Real World Study of SI-BONEs iFuse TORQ TNT Device for Treating Pelvic Fragility Fractures in Older Adults

What this Trial Is About

This research evaluates outcomes in patients aged 60 and older who have pelvic fragility fractures treated with the iFuse TORQ TNT implant system. The study focuses on real-world use of this FDA-cleared device, which is designed for pelvic fracture fixation and sacroiliac joint fusion related to various pelvic conditions including disruption and dysfunction. It is a prospective, multicenter, single-arm observational study conducted without randomization or placebo control. Participants receive surgical fixation of their pelvic fractures using the iFuse TORQ TNT implant. The study observes patients treated with this device in routine clinical settings and collects data on their recovery and safety over time. The treatment involves placement of at least one implant to stabilize pelvic fractures correlating with pain and limited mobility. During the study, participants will undergo diagnostic imaging such as X-rays and CT scans to confirm fracture location and monitor healing. They will complete surveys and follow a schedule of assessments over a 12-month period. The primary outcome is a composite measure at 6 months, and safety is monitored through recording serious adverse events up to 12 months. Participants mobility and physical function before and after treatment are also evaluated throughout the study.

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