CASTomize 4D Printed Cast Versus Fibreglass Casts for Distal Radius Fractures

January 10, 2026 updated by: YAM GUI JIE MICHAEL, Tan Tock Seng Hospital
This study is a randomised control trial comparing Castomize 4D printed cast versus conventional fibreglass casts in isolated conservatively treated distal radius fractures. The primary outcome measure is fracture reduction. Secondary outcome measures include patient reported outcome measures such as the Adult Rated Cast Evaluation Questionnaire (ARCEQ), comfort of the cast, quality of life assessed with the EQ-5D-5L questionnaire, cost-effectiveness and adverse events occurrence. In total, 30 patients will be included and followed for 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - Age ≥ 21 years
  • Distal radius fracture for conservative treatment within 3 weeks of initial injury

Exclusion Criteria:

  • Concomitant injuries to the ipsilateral extremity, interfering with the treatment of the DRF (Example: concomitant elbow fracture that requires further immobilisation with a above elbow cast)
  • Inability to complete study forms due to any cognitive, mental issues.
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Standard of care cast
Other: Control
Standard of care casting
Experimental: Intervention
Castomize cast arm
Device: Castomize cast
4D castomize cast for distal radius fracture immobilisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture reduction
Time Frame: 3 months
Fracture alignment is determined by length rotation and angulation in clinically acceptable values as determined by surgical team
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comfort, pain, itch
Time Frame: 6 months
Quantitative Likert scoring for comfort, pain, itch as well as qualitative feedback on cast application and comfort.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

December 25, 2025

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

January 10, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/00073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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