Review of Proximal Humerus Fracture Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- SANE
研究概览
简要总结
Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals 65 years of age or older with proximal humerus fractures
排除标准
- 未提供
结局指标
主要结局
SANE
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of treatment
"Sane outcome" typically refers to the Single Assessment Numeric Evaluation (SANE) score, a patient-reported outcome measure used in healthcare, particularly in orthopedics. It assesses a patient's perceived function of a joint or body region by asking them to rate it on a scale of 0 to 100, where 100 represents normal function
VAS
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
"VAS outcome" refers to the results obtained from using a Visual Analog Scale (VAS). The VAS is a measurement tool, typically a 10 cm or 100 mm line, where individuals indicate the intensity of a subjective experience, such as pain, by marking a point on the line. The distance from one end of the line to the patient's mark is then measured, and this measurement represents the VAS score. A higher score indicates a greater intensity of the experience being measured.
ASES
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
The American Shoulder and Elbow Surgeons scale (ASES) is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. A higher ASES score indicates better shoulder function and less pain, with a score of 100 representing the best possible outcome and a score of 0 representing the worst possible outcome.
EQ-5D-5L
时间窗: at baseline and subsequently at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
The EQ-5D-5L score represents a patient's self-reported health status, with values ranging from -0.59 to 1, where 1 indicates the best possible health. It's based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These responses are converted into a single index score using a scoring algorithm.
Brophy/Marx
时间窗: at baseline and subsequently at 12 months and 24 months after initiation of intervention
The Brophy-Marx Shoulder Activity Score is a valid and reliable shoulder-specific questionnaire that measures a patient's shoulder activity level over the previous year. The questionnaire generates a numeric score from 0 (least active) to 20 (most active).
PROMIS Social
时间窗: at 3 months, 12 months, and 24 months following initiation of intervention
PROMIS, or the Patient-Reported Outcomes Measurement Information System, uses T-scores to represent social health, with a mean of 50 and a standard deviation of 10 for the general US population. Higher T-scores generally indicate a greater amount of the measured concept, such as satisfaction with social roles and activities, while lower scores indicate less.
Radiographic Outcome
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
evidence of bony healing, nonunion, or malunion of the fracture on imaging
Complication Rate
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Rate of complications following initiation of management
Range of Motion (ROM)
时间窗: at 3 months, 6 months, 12 months, and 24 months from initiation of treatment
Range of Motion of the shoulder in terms of degrees of motion Assessment of forward flexion (0-180 degrees), abduction (0-90 degrees), external rotation (0-90 degrees)
SANE
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of treatment
"Sane outcome" typically refers to the Single Assessment Numeric Evaluation (SANE) score, a patient-reported outcome measure used in healthcare, particularly in orthopedics. It assesses a patient's perceived function of a joint or body region by asking them to rate it on a scale of 0 to 100, where 100 represents normal function
ASES
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
The American Shoulder and Elbow Surgeons scale (ASES) is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. A higher ASES score indicates better shoulder function and less pain, with a score of 100 representing the best possible outcome and a score of 0 representing the worst possible outcome.
Radiographic Outcome
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
evidence of bony healing, nonunion, or malunion of the fracture on imaging
Complication Rate
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Rate of complications following initiation of management
VAS
时间窗: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
"VAS outcome" refers to the results obtained from using a Visual Analog Scale (VAS). The VAS is a measurement tool, typically a 10 cm or 100 mm line, where individuals indicate the intensity of a subjective experience, such as pain, by marking a point on the line. The distance from one end of the line to the patient's mark is then measured, and this measurement represents the VAS score. A higher score indicates a greater intensity of the experience being measured.
EQ-5D-5L
时间窗: at baseline and subsequently at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
The EQ-5D-5L score represents a patient's self-reported health status, with values ranging from -0.59 to 1, where 1 indicates the best possible health. It's based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These responses are converted into a single index score using a scoring algorithm.
Brophy/Marx
时间窗: at baseline and subsequently at 12 months and 24 months after initiation of intervention
The Brophy-Marx Shoulder Activity Score is a valid and reliable shoulder-specific questionnaire that measures a patient's shoulder activity level over the previous year. The questionnaire generates a numeric score from 0 (least active) to 20 (most active).
PROMIS Social
时间窗: at 3 months, 12 months, and 24 months following initiation of intervention
PROMIS, or the Patient-Reported Outcomes Measurement Information System, uses T-scores to represent social health, with a mean of 50 and a standard deviation of 10 for the general US population. Higher T-scores generally indicate a greater amount of the measured concept, such as satisfaction with social roles and activities, while lower scores indicate less.
次要结局
未报告次要终点
研究者
Gregory Iovanel
Principal Investigator
University of Massachusetts, Worcester
