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This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implanted TransLoc 3D SIJ Fusion Patients | Patients who were diagnosed with sacroiliitis and were treated with the TransLoc 3D System ≥ 1 year ≤ 18 months at the time of consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransLoc 3D SI Joint Fusion System | Device | Satisfaction survey will be administered to collect real world evidence on patients that previously received the TransLoc 3D System commercially. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Survey | Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint | Prospective 12 to 18 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) of pain | Retrospective analysis of VAS pre and post surgery, if available | Baseline up to 1 year post surgery |
| Oswestry Disability Index (ODI) | Retrospective analysis of ODI pre and post surgery, if available |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have already received the TransLoc 3D System > 1 year postoperatively < 18 months, at the time of consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carley Wiegner | Contact | 888-743-8736 | carley@cornerloc.com | |
| Bob Compton | Contact | bob@cornerloc.com |
| Name | Affiliation | Role |
|---|---|---|
| Lee James, DO | Advanced Orthopedic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Orthopedic Center | Recruiting | Port Charlotte | Florida | 33948 | United States |
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| Baseline up to 1 year post surgery |
| SAEs | Retrospective capture of Serious Adverse Events (SAEs) from the time of SI Fusion up to 90 days post operatively that required re-operation or in-patient hospitalization. | Time of surgery up to 90 days post surgery |
| CT Scan Second Read (Radiological Overread) | CT scan for placement and fusion | 12 to 18 months post fusion surgery |