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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Fragility Fracture; Sacroiliac Joint Disruption; Insufficiency Fractures; Sacroiliac Joint Dysfunction; Sacroiliac; Fusion; Fracture; Pelvic
• Intervention / Treatment: Device: iFuse TORQ TNT Implant System

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Director of Clinical Affairs; Phone Number: 408-207-0700; Email: clinicalaffairs@si-bone.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target patient population is patients with fragility fractures of the pelvis (FFP) in whom surgical fracture fixation is performed.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FFP using iFuse TORQ TNT.; Patients with fragility fractures of the pelvis (FFP) treated with surgical fixation using iFuse TORQ TNT.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Measure	The participant is considered a success if all of the following apply: No breakage of study device on any radiographic study; No detectable migration or backout of study device compared to immediate postop or end-of-procedure view; No revision surgery related to the study device	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint: Proportion of Participants with ≥1 Serious Adverse Event (SAE)	Proportion of participants with SAE probably or definitely related to study device or device placement procedure	12 months

Collaborators and Investigators

• Sponsor: SI-BONE, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Fragility Fracture; pelvic fracture; Osteoporotic pelvic fracture; Fragility Fracture of the pelvis
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Stress
• Other Study ID Numbers: 303203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are currently no plans to share but IPD may be shared with qualified researchers upon reasonable request, subject to sponsor approval and data use agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes