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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorSI-BONE, Inc.

About this trial

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

Eligibility criteria

Qualifiers

≥ 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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • iFuse TORQ TNT Implant System

Treatment groups

120 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators