Comparison of Digital Versus Traditional Aftercare for Uncomplicated Distal Radius and Clavicle Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Functional Recovery at 12 Weeks (PRWE for distal radius)
研究概览
简要总结
This prospective, two-arm, open-label clinical trial compares digital aftercare with traditional follow-up in adult patients after surgical treatment of uncomplicated distal radius or clavicle fractures. The primary objective is to assess functional recovery at three months, using the Patient-Rated Wrist Evaluation (PRWE) for wrist fractures and the QuickDASH for clavicle fractures. Secondary outcomes include range of motion, patient satisfaction, quality of life, complication rates, healthcare costs, and work disability. In the digital aftercare group, program adherence and user experience will also be evaluated through app usage data and a structured questionnaire. The study aims to determine whether digital aftercare is a clinically and economically equivalent alternative to standard in-person care.
详细描述
This is a prospective, open-label, two-arm clinical trial designed to compare digital aftercare with traditional in-person follow-up in adult patients (aged 18-65) who have undergone uncomplicated surgical treatment for distal radius or clavicle fractures.
Participants in the digital aftercare group receive a structured, app-based rehabilitation program over 12 weeks. The program includes video-guided physiotherapy exercises, educational content, and recovery milestones. Clinical follow-up and physiotherapy are replaced by the digital program, with medical consultations available only if clinically necessary. Adherence and user experience are tracked via app usage data and a structured questionnaire.
Participants in the traditional aftercare group receive standard postoperative care, including regular clinical follow-up visits and supervised physiotherapy sessions based on institutional guidelines.
The primary objective of this study is to evaluate whether digital aftercare results in equivalent functional outcomes compared to traditional follow-up. Functional recovery is assessed at 12 weeks using the QuickDASH (for clavicle fractures) and PRWE (for distal radius fractures).
Secondary outcomes include range of motion, patient satisfaction (VAS), quality of life (EQ-5D), complication rates (Clavien-Dindo classification), direct and indirect healthcare costs, return to work, and - in the digital group - program adherence and user feedback.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Surgically treated, uncomplicated distal radius or clavicle fracture
- •Use of a smartphone (iOS or Android)
- •Ability to understand German and complete study-related questionnaires
- •Provided written informed consent
排除标准
- •Polytrauma or additional injuries to the same upper extremity
- •No access to or inability to use a smartphone
- •Cognitive, psychiatric, or language barriers impairing participation
- •Pregnancy
- •Inability or unwillingness to comply with the study protocol
结局指标
主要结局
Functional Recovery at 12 Weeks (PRWE for distal radius)
时间窗: 12 weeks postoperatively
Functional outcome will be assessed using the Patient-Rated Wrist Evaluation (PRWE) score. The PRWE is a validated questionnaire specifically designed to evaluate wrist function and pain. Scores range from 0 to 100, with lower scores indicating better functional outcomes.
Functional Recovery at 12 Weeks (QuickDASH for clavicle)
时间窗: 12 weeks postoperatively
Functional outcome will be assessed using the QuickDASH (Disabilities of the Arm, Shoulder and Hand - Short Version) score. The QuickDASH is a validated tool to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. Scores range from 0 to 100, with lower scores indicating better function.
次要结局
- Range of Motion(12 weeks postoperatively)
- Patient Satisfaction(12 weeks postoperatively)
- Health-Related Quality of Life(12 weeks postoperatively)
- Complication Rates(12 weeks postoperatively)
- Healthcare Costs(12 weeks postoperatively)
- Work Disability(12 weeks postoperatively)
- User Experience with Digital Program (Digital Group Only)(12 weeks postoperatively)
- Number of Completed Exercise Sessions in Digital Program (Digital Group Only)(12 weeks postoperatively)
- Login Frequency in Digital Program (Digital Group Only)(12 weeks postoperatively)