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NCT07530497Recruiting

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

SI-BONE, Inc.

Start Date

8/1/2026

Completion Date

8/1/2028

Summary

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

Detailed 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 Criteria

Age Range: 60 years to No maximum

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

Interventions

DEVICE

iFuse TORQ TNT Implant System

Interested in This Trial?

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Conditions

Fracture; PelvicInsufficiency FracturesFragility FractureSacroiliac; FusionSacroiliac Joint DisruptionSacroiliac Joint Dysfunction

Locations

Mayo Clinic

Rochester, Minnesota 55905

United States

Orthopaedic Associates of Reading

Wyomissing, Pennsylvania 19610

United States