NCT07350525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

December 31, 2025

Last Update Submit

January 10, 2026

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • Fracture reduction

    Fracture alignment is determined by length rotation and angulation in clinically acceptable values as determined by surgical team

    3 months

Secondary Outcomes (1)

  • comfort, pain, itch

    6 months

Study Arms (2)

Control

OTHER

Standard of care cast

Other: Control

Intervention

EXPERIMENTAL

Castomize cast arm

Device: Castomize cast

Interventions

Castomize castDEVICE

4D castomize cast for distal radius fracture immobilisation

Intervention
ControlOTHER

Standard of care casting

Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 20, 2026

Study Start

January 14, 2024

Primary Completion

June 1, 2025

Study Completion

December 25, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)