Recruiting NCT07530497

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

— Observational Fracture; Pelvic Insufficiency Fractures Fragility Fracture Sacroiliac; Fusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: iFuse TORQ TNT Implant System.
Who it may be relevant to: Registry conditions: Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture, Sacroiliac; Fusion. Basic parameters: from 60 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

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.

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.

Secondary outcome measures (1)

Safety endpoint: Proportion of Participants with ≥1 Serious Adverse Event (SAE) [Time frame: 12 months]

≥ 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
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT07530497 · 303203