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

NCT07530497 | Not Yet Recruiting FDA Device

• 1 other identifier: 303203
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fracture; Pelvic; Insufficiency Fractures; Fragility Fracture; Sacroiliac; Fusion; Sacroiliac Joint Disruption; Sacroiliac Joint Dysfunction

Keywords

Fragility Fracture; pelvic fracture; Osteoporotic pelvic fracture; Fragility Fracture of the pelvis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety endpoint: Proportion of Participants with ≥1 Serious Adverse Event (SAE)

  12 months

Study Arms (1)

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

Interventions

iFuse TORQ TNT Implant System DEVICE

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.

FFP using iFuse TORQ TNT.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• History of recent (within 1 year) non-index pelvic fracture with non-union
• Other clinically active fragility fracture of spine, hip or arms/legs that could impair recovery from sacral fracture
• Known allergy to titanium or titanium alloys
• Known or suspected active drug or alcohol abuse, including opioids
• Patient is a prisoner or ward of the state
• Patient is already participating in an investigational clinical trial that may interfere with implant placement or study follow-up

Sponsors & Collaborators

• SI-BONE, Inc.: lead

MeSH Terms

Conditions

Hip Fractures; Fractures, Stress

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Director of Clinical Affairs

CONTACT

408-207-0700; clinicalaffairs@si-bone.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share