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.
Study Type
OBSERVATIONAL
Enrollment
120
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.
Composite Measure
The participant is considered a success if all of the following apply: * No breakage of study device on any radiographic study * No detectable migration or backout of study device compared to immediate postop or end-of-procedure view * No revision surgery related to the study device
Time frame: 6-months
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
Time frame: 12 months
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