The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
≥ 60 years of age at screening
Pelvic pain correlating with fracture location that began EITHER within 6 weeks of a known low-energy traumatic event, OR pelvic insufficiency fracture with pain that is limiting mobility
Diagnostic imaging (X-ray and CT) showing fracture of the pelvis that correlates with pain location
Patient is scheduled for pelvic fixation using at least one iFuse TORQ TNT
Any known anatomic issues that could prevent placement of iFuse TORQ TNT
Implants already in the pelvis (e.g. lumbopelvic fixation) that could interfere with placement of the study device(s)
Patient requires lumbosacral pelvic fixation as part of index procedure
Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation or regaining of physical function related to pelvic fracture and is unable to provide a health care proxy to complete study assessments.
The target patient population is patients with fragility fractures of the pelvis (FFP) in whom surgical fracture fixation is performed.
Case-only
Prospective
iFuse TORQ TNT Implant System
DeviceFDA-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
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
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