The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 7
- 主要终点
- Teftom Questionnaire
研究概览
简要总结
Design:
Prediction trial, up to 10 sites in Asia and Europe
Goal:
To better understand the "success" or "failure" after orthopedic trauma surgery by developing a model that can be applied clinically as a user-friendly "baseline" questionnaire - capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome and to validate a novel outcomes measure (TOM).
Primary aim:
To assess the psychometric properties of predictive validity, internal consistency and reproducibility of the trauma expectation factor (TEF) in the Eurasian population.
Secondary aim:
To assess the psychometric properties of criterion validity, internal consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population.
Key questions related to patient and surgeon expectations:
- How different, or similar, are patient and surgeon expectations?
- Do expectations change over time?
- Do patient expectations predict outcomes in validated measures use today?
研究设计
- 研究类型
- Observational
- 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
- •Isolated ankle or distal tibia fracture
- •Scheduled for and undergoing one of the following surgeries for their fracture:
- •Open fracture and internal fixation (ORIF)
- •external fixation (EF)
- •EF followed by ORIF
- •18 years of age or older
- •Understand and read country national language at elementary level
- •Able to understand the purpose of the clinical trial,
- •Able and willing to conduct all follow-up visits
- •Signed informed consent
排除标准
- •Subject has previously undergone internal fixation surgery for this ankle/distal tibia fracture.
- •Subject has disease entity, or condition that precludes likelihood of bony union (e.g., metastatic cancer, metabolic bone disease).
- •Subject has severe dementia or other severe mental health problem that may preclude him/her from completing study questionnaires.
- •Subject is participating in other competing clinical research that may interfere with participation in this research.
- •Subject is unlikely to attend study related follow-up visits.
- •Subject has poly-trauma (more than one organ system compromised)
- •Subject has additional fracture(s) other than ankle fracture
- •Subject is a prisoner
- •Fracture occurred more than 28 days before surgery
结局指标
主要结局
Teftom Questionnaire
时间窗: one year
次要结局
未报告次要终点