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OpenTrials
Completed

NCT Number: NCT07350525

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Castomize cast

Device

4D castomize cast for distal radius fracture immobilisation

Control

Other

Standard of care casting

Primary outcomes

  1. Fracture reduction

    Time frame: 3 months

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

Secondary outcomes

  1. comfort, pain, itch

    Time frame: 6 months

    Quantitative Likert scoring for comfort, pain, itch as well as qualitative feedback on cast application and comfort.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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