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.
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGOrthopaedic Associates of Reading
Wyomissing, Pennsylvania, United States
RECRUITINGComposite 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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