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
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