NCT07530497招募中不适用
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Composite Measure
研究概览
简要总结
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
详细描述
REBAR is a prospective, multicenter, single arm, post-market observational study conducted in a real-world setting on the usage of iFuse TORQ TNT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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
研究组 & 干预措施
FFP using iFuse TORQ TNT.
Patients with fragility fractures of the pelvis (FFP) treated with surgical fixation using iFuse TORQ TNT.
干预措施: iFuse TORQ TNT Implant System (Device)
结局指标
主要结局
Composite Measure
时间窗: 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
次要结局
- Safety endpoint(12 months)
- Safety endpoint: Proportion of Participants with ≥1 Serious Adverse Event (SAE)(12 months)
研究者
研究点 (2)
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