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The purpose of this study is to prospectively review outcomes of patients who have surgery with the ExcelsiusGPS™ robotics system in order to analyze screw placement accuracy. Patient demographics, intraoperative data and radiographic imaging to determine screw placement accuracy will be collected and reviewed. This information will be compared in a separate study to retrospectively collected data from sites who have done a similar number of cases without the robot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic | Experimental | Patients receiving spine surgery with posterior stabilization placed by ExcelsiusGPS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExcelsiusGPS™ | Procedure | The ExcelsiusGPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (pre-operative CT, intra-operative CT and fluoroscopy), using a dynamic reference base and positioning camera. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale | Pain rating scale | Baseline |
| Numeric Rating Scale | Pain rating scale | 2 weeks |
| Numeric Rating Scale | Pain rating scale | 3 months |
| Numeric Rating Scale | Pain rating scale | 6 months |
| Numeric Rating Scale | Pain rating scale | 12 months |
| Numeric Rating Scale | Pain rating scale | 24 months |
| Oswestry Disability Index | Index derived from the Oswestry Low Back Pain Questionnaire | Baseline |
| Oswestry Disability Index | Index derived from the Oswestry Low Back Pain Questionnaire | 2 weeks |
| Oswestry Disability Index | Index derived from the Oswestry Low Back Pain Questionnaire | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha Greeley, BS | Contact | 6109301800 | 2509 | sgreeley@globusmedical.com |
| Brandon Bucklen, PhD | Contact | 6109301800 | 2517 | bbucklen@globusmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeastern Spine Institute | Recruiting | Mt. Pleasant | South Carolina | 29464 | United States |
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| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
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| Oswestry Disability Index | Index derived from the Oswestry Low Back Pain Questionnaire | 6 months |
| Oswestry Disability Index | Index derived from the Oswestry Low Back Pain Questionnaire | 12 months |
| Oswestry Disability Index | Index derived from the Oswestry Low Back Pain Questionnaire | 24 months |
| SF-12 | 12-Item short form health survey | Baseline |
| SF-12 | 12-Item short form health survey | 2 weeks |
| SF-12 | 12-Item short form health survey | 3 months |
| SF-12 | 12-Item short form health survey | 6 months |
| SF-12 | 12-Item short form health survey | 12 months |
| SF-12 | 12-Item short form health survey | 24 months |
| Screw Placement Accuracy | Gertzbein Robbins Scale for screw accuracy | 2 weeks |
| Complications | Adverse Event | through study completion, 2 years |