About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Digital Aftercare
BehavioralA 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 complications.
Traditional Aftercare
BehavioralStandard 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.
Treatment groups
Trial outcomes
Primary outcomes
Functional Recovery at 12 Weeks (PRWE for distal radius)
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)
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.
Secondary outcomes
Range of Motion
Goniometric assessment of wrist or shoulder range of motion in degrees, depending on fracture type.
Patient Satisfaction
Patient satisfaction measured using a Visual Analogue Scale (VAS, 0-10), with higher scores indicating greater satisfaction.
Health-Related Quality of Life
Health-related quality of life will be measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Index scores typically range from less than 0 (where 0 represents a health state equivalent to death and negative values represent health states worse than death) to 1 (representing full health). Higher scores indicate better health-related quality of life.
Complication Rates
Surgical and postoperative complications classified according to the Clavien-Dindo classification system.
Sponsors and contacts
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Luzerner Kantonsspital
Lead sponsor
Johnson & Johnson
Collaborator
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