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Clinical Trials in the USA / NCT07530497
Recruiting Observational

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

NCT07530497 · tracked via the Priya Life Science USA tracker
Sponsor
SI-BONE, Inc.
Phase
Observational
Started
2026-08
Last updated
2026-08-24

Condition(s) studied

Fracture; PelvicInsufficiency FracturesFragility FractureSacroiliac; FusionSacroiliac Joint DisruptionSacroiliac Joint Dysfunction

Investigational drug(s) / intervention(s)

iFuse TORQ TNT Implant System

iFuse 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.

Study summary

The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.

Eligibility

Sex
ALL
Min age
60 Years
Max age
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 study schedule of assessments 7. Patient and/or patient's proxy can complete study-related surveys 8. Patient was able to ambulate prior to index fracture Exclusion Criteria: 1. Any known anatomic issues that could prevent placement of iFuse TORQ TNT 2. Implants already in the pelvis (e.g. lumbopelvic fixation) that could interfere with placement of the study device(s) 3. Patient requires lumbosacral pelvic fixation as part of index procedure 4. 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. 5. Estimated lifespan \< 12 months 6. Presence of tumor, lytic lesion, infection, or soft tissues that precludes safe internal fixation 7. Not candidate for surgery due to underlying medical illness 8. Social situation that makes 12-month follow-up unlikely 9. History of recent (within 1 year) non-index pelvic fracture with non-union 10. Other clinically active fragility fracture of spine, hip or arms/legs that could impair recovery from sacral fracture 11. Known allergy to titanium or titanium alloys 12. Known or suspected active drug or alcohol abuse, including opioids 13. Patient is a prisoner or ward of the state 14. Patient is already participating in an investigational clinical trial that may interfere with implant placement or study follow-up

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Mayo Clinic Rochester Minnesota Recruiting
Orthopaedic Associates of Reading Wyomissing Pennsylvania Recruiting

More SI-BONE, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07530497 on ClinicalTrials.gov ↗ ← All trials in the USA