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CompletedNCT07872488Updated Oct 23, 2026

Enhancing Patient Engagement and Communication Through the Use of 3-Dimensional Printed Surgical Wrist Anatomy Models

An interventional study of 3D printed Distal Radius Fracture Model in Distal Radius Fracture and Distal Radius Fracture Fixation, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Imperial College London · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Nov 2025, registered Oct 2026).
Updated Oct 23, 2026Primary outcomes revisedInterventions changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Distal Radius Fracture
  • Distal Radius Fracture Fixation

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03

In context

Wrist Fractures

329 studies on the registry are indexed under Wrist Fractures; 69 are open to participants now.

This study's enrollment of 60 is close to the median of 63 across 267 interventional studies indexed under Wrist Fractures.

Browse Wrist Fractures studies →

Lead sponsor

Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18+ patients
  • distal radius fracture
  • able to understand and speak English
  • have an appointment with the orthopaedic surgeon to discuss their options.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    Standard Consultation

    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.

  • Experimental
    Intervention (3-Dimensional printed model assisted consultation)

    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.

    Other: 3D printed Distal Radius Fracture Model

Interventions

  • Other3D printed Distal Radius Fracture Model

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after the allocated study consultation, during the same clinic visit (Day of individual patient visit, up to week 21).

Secondary outcomes

  1. 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.

    Time frame: Immediately after the allocated study consultation, during the same clinic visit (Day of individual patient visit, up to week 21).

  2. 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.

    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).

  3. 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.

    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).

07

Study locations

1 site
  • Chelsea and Westminster Hospital, Department of Orthopaedic Surgery
    London, SW10 9NH, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2025 to primary completion in Mar 2026, 4 months.

Of 120 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's 4 months is below that.

Counting every sponsor, half of 121 studies reached it within 26 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartActual
Nov 3, 2025
Primary completionActual
Mar 27, 2026
CompletionActual
Oct 5, 2026
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Also revised
primary outcomes and interventions
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 23, 2026
    Primary outcomes Revised (2 changes)
    Interventions Arms or interventions changed
    + 4 other changes: identifiers, responsible party, description and secondary outcomes
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07872488
Responsible party
Maxim Horwitz (Principle Investigator, Consultant Orthopaedic Surgeon, Honorary Clinical Senior Lecturer: Department of Surgery & Cancer - Faculty of Medicine, Imperial College London) — Principal investigator
First posted
Oct 13, 2026
Start date
Nov 3, 2025
Primary completion
Mar 27, 2026
Completion
Oct 5, 2026
Last update
Oct 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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