Digital Aftercare for Wrist and Clavicle Fractures

Официальное название

Comparison of Digital Versus Traditional Aftercare for Uncomplicated Distal Radius and Clavicle Fractures

Обзор

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.

Подробное описание

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.

This study also aims to explore the cost-effectiveness of digital aftercare and its potential as a scalable alternative to traditional rehabilitation in selected fracture patients.

Вмешательства

• Поведенческое Digital Aftercare
  A structured, app-based digital aftercare program designed for patients recovering from distal radius or clavicle fractures. The 12-week program includes weekly video-guided physiotherapy exercises, educational content on fracture healing, pain management guidance, and milestone-based progression. The program replaces in-person physiotherapy and standard clinic follow-up, with patients instructed to follow the app independently. Medical contact is initiated only in case of uncertainty or complic
• Поведенческое Traditional Aftercare
  Standard postoperative follow-up care for patients with distal radius or clavicle fractures, consisting of scheduled clinical visits and in-person physiotherapy sessions according to institutional protocols. The treatment includes individual exercise instruction, physiotherapy, and physician-led follow-up at defined intervals during the 12-week rehabilitation period.

Первичные конечные точки

• Functional Recovery at 12 Weeks (PRWE for distal radius) [Срок оценки: 12 weeks postoperatively]
• Functional Recovery at 12 Weeks (QuickDASH for clavicle) [Срок оценки: 12 weeks postoperatively]

Вторичные конечные точки (9)

• Range of Motion [Срок оценки: 12 weeks postoperatively]
• Patient Satisfaction [Срок оценки: 12 weeks postoperatively]
• Health-Related Quality of Life [Срок оценки: 12 weeks postoperatively]
• Complication Rates [Срок оценки: 12 weeks postoperatively]
• Healthcare Costs [Срок оценки: 12 weeks postoperatively]
• Work Disability [Срок оценки: 12 weeks postoperatively]
• User Experience with Digital Program (Digital Group Only) [Срок оценки: 12 weeks postoperatively]
• Number of Completed Exercise Sessions in Digital Program (Digital Group Only) [Срок оценки: 12 weeks postoperatively]
• Login Frequency in Digital Program (Digital Group Only) [Срок оценки: 12 weeks postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Luzerner Kantonsspital — Lucerne

Идентификаторы

NCT: NCT07055139 · 2025-00830

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗