See how well iFuse TORQ TNT works for pelvic fragility fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REBAR is a prospective, multicenter, single-arm study that observes patients treated with the iFuse TORQ TNT device in routine clinical practice. It focuses on outcomes after pelvic fixation for fragility-related pelvic fractures. The trial collects real-world data on safety, pain, mobility, and function without randomization or a control group. Participants are adults 60 years and older who require pelvic fixation with the device. The study aims to describe how the device performs outside of a controlled trial setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Twin Cities Orthopedics
  Edina, Minnesota, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Orthopaedic Associates of Reading
  Wyomissing, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Director of Clinical Affairs
• Email: clinicalaffairs@si-bone.com
• Phone: 408-207-0700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.