Distal Radius Fracture
Conditions
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.
Interventions
DEVICECastomize cast
4D castomize cast for distal radius fracture immobilisation
OTHERControl
Standard of care casting
Sponsors
Tan Tock Seng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fracture reduction | 3 months | Fracture alignment is determined by length rotation and angulation in clinically acceptable values as determined by surgical team |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comfort, pain, itch | 6 months | Quantitative Likert scoring for comfort, pain, itch as well as qualitative feedback on cast application and comfort. |
Countries
Singapore
Outcome results
None listed