About this trial
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
Eligibility criteria
Qualifiers
≥ 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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- iFuse TORQ TNT Implant System