CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
No Split Cast of forearm fractures +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02614690
NCT02614690N/ACompleted
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Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?

Connecticut Children's Medical Center·interventional·Posted Nov 25, 2015·Updated Jan 14, 2022

In Brief

A clinical study evaluating No Split Cast of forearm fractures, Univalve Split Cast of forearm fractures, and 1 other intervention for Fracture of Shaft of Radius and/or Ulna and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFracture of Shaft of Radius and/or Ulna, Metaphyseal Fracture of Bone of Upper Limb, Fracture of Upper Limb, Level Unspecified
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2015
Enrollment StartJan 1, 2013
Primary CompletionSep 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.6 years ago

Interventions

No Split Cast of forearm fracturesprocedure

Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "No Split Cast" will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.

Univalve Split Cast of forearm fracturesprocedure

Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "Univalve Cast" will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.

Bivalve Split Cast of forearm fracturesprocedure

Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "Bivalve Cast" will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.