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NCT07530497
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Conditions: Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture, Sacroiliac; Fusion, Sacroiliac Joint Disruption, Sacroiliac Joint Dysfunction
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Enrollment: 120
Sponsor: SI-BONE, Inc.
Location: Mayo Clinic Rochester Minnesota
Summary
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07530497). StuddyBuddy aggregates publicly available trial information.