Digital Aftercare for Wrist and Clavicle Fractures

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07055139
• Lead Sponsor: Luzerner Kantonsspital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Start: 2025-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Recovery at 12 Weeks (PRWE for distal radius)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Range of Motion	12 weeks postoperatively	Goniometric assessment of wrist or shoulder range of motion in degrees, depending on fracture type.
Patient Satisfaction	12 weeks postoperatively	Patient satisfaction measured using a Visual Analogue Scale (VAS, 0-10), with higher scores indicating greater satisfaction.
Health-Related Quality of Life	12 weeks postoperatively	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	12 weeks postoperatively	Surgical and postoperative complications classified according to the Clavien-Dindo classification system.
Healthcare Costs	12 weeks postoperatively	Direct and indirect healthcare costs associated with each aftercare modality, including physiotherapy, consultations, and work absence.
Work Disability	12 weeks postoperatively	Duration of work absence stratified by job type (manual vs. non-manual work).
User Experience with Digital Program (Digital Group Only)	12 weeks postoperatively	Assessed with a structured questionnaire on usability, satisfaction, and perceived helpfulness of the app-based program.
Number of Completed Exercise Sessions in Digital Program (Digital Group Only)	12 weeks postoperatively	Adherence to the digital rehabilitation program will be measured by the number of completed exercise sessions recorded via the app. One session is counted as completed when all scheduled exercises for a given day are marked as done by the user.
Login Frequency in Digital Program (Digital Group Only)	12 weeks postoperatively	App usage will be monitored by tracking the total number of logins to the digital rehabilitation platform over the 12-week period. Each login is defined as a unique user access within a 24-hour window.

Trial Locations

Locations (1)

Luzerner Kantonsspital; 🇨🇭 Lucerne, Switzerland