Sacral Fracture Fusion/Fixation for Rapid Rehabilitation

Who can take part

• ≥ 60 years of age at screening
• Posterior pelvic pain correlating with fracture location that began EITHER within 14 days of a low-energy traumatic event, OR in the last 60 days in the absence of a traumatic event
• Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)
• Patient is either bedbound or must use a wheelchair to cover distances more than 50ft
• Prior to fracture, patient was able to ambulate using a cane or unassisted
• Medically stable to undergo either surgical or non-surgical treatment of index fracture
• Patient is willing and able to provide written informed consent
• Patient is mentally able to comply with study protocol requirements

Who cannot take part

• Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)
• Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum
• Any permanent implants already in the sacrum (including cement), ilium, or anterior pelvic ring that could interfere with placement of transiliac transsacral or iliosacral screws or iFuse-TORQ implants
• Known or suspected active drug or alcohol abuse, including opioids
• History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium
• Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments
• Prominent neurologic condition that would interfere with study participation including the use of electronic diaries (e.g., dementia) or recovery of mobility (e.g., severe diabetic neuropathy, multiple sclerosis)
• Known allergy to titanium or titanium alloys
• Current local or systemic infection that raises the risk of surgery
• Sacral fracture potentially or definitely related to tumor
• Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture
• Patient lives or plans to move more than 100 miles from the site during the course of the study
• Current enrollment in another investigational clinical trial related to fractures or osteoporosis