A Multi-Center Observational Study to Validate RNA-Biomarkers as Prognostic of Fracture Healing
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Proportion of subjects with correct predicted outcome
研究概览
简要总结
The purpose of this study is to test the accuracy of using RNA in blood as a way to forecast new fracture healing outcome.
详细描述
This study will follow a registry + biospecimen collection format. Subjects will be enrolled at participating Sites as they present for care for new traumatic appendicular skeletal fractures (0 - ≤7 Days post-injury) and will provide blood specimens for study analysis and future use at up to 4 post-injury windows of treatment (i.e., Window 1, 0 - ≤7 Days; Window 2, 8 - ≤14 days; Window 3, 15 - ≤42 Days; and Window 4, 43 - ≤84 Days post-injury).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, a potential subject must meet ALL of the following criteria:
- •Provision of informed consent for study participation for self in the English language as indicated by a signed and dated, current, and IRB-approved Informed Consent Form (ICF) from
- •patients making their own SOC clinical decisions prior to the time of the 1st blood sample collection, or
- •persons initially unable to make their own SOC clinical decisions, who regain capacity to make clinical care decisions after study blood sample collection during the enrollment window and/or before hospital discharge.
- •Patient is expected to receive follow-up SOC fracture care at the Site.
- •Either biological sex at birth (i.e., male or female).
- •Any self-determined gender or sexual preference.
- •Any race and/or ethnicity combination.
- •Age 18 years or older at the time of enrollment; no maximum age.
- •Body weight estimated to be or measured at ≥110 lbs.
- •Presentation for care within 7 calendar days of injury for at least one new traumatic fracture of any bone in the appendicular skeleton with or without additional fractures of the appendicular or axial skeleton and with or without any other traumatic injuries.
- •A qualifying fracture:
- •May be open or closed as locally defined per SOC.
- •May be displaced or non-displaced per SOC.
- •Must result from blunt or penetrating trauma.
- •May not be in a location of the body that was chronically paralyzed pre-trauma or has become permanently paralyzed because of the trauma.
- •Does not include traumatic amputation above the fracture Site for qualifying fractures
- •Index treatment plan:
- •May be operative or non-operative.
- •May include staged treatment with or without the use of external fixators, and/or antibiotic beads, and/or other planned intervention.
- •Does not include hemi- or total arthroplasty to treat the qualifying fracture.
- •Does not include amputation above the qualifying fracture.
- •In good general health as evidenced by clinical presentation and/or medical history and without any diagnoses that preclude a life expectancy of at least 2 years after injury.
- •No healed or unhealed fractures within 12 months prior to the event resulting in the qualifying fracture.
- •Blood collection through venipuncture at the volume and frequency per protocol is not contraindicated either through past medical history or current clinical status
- •45 CFR 46 Subpart B: For females of reproductive potential: not pregnant at the time of study enrollment.
- •CFR 46 Subpart C: Does not meet the CFR definition of Prisoner.
- •Other vulnerable populations:
- •Not an individual with pre-existing or newly acquired permanently impaired decision-making capacity , and/or
- •Not an individual who would be considered an economically or educationally disadvantaged person prior to the qualifying injury as determined by the Site study team per Site standards.
排除标准
- •An individual who meets ANY of the following criteria will be excluded from participation in this study:
- •Enrolled in another research study that requires any study-specific blood draws from 0 - ≤84 Days post-injury or a study that prohibits co-enrollment of any kind.
- •Traumatic injuries at presentation are limited to soft tissue injuries and/or axial skeletal fractures.
- •The presentation appendicular fractures is a result of pathological not traumatic mechanism
- •Any other circumstances that in the opinion of the PI would either put the successful completion of the study at risk, and/or which makes study participation unduly burdensome to the Subject.
研究组 & 干预措施
New Traumatic Fractures
Anyone age 18 or over presenting to participating sites for care of new, traumatic appendicular fractures.
干预措施: Blood draws to assess RNA expression levels (Other)
结局指标
主要结局
Proportion of subjects with correct predicted outcome
时间窗: 0 - 270 days
The proportion of Subjects who have a correctly prognosed Fracture Healing Outcome (Normal Healing vs. Delayed Healing vs Nonunion) via RNA in peripheral blood when captured during four specific Windows: 1. 0 - ≤7 Days post-injury; and/or 2. 8 - ≤14 days post-injury; and/or 3. 15 - ≤42 Days post-injury; and/or 4. 43 - ≤84 Days post-injury as compared to clinically determined outcomes up to 270 Days post-injury.
Intra-Patient Correlation
时间窗: 0 - 270 days
The intra-patient correlation of RNA-biomarker-driven prognostic calls made by the blinded statistician across windows for those patients who contribute \>1 specimen for RNA-biomarker analysis.
次要结局
未报告次要终点