Distal Radius FractureDA-DRACNCT07055139
Digital Aftercare for Wrist and Clavicle Fractures
A study testing Digital Aftercare and Traditional Aftercare in people with Distal Radius Fracture and Clavicle Fracture, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture, Clavicle Fracture, Postoperative Care
- What is being tested?
- Digital Aftercare and Traditional Aftercare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bryan Van de Wall, MD, PhD contact
Switzerland1 site
Luzerner Kantonsspital
Lucerne, Canton of Lucerne, 6000
Carlos Torrez, MD, 0041 76 822 13 16, carlos.torrez@luks.ch
Carlos Torrez, MD
About this study
Official title: Comparison of Digital Versus Traditional Aftercare for Uncomplicated Distal Radius and Clavicle Fractures
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.
Read the 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
- Being tested
- Digital Aftercare, Traditional Aftercare
- 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
- Medical subject headings
- Wrist Fractures, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital AftercareBehavioural
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 AftercareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Digital Aftercare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks postoperatively
Secondary outcomes (9)
Range of Motion
Goniometric assessment of wrist or shoulder range of motion in degrees, depending on fracture type.
Measured: 12 weeks postoperatively
Patient Satisfaction
Patient satisfaction measured using a Visual Analogue Scale (VAS, 0-10), with higher scores indicating greater satisfaction.
Measured: 12 weeks postoperatively
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.
Measured: 12 weeks postoperatively
Complication Rates
Surgical and postoperative complications classified according to the Clavien-Dindo classification system.
Measured: 12 weeks postoperatively
Healthcare Costs
Direct and indirect healthcare costs associated with each aftercare modality, including physiotherapy, consultations, and work absence.
Measured: 12 weeks postoperatively
Work Disability
Duration of work absence stratified by job type (manual vs. non-manual work).
Measured: 12 weeks postoperatively
User Experience with Digital Program (Digital Group Only)
Assessed with a structured questionnaire on usability, satisfaction, and perceived helpfulness of the app-based program.
Measured: 12 weeks postoperatively
Number of Completed Exercise Sessions in Digital Program (Digital Group Only)
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.
Measured: 12 weeks postoperatively
Login Frequency in Digital Program (Digital Group Only)
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.
Measured: 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Frank Beeres, Prof. MD, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055139
- Sponsor's protocol ID
- 2025-00830
- Other IDs
- 2025
- Acronym
- DA-DRAC
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Digital Versus Traditional Aftercare for Uncomplicated Distal Radius and Clavicle Fractures
- ClinicalTrials.gov ID
- NCT07055139
- Acronym / sponsor ID
- DA-DRAC / 2025-00830
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Aftercare | Active comparator | Behavioral: Traditional AftercareParticipants 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. |
| Digital Aftercare | Experimental | Behavioral: Digital AftercareA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital AftercareA 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. | Behavioural | Digital Aftercare |
| Traditional AftercareStandard 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. | Behavioural | Traditional Aftercare |
Primary outcome
Functional Recovery at 12 Weeks (PRWE for distal radius)
Time frame: 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)
Time frame: 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan Van de Wall, MD, PhD contact
Frank Beeres, Prof. MD principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Aftercare and Traditional Aftercare in people with Distal Radius Fracture and Clavicle Fracture, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Torrez, MD (0041768221316, carlos.torrez@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Recovery at 12 Weeks (PRWE for distal radius) (time frame: 12 weeks postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.