Fracture; Pelvic, Fragility Fracture, Insufficiency Fractures, Sacroiliac; Fusion, Sacroiliac Joint Disruption, Sacroiliac Joint Dysfunction
Conditions
Keywords
Fragility Fracture, pelvic fracture, Osteoporotic pelvic fracture, Fragility Fracture of the pelvis
Brief summary
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.
Interventions
DEVICEiFuse 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.
Sponsors
SI-BONE, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Measure | 6-months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint: Proportion of Participants with ≥1 Serious Adverse Event (SAE) | 12 months | Proportion of participants with SAE probably or definitely related to study device or device placement procedure |
Countries
United States
Contacts
CONTACTDirector of Clinical Affairs
Outcome results
None listed