Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Recruiting now
Conditions studied: Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture, Sacroiliac; Fusion, Sacroiliac Joint Disruption, Sacroiliac Joint Dysfunction
In brief
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
Key facts
- Study ID
- NCT07530497
- Run by
- SI-BONE, Inc.
- People needed
- 120
- Starts
- 2026-08-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- Orthopaedic Associates of Reading — Wyomissing, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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