 months, 12 months, and 24 months |
| Adverse Events | Number of procedure and device related adverse events | 1 month, 3 months, 6 months, 12 months, and 24 months |
| Disability (Cervical) | Change in Neck Disability Index | 1 month, 3 months, 6 months, 12 months, and 24 months |
| Disability (non-Cervical) | Change in Oswestry Disability Index | 1 month, 3 months, 6 months, 12 months, and 24 months |
| Pain Change | Change in pain as determined by Visual Analogue Scale (VAS) | 1 month, 3 months, 6 months, 12 months, and 24 months |
| Time to Intervention | Time to first reoperation and/or revision procedure at index leve | 1 month, 3 months, 6 months, 12 months, and 24 months |
| Florida Back Institute |
| Active, not recruiting |
| Boca Raton |
| Florida |
| 33496 |
| United States |
| Spine Institute of South Florida | Active, not recruiting | Delray Beach | Florida | 33484 | United States |
| Suburban Orthopaedics | Terminated | Bartlett | Illinois | 60103 | United States |
| Indiana Spine Group | Withdrawn | Carmel | Indiana | 46032 | United States |
| DK Orthopedics | Completed | Crown Point | Indiana | 46307 | United States |
| Lindner Center for Research & Education at The Christ Hospit | Active, not recruiting | Cincinnati | Ohio | 45219 | United States |
| STENUM Ortho Fachklinik | Withdrawn | Ganderkesee | 27777 | Germany |
| Wirbelsäulenzentrum Fulda | Main | Kinzig | Active, not recruiting | Gelnhausen | 63571 | Germany |
| Katholisches Klinikum Koblenz - Montabaur | Withdrawn | Koblenz | D-56073 | Germany |
| St. Christopherus Krankenhaus - Katholisches Klinikum | Withdrawn | Werne | 59368 | Germany |
| Hospital Nacional de Parapléjicos | Recruiting | Toledo | 45004 | Spain |
|
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D013122 | Spinal Diseases |
| D013130 | Spinal Stenosis |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
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