Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
SI-BONE, Inc.
Summary
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
Description
REBAR is a prospective, multicenter, single arm, post-market observational study conducted in a real-world setting on the usage of iFuse TORQ TNT.
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥ 60 years of age at screening 2. 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 3. Diagnostic imaging (X-ray and CT) showing fracture of the pelvis that correlates with pain location 4. Patient is scheduled for pelvic fixation using at least one iFuse TORQ TNT 5. Patient and/or patient's legally authorized representative (LAR) understands and is willing and able to provide written informed consent 6. Patient agrees to comply with…
Interventions
- DeviceiFuse TORQ TNT Implant System
FDA-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.
Location
- Orthopaedic Associates of ReadingWyomissing, Pennsylvania