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OpenTrials
Completed

NCT Number: NCT00823823

Randomized Trial of Casting Techniques for Displaced Forearm Fractures

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.

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Key information

Conditions

Displaced Forearm Fractures

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Hospital Boston

Boston, Massachusetts, 02125, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bivalved cast

Other

Circumferential cast will be applied following closed reduction and then bivalved using a cast saw

Circumferential cast

Other

Circumferential cast will be applied following closed reduction

Primary outcomes

  1. Loss of Radius Fracture Reduction

    Time frame: 4 weeks post-randomization

    The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.

Secondary outcomes

  1. Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations

    Time frame: Up to 4 weeks post-randomization

    The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 16, 2009
Registry last updated
Sep 9, 2014

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.