Digital Aftercare for Wrist and Clavicle Fractures

NCT ID: NCT07055139

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-03-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Aftercare

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.

Group Type: ACTIVE_COMPARATOR

Traditional Aftercare

Intervention Type: BEHAVIORAL

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.

Digital Aftercare

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.

Group Type: EXPERIMENTAL

Digital Aftercare

Intervention Type: BEHAVIORAL

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 complications.

Interventions

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 complications.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Beeres, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Locations

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, Switzerland

Countries

Switzerland

Central Contacts

Carlos Torrez, MD

Role: CONTACT

carlos.torrez@luks.ch

0041768221316

Bryan Van de Wall, MD, PhD

Role: CONTACT

bryan.vandewall@luks.ch

Facility Contacts

Carlos Torrez, MD

Role: primary

carlos.torrez@luks.ch

0041 76 822 13 16

Other Identifiers

2025-00830

Identifier Type: -

Identifier Source: org_study_id