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Not yet recruiting NCT07055139

Digital Aftercare for Wrist and Clavicle Fractures

No phase Interventional Distal Radius Fracture Clavicle Fracture Postoperative Care Patient-Reported Outcome Measures (PROMs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital Aftercare, Traditional Aftercare.
Who it may be relevant to
Registry conditions: Distal Radius Fracture, Clavicle Fracture, Postoperative Care, Patient-Reported Outcome Measures (PROMs). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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
  • 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.

Primary outcome measures

  • Functional Recovery at 12 Weeks (PRWE for distal radius) [Time frame: 12 weeks postoperatively]
  • Functional Recovery at 12 Weeks (QuickDASH for clavicle) [Time frame: 12 weeks postoperatively]
Secondary outcome measures (9)
  • Range of Motion [Time frame: 12 weeks postoperatively]
  • Patient Satisfaction [Time frame: 12 weeks postoperatively]
  • Health-Related Quality of Life [Time frame: 12 weeks postoperatively]
  • Complication Rates [Time frame: 12 weeks postoperatively]
  • Healthcare Costs [Time frame: 12 weeks postoperatively]
  • Work Disability [Time frame: 12 weeks postoperatively]
  • User Experience with Digital Program (Digital Group Only) [Time frame: 12 weeks postoperatively]
  • Number of Completed Exercise Sessions in Digital Program (Digital Group Only) [Time frame: 12 weeks postoperatively]
  • Login Frequency in Digital Program (Digital Group Only) [Time frame: 12 weeks postoperatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Luzerner Kantonsspital — Lucerne

Identifiers

NCT: NCT07055139 · 2025-00830

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗