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

Tan Tock Seng Hospital

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Other: Control; Device: Castomize cast

Study type: Interventional

Funder types: Other

Identifiers

NCT07350525

2024/00073

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Control

Other group

Description:

Standard of care cast

Treatment:

Other: Control

Intervention

Experimental group

Description:

Castomize cast arm

Treatment:

Device: Castomize cast