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Completed

NCT Number: NCT02614690

Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?

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.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

No Split Cast of forearm fractures

Procedure

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 fractures

Procedure

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 fractures

Procedure

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.

Primary outcomes

  1. Complication Rate of the Cast Type

    Time frame: <60 days corresponding to total study time and consistent with outcome 6

    This data will be able to help physicians and ER personnel help this patient population with the least number of cast complications and therefore allow for a more efficient use of resources since cast modifications could be minimized. Metrics used to characterize complications are the radiographic union used to determine speed of healing and the number of unplanned ER or clinic visits for cast modifications.

Other outcomes

  1. Cast Index

    Time frame: Immediately after cast application (<1 day)

    The cast index is a measure of potential for cast failure described by Chess et al. in 1994. The cast index is calculated as the sagittal width measure divided by the coronal cast width measure at the fracture site. A ratio between these measures of 0.7 or greater for pediatric forearms is considered acceptable. For each patient in this study the cast index was calculated as described above. The average cast index for each of the 3 groups was then presented as the final result.

  2. Number of Participants With Different Fracture Characteristics

    Time frame: Less than 1 day

  3. Pain Levels

    Time frame: one week

    Pain levels were assessed using the validated Wong-Baker FACES visual pain rating scale. This scale presents a total of 6 options for pain- none, 1, 2, 3, 4, and 5- with 5 corresponding to the greatest amount of pain. During the analysis it was decided to group these into 5 categories: No pain which was equal to those selecting none, Mild corresponding to those selecting 1, Moderate pain corresponding to those that selected either 2 or 3, and Severe pain corresponding to those that selected either 4 or 5. Patients with no response were placed into the group "no response".

  4. Number of Patients With Different Fracture Treatments

    Time frame: 4 weeks

  5. Number of Participants With Different Cast Complications

    Time frame: Day 1 to day 56

  6. Average Time for First Follow-up Appointment

    Time frame: 1-2 weeks

    Average time from reduction and casting to the first follow-up visit.

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2015
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.