Digital Aftercare for Wrist and Clavicle Fractures

NCT07055139 | Not Yet Recruiting

• 1 other identifier: 2025-00830
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

distal radius fracture; clavicle fracture; digital aftercare; app-based aftercare; App-Based Rehabilitation; Wrist Fracture; Fracture Recovery; Functional Outcome; QuickDASH; PRWE; eHealth; Patient Satisfaction; Quality of Life; EQ-5D; Complication Rate; Postoperative Care

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks postoperatively

• 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.

  12 weeks postoperatively

Secondary Outcomes (9)

• Range of Motion

  12 weeks postoperatively

• Patient Satisfaction

  12 weeks postoperatively

• Health-Related Quality of Life

  12 weeks postoperatively

• Complication Rates

  12 weeks postoperatively

• Healthcare Costs

  12 weeks postoperatively

Study Arms (2)

Traditional Aftercare

ACTIVE COMPARATOR

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.

Behavioral: Traditional Aftercare

Digital Aftercare

EXPERIMENTAL

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.

Behavioral: Digital Aftercare

Interventions

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.

Digital Aftercare

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.

Traditional Aftercare

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Wrist Fractures; Patient Satisfaction

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Frank Beeres, Prof. MD

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Torrez, MD

CONTACT

0041768221316; carlos.torrez@luks.ch

Bryan Van de Wall, MD, PhD

CONTACT

bryan.vandewall@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

CH (1)