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The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.
This is a prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SImmetry Implant | Subjects who are indicated for the SImmetry Device according to the approved product labeling and inclusion/exclusion criteria will receive a SImmetry implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SImmetry Implant | Device | The SImmetry system is commercially available. The implanted devices consist of a range of thread-tapping cannulated implants designed to transfix the sacrum and ilim, providing stability for intra-articular fusion. The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion. |
| Measure | Description | Time Frame |
|---|---|---|
| SI Joint Fusion | Confirmed fusion of the SI joint at 12 and 24 months, defined as as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium. | 12 months |
| SI Joint Pain Reduction | SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| SI Joint Pain Reduction | SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits. | 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and representing candidates' for SIJ fusion.
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