Digital Aftercare for Wrist and Clavicle Fractures (DA-DRAC)

Luzerner Kantonsspital

Status: Not yet enrolling

Conditions: Postoperative Care; Clavicle Fracture; Distal Radius Fracture; Upper Extremity Fractures; Patient-Reported Outcome Measures (PROMs)

Treatments: Behavioral: Traditional Aftercare; Behavioral: Digital Aftercare

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07055139

2025-00830

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Traditional Aftercare

Active Comparator group

Description:

Participants receive standard postoperative follow-up care, including scheduled clinical visits and in-person physiotherapy sessions, in accordance with institutional guidelines. Rehabilitation is delivered face-to-face and tailored to fracture type and recovery progress.

Treatment:

Behavioral: Traditional Aftercare

Digital Aftercare

Experimental group

Description:

A digital follow-up protocol delivered through a mobile app, focusing on independent functional recovery with physiotherapy exercises, educational modules, and symptom monitoring. Participants are guided through a week-by-week recovery plan specific to the fracture type.

Treatment:

Behavioral: Digital Aftercare