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The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.
PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIJ Dysfunction treated with INTRA Ti | Patients with sacroiliac joint (SIJ) dysfunction due to various causes refractory to non-surgical management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFuse INTRA Ti Implant System | Device | FDA-cleared implant used for fusion of the sacroiliac joint (SIJ) for SIJ dysfunction, that is a direct result of SIJ disruption and degenerative sacroiliitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of safety and performance | The participant is considered a success if all the following criteria are met:
| 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with a Serious Adverse Event (SAE) | Proportion of participants with a serious adverse event classified as probably or definitely related to the study device or procedure | 24 months |
| Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with sacroiliac joint (SIJ) dysfunction due to degenerative sacroiliitis or sacroiliac joint disruption for at least 6 months refractory to non-surgical care
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Contact | 408-207-0700 | clinicalaffairs.@si-bone.com |
| Name | Affiliation | Role |
|---|---|---|
| Stacie Tran, MPH | SI-BONE | Study Director |
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There are currently no plans to share but IPD may be shared with qualified researchers upon reasonable request, subject to sponsor approval and data use agreements.
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Proportion of participants undergoing one or more SSI related to the index procedure. |
| 24 months |
| Proportion of Treated Sides with Radiographic Evidence of Loosening | Proportion of treated sides showing signs of loosening of INTRA Ti, as evidenced by both radiolucent areas around implant plus bony reaction ("rind") near implant. | 24 months |
| Proportion of Implants with Radiographic Evidence of Device Migration. | Proportion of INTRA Ti implants that show evidence of device migration. | 24 months |
| Proportion of Implants with Radiographic Evidence of Device Breakage. | Proportion of INTRA Ti implants that show breakage. | 24 months |
| Proportion of Participants with Radiographic Evidence of Fusion | Bony apposition to the implant at 12 months as evaluated by pelvic CT | 24 months |