Distal Radius FractureNCT07872488
Enhancing Patient Engagement and Communication Through the Use of 3-Dimensional Printed Surgical Wrist Anatomy Models
A study testing 3D printed Distal Radius Fracture Model in people with Distal Radius Fracture and Distal Radius Fracture Fixation, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Single blinded Randomised Controlled Trial - standardised 3-Dimensional printed 1:1 distal radius fracture configuration - 60 patients. 30 in the control arm (standard consultation) vs 30 in the intervention (model-enhanced consultation). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture, Distal Radius Fracture Fixation
- What is being tested?
- 3D printed Distal Radius Fracture Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2025to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18+ patients
- distal radius fracture
- able to understand and speak English
- have an appointment with the orthopaedic surgeon to discuss their options.
Who cannot join
- not a distal radius fracture
- paediatric patients
- patients who have had the treatment for the distal radius fracture already (follow up appointments)
- patients who refuse consent for this trial
- patients who do not speak or understand English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital, Department of Orthopaedic Surgery
London, SW10 9NH
About this study
Single blinded Randomised Controlled Trial - standardised 3-Dimensional printed 1:1 distal radius fracture configuration - 60 patients. 30 in the control arm (standard consultation) vs 30 in the intervention (model-enhanced consultation). Questionnaire was created de novo for this study through Delphi process comparing like-for-like domains between the two cohorts. Additional exploratory analysis was done on standard consultation patients - were exposed to the model after the standard consultation and filled in a new questionnaire.
- Being tested
- 3D printed Distal Radius Fracture Model
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed Distal Radius Fracture ModelOther
A 1:1 size 3D printed distal radius fracture model (printed in-house from a CT) of a standard fracture configuration (decided by panel of consultants).
| Study group | Role | What they receive |
|---|---|---|
| Standard Consultation | No intervention | Patients undergo standard distal radius fracture consultation with a senior orthopaedic surgeon (fellow or consultant), using only clinical imaging to aid patient understanding. Patients fill in an appropriate questionnaire after this. After the consultation, as an exploratory analysis, patients are handled the model to appreciate and ask questions - a secondary questionnaire is filled in by the same patients. |
| Intervention (3-Dimensional printed model assisted consultation) | Experimental | Patients undergo a standard orthopaedic distal radius fracture consultation, but assisted with a 3D printed 1:1 distal radius fracture model. Patients then fill in an appropriate questionnaire. Receives: Other: 3D printed Distal Radius Fracture Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Overall Patient Questionnaire Score Following Consultation
Compare the mean overall questionnaire score between patients receiving standard imaging-based consultation and those receiving consultation supplemented by the 3D-printed model.
Measured: Immediately after the allocated study consultation, during the same clinic visit (Day of individual patient visit, up to week 21).
Secondary outcomes (3)
Mean Patient Questionnaire Domain Scores Following Consultation
Scores for each questionnaire domain will be compared between patients receiving standard imaging-based consultation and those receiving consultation supplemented by a 3D-printed model. The questionnaire assesses communication and decision making, emotional and psychological impact, general attitudes towards 3D printed models, understanding of the treatment and injury. Each domain score is calculated by an aggregate of statements ranked on a 5 point liker scale. Mean scores will be reported separately for each domain and study group.
Measured: Immediately after the allocated study consultation, during the same clinic visit (Day of individual patient visit, up to week 21).
Within-Participant Change in Overall Patient Questionnaire Score After Exposure to the 3D-Printed Model in the Control Group
Patients in the control group will complete the questionnaire after standard imaging-based consultation and again after subsequent exposure to the 3D-printed model. Within-participant change will be calculated as the post-model overall questionnaire score minus the pre-model score. The mean within-participant change will be reported for the control group.
Measured: Immediately after standard imaging-based consultation and again immediately after subsequent exposure to the 3D-printed model, both during the same clinic visit (Day of individual patient visit, up to week 21).
Patient-Reported Themes in Free-Text Feedback Following Consultation
Free-text questionnaire responses will undergo thematic analysis to identify recurring themes in patients' feedback about the consultation and, where applicable, the 3D-printed model. Identified themes will be described, with illustrative anonymised quotations. This assessment is qualitative and does not generate a numerical questionnaire score.
Measured: Free-text feedback collected immediately after the study consultation and, where applicable, subsequent exposure to the 3D-printed model, during the same clinic visit (Day of individual patient visit, up to week 21).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start3 Nov 2025
- Primary completion27 Mar 2026
- Study completion5 Oct 2026
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.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maxim Horwitz, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872488
- Sponsor's protocol ID
- QI 568
- Other IDs
- Award 0260
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Patient Engagement and Communication Through the Use of 3-Dimensional Printed Surgical Wrist Anatomy Models
- ClinicalTrials.gov ID
- NCT07872488
- Acronym / sponsor ID
- QI 568
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 13 Oct 2026 (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.
Single blinded Randomised Controlled Trial - standardised 3-Dimensional printed 1:1 distal radius fracture configuration - 60 patients. 30 in the control arm (standard consultation) vs 30 in the intervention (model-enhanced consultation). Questionnaire was created de novo for this study through Delphi process comparing like-for-like domains between the two cohorts. Additional exploratory analysis was done on standard consultation patients - were exposed to the model after the standard consultation and filled in a new questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Consultation | No intervention | –Patients undergo standard distal radius fracture consultation with a senior orthopaedic surgeon (fellow or consultant), using only clinical imaging to aid patient understanding. Patients fill in an appropriate questionnaire after this. After the consultation, as an exploratory analysis, patients are handled the model to appreciate and ask questions - a secondary questionnaire is filled in by the same patients. |
| Intervention (3-Dimensional printed model assisted consultation) | Experimental | Other: 3D printed Distal Radius Fracture ModelPatients undergo a standard orthopaedic distal radius fracture consultation, but assisted with a 3D printed 1:1 distal radius fracture model. Patients then fill in an appropriate questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18+ patients
- distal radius fracture
- able to understand and speak English
- have an appointment with the orthopaedic surgeon to discuss their options.
Key exclusion criteria (5 listed)
- not a distal radius fracture
- paediatric patients
- patients who have had the treatment for the distal radius fracture already (follow up appointments)
- patients who refuse consent for this trial
- patients who do not speak or understand English
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 |
|---|---|---|
| 3D printed Distal Radius Fracture ModelA 1:1 size 3D printed distal radius fracture model (printed in-house from a CT) of a standard fracture configuration (decided by panel of consultants). | Other | Intervention (3-Dimensional printed model assisted consultation) |
Primary outcome
Mean Overall Patient Questionnaire Score Following Consultation
Time frame: Immediately after the allocated study consultation, during the same clinic visit (Day of individual patient visit, up to week 21).
Compare the mean overall questionnaire score between patients receiving standard imaging-based consultation and those receiving consultation supplemented by the 3D-printed model.
3 secondary outcomes
Mean Patient Questionnaire Domain Scores Following Consultation
Time frame: Immediately after the allocated study consultation, during the same clinic visit (Day of individual patient visit, up to week 21).
Within-Participant Change in Overall Patient Questionnaire Score After Exposure to the 3D-Printed Model in the Control Group
Time frame: Immediately after standard imaging-based consultation and again immediately after subsequent exposure to the 3D-printed model, both during the same clinic visit (Day of individual patient visit, up to week 21).
Patient-Reported Themes in Free-Text Feedback Following Consultation
Time frame: Free-text feedback collected immediately after the study consultation and, where applicable, subsequent exposure to the 3D-printed model, during the same clinic visit (Day of individual patient visit, up to week 21).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed Distal Radius Fracture Model in people with Distal Radius Fracture and Distal Radius Fracture Fixation, run by Imperial College London at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 23 Oct 2026. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Overall Patient Questionnaire Score Following Consultation (time frame: Immediately after the allocated study consultation, during the same clinic visit (Day of individual patient visit, up to week 21).). 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 23 Oct 2026.