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The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
REBAR is a prospective, multicenter, single arm, post-market observational study conducted in a real-world setting on the usage of iFuse TORQ TNT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFP using iFuse TORQ TNT. | Patients with fragility fractures of the pelvis (FFP) treated with surgical fixation using iFuse TORQ TNT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFuse TORQ TNT Implant System | Device | FDA-clear implant used for fracture fixation of the pelvis, including acute, non-acute, and non-traumatic fractures and sacroiliac joint fusion for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Measure | The participant is considered a success if all of the following apply:
| 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Proportion of Participants with ≥1 Serious Adverse Event (SAE) | Proportion of participants with SAE probably or definitely related to study device or device placement procedure | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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The target patient population is patients with fragility fractures of the pelvis (FFP) in whom surgical fracture fixation is performed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Contact | 408-207-0700 | clinicalaffairs@si-bone.com |
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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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|
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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