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The objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.
Patients with degenerative sacroiliitis or sacroiliac joint disruption who already had the CATAMARAN Fixation Device implanted between 6 and 12 months will be asked to return for follow-up visit to evaluate clinical outcomes and undergo a high resolution pelvic CT-Scan to assess fusion. Additionally, retrospective clinical outcomes will be collected from the medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CATAMARAN SI Joint Fusion System | Other | Subjects previously treated with the CATAMARAN Fixation Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic CT Scan | Radiation | Pelvic CT-Scan between 6-12 months post-op |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Fusion | The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist. | 6-12 month post CATAMARAN Fixation Device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Device Status | Radiographic assessment for device status: device placement, loosening, migration and/or breakage | 6-12 months post-op |
| Surgical re-intervention for SI joint pain | Proportion of patients requiring surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minimally Invasive Neurosurgery of Texas | Plano | Texas | 75024 | United States | ||
| St. George Orthopaedic Spine |
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| 6-12 months post-op |
| Neurologic worsening related to the sacral spine | Proportion of patients experiencing neurologic worsening related to the sacral spine compared to baseline | 6-12 months post-op |
| Serious device related adverse events | Summary of all serious device related adverse events | 6-12 months post-op |
| St. George |
| Utah |
| 84790 |
| United States |