Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Purpose
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
- Sacroiliac Joint Dysfunction
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 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
- 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
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| FFP using iFuse TORQ TNT. | Patients with fragility fractures of the pelvis (FFP) treated with surgical fixation using iFuse TORQ TNT. |
|
Recruiting Locations
Orthopaedic Associates of Reading
Wyomissing, Pennsylvania 19610
Wyomissing, Pennsylvania 19610
More Details
- Status
- Recruiting
- Sponsor
- SI-BONE, Inc.
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.