When children up to 11 years old break the bones in their wrists, do they need surgery to perfectly realign the bones, or will nature 'self-correct' the bones as they heal without restricting the use of the arm?
- Conditions
- Radius acute fractureInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN10931294
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 750
1. Male and female children aged 4 to 10 years inclusive
2. Parents/guardians willing and able to give informed consent for their child’s participation in the study
3. There is radiographic evidence of a severely displaced wrist fracture at or adjacent to the physis (Salter-Harris II or a metaphyseal fracture); with or without a corresponding ulna fracture
4. The treating clinician believes that they may benefit from surgical reduction with or without fixation
1. The injury is more than 7 days old
2. The injury is part of a more complex wrist fracture (i.e. open or fracture extending into the joint)
3. There are other fractured bones elsewhere in the body, in addition to the affected wrist injury
4. There is evidence that the patient and/or parent would be unable to adhere to trial procedures or complete follow-up, such as insufficient English language comprehension, developmental delay or a developmental abnormality or no access by parents to mobile data/internet
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional recovery assessed using the Patient Report Outcomes Measurement System (PROMIS Bank v2.0) Upper Extremity Score for Children Computer Adaptive Test (CAT) at 3 months post-treatment
- Secondary Outcome Measures
Name Time Method