N/A
N=60
Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?
Fracture of Shaft of Radius and/or Ulna · Metaphyseal Fracture of Bone of Upper Limb · Fracture of Upper Limb, Level Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT02614690 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Complication Rate of the Cast Type — 9; 12; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- No Split Cast of forearm fractures (Procedure); Univalve Split Cast of forearm fractures (Procedure); Bivalve Split Cast of forearm fractures (Procedure)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Connecticut Children's Medical Center
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication Rate of the Cast Type |
9; 12; 8 | — |
Summary
This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.
Eligibility Criteria
Inclusion Criteria
- A closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures.
- Forearm fractures that require closed reduction (with or without conscious sedation)
- Patients between the ages of 3 and 12 years old
Exclusion Criteria
- Specific exclusions
- Age less than 3 or greater than 12
- Patients presenting with an associated neurological or vascular injury caused by the fracture
- Patients presenting with an open fracture
- Patients requiring operative treatment following the initial fracture evaluation
- Ipsilateral upper extremity fracture
- Patients intubated or with a pre-existing condition that prevents them from verbalizing symptoms of discomfort
- Generic exclusion: "Subjects not meeting all inclusion criteria."
Data sourced from ClinicalTrials.gov (NCT02614690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.