Digital Aftercare for Wrist and Clavicle Fractures

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLuzerner Kantonsspital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Digital Aftercare

    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.

  • Traditional Aftercare

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Traditional AftercareActive comparator 1 intervention
Group B: Digital AftercareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks postoperatively
2

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.

Time frame
12 weeks postoperatively

Secondary outcomes

1

Range of Motion

Goniometric assessment of wrist or shoulder range of motion in degrees, depending on fracture type.

Time frame
12 weeks postoperatively
2

Patient Satisfaction

Patient satisfaction measured using a Visual Analogue Scale (VAS, 0-10), with higher scores indicating greater satisfaction.

Time frame
12 weeks postoperatively
3

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.

Time frame
12 weeks postoperatively
4

Complication Rates

Surgical and postoperative complications classified according to the Clavien-Dindo classification system.

Time frame
12 weeks postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luzerner Kantonsspital

Lead sponsor

Johnson & Johnson

Collaborator

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