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临床试验/NCT07060664
NCT07060664尚未招募不适用

Review of Proximal Humerus Fracture Outcomes

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年9月1日最近更新:

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

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

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory Iovanel

Principal Investigator

University of Massachusetts, Worcester

研究点 (2)

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