N/A
N=216
Randomized Trial of Casting Techniques for Displaced Forearm Fractures
Displaced Forearm Fractures
Bottom Line
View on ClinicalTrials.gov: NCT00823823 ↗Enrolled (actual)
216
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Loss of Radius Fracture Reduction — 35; 35; 66; 66 participants — p=1.00
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bivalved cast (Other); Circumferential cast (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Loss of Radius Fracture Reduction |
35; 35; 66; 66 | 1.00 |
| SECONDARY Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations |
0; 0; 0; 0; 0; 0 | — |
Summary
It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.
Eligibility Criteria
Inclusion Criteria
- Displaced distal radius or mid-diaphyseal forearm fracture
- fracture requires closed reduction and cast immobilization
- Age 4-16 years
- Skeletally immature
Exclusion Criteria
- Failed closed reduction
- Acute fracture > 1 week old
- Refracture injury
- Fracture requires surgical treatment
- Significant soft tissue swelling
- Associated neurovascular compromise
- Plastic deformation injuries
Data sourced from ClinicalTrials.gov (NCT00823823). 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.