Recruiting

iFuse TORQ TNT

Sponsor:

SI-BONE, Inc.

Code:

NCT07530497

Conditions

Fracture; Pelvic

Insufficiency Fractures

Fragility Fracture

Sacroiliac; Fusion

Sacroiliac Joint Disruption

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

iFuse TORQ TNT Implant System

Study Details

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

Study ID

NCT07530497

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

FFP using iFuse TORQ TNT.

Patients with fragility fractures of the pelvis (FFP) treated with surgical fixation using iFuse TORQ TNT.

Interventions

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.

Primary outcome measure

  • Composite Measure [ Time Frame: 6-months ]

Central Contacts and Locations

Central contacts

Director of Clinical Affairs

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Orthopaedic Associates of Reading

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Contacts

More Information

Sponsor

SI-BONE, Inc.

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SI-BONE, Inc. on 2026-08-24.