Not Yet RecruitingNot Applicable

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

120 participantsStarted 2026-08

Plain-language summary

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

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥ 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

✕. 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

Composite Measure

Timeframe: 6-months

NCT IDNCT07530497

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-02

Director of Clinical Affairs

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥ 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

✕. 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