Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring 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.

Inclusion criteria

• ≥ 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
• Patient and/or patient's legally authorized representative (LAR) understands and is willing and able to provide written informed consent
• Patient agrees to comply with study schedule of assessments
• Patient and/or patient's proxy can complete study-related surveys
• Patient was able to ambulate prior to index fracture

Exclusion criteria

• 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.
• Estimated lifespan < 12 months
• Presence of tumor, lytic lesion, infection, or soft tissues that precludes safe internal fixation
• Not candidate for surgery due to underlying medical illness
• Social situation that makes 12-month follow-up unlikely
• History of recent (within 1 year) non-index pelvic fracture with non-union
• Other clinically active fragility fracture of spine, hip or arms/legs that could impair recovery from sacral fracture
• Known allergy to titanium or titanium alloys
• Known or suspected active drug or alcohol abuse, including opioids
• Patient is a prisoner or ward of the state
• Patient is already participating in an investigational clinical trial that may interfere with implant placement or study follow-up