Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures (NCT05716438) | Clinical Trial Compass
CompletedNot Applicable
Prospective Evaluation of Cast Bivalving for Pediatric Distal Radius Fractures
United States60 participantsStarted 2019-03-01
Plain-language summary
Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. However, this can compromise the casts' structural integrity, predisposing fractures to loss of reduction. The goal of this study was to investigate if cast bivalving, or splitting the cast longitudinally on both sides, resulted in any immediate change to bony alignment and to assess if bivalving effected cast parameters associated with loss of reduction.
Who can participate
Age range
1 Year – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Guardian must be present
* Able/eligible to complete follow-up
* Initial injury within 72 hours
* Distal Radius fracture with or without distal ulna fracture
* Requiring non-operative management with molded cast
Exclusion Criteria:
* Open fractures
* Re-fractures
* Pathologic fractures
* Fractures associated with neurovascular injury
* Poly trauma incident
* Intubated patients or unable to verbalize symptoms of pain
* Preexisting medical history that effects musculoskeletal health
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in reduction after bivalving
Timeframe: up to 24 hours
2
Change in reduction at follow-up
Timeframe: up to 30 days
3
Cast Index
Timeframe: through study completion, up to 2 years
4
Gap Index
Timeframe: through study completion, up to 2 years
5
Three Point Index
Timeframe: through study completion, up to 2 years