Clinical trial NCT02614690: Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?
Official title: Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture of Shaft of Radius and/or Ulna
Metaphyseal Fracture of Bone of Upper Limb
Fracture of Upper Limb, Level Unspecified
Keywords: Fracture of the upper limb
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. Theoretically, the splitting of the cast allows for expansion and soft tissue swelling. However, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a cast. In a study by Nietosvaara et. al, a retrospective examination of 109 pediatric patients initially treated with closed cylindrical casting for closed forearm fractures were evaluated. Of these 109 patients, one-sixth required the initial cast to be split, trimmed, or removed secondary to post-traumatic swelling.

However, the splitting of a cast is not without risks in itself. Once the initial swelling dissipates, a univalved or bivalved cast can become excessively loose. This loosening has been associated with a loss of reduction. If the loss or reduction is substantial, it may require a re-reduction or operation to correct. In addition, with every use of the cast saw a patient is placed at risk for iatrogenic cast saw injury. Thermal burns and abrasions from cast saws can cause lifelong emotional and physical scars for a patient. They can also be an inciting event for litigation against the hospital and or provider, with settlements averaging greater than $12,000 per centimeter of cast saw injury.

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:

1. 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
2. Generic exclusion: "Subjects not meeting all inclusion criteria."

Primary outcomes:
measure: Complication Rate of the Cast Type
timeFrame: <60 days corresponding to total study time and consistent with outcome 6
Secondary outcomes:
Other outcomes:
measure: Cast Index
timeFrame: Immediately after cast application (<1 day)
measure: Number of Participants With Different Fracture Characteristics
timeFrame: Less than 1 day
measure: Pain Levels
timeFrame: one week
measure: Number of Patients With Different Fracture Treatments
timeFrame: 4 weeks
measure: Number of Participants With Different Cast Complications
timeFrame: Day 1 to day 56
measure: Average Time for First Follow-up Appointment
timeFrame: 1-2 weeks
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Mark Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: