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Randomized Trial of Casting Techniques for Displaced Forearm Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donald Bae, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00823823
First received: January 15, 2009
Last updated: September 2, 2014
Last verified: September 2014

January 15, 2009
September 2, 2014
January 2009
June 2011   (final data collection date for primary outcome measure)
Loss of Radius Fracture Reduction [ Time Frame: 4 weeks post-randomization ] [ Designated as safety issue: No ]
The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.
Loss of radius fracture reduction [ Time Frame: 4 weeks post-randomization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00823823 on ClinicalTrials.gov Archive Site
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations [ Time Frame: Up to 4 weeks post-randomization ] [ Designated as safety issue: Yes ]
The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.
Compartment syndrome or neurovascular compromise, Saw burns and/or lacerations [ Time Frame: 4 weeks post-randomization ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Randomized Trial of Casting Techniques for Displaced Forearm Fractures
Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Displaced Forearm Fractures
  • Other: Bivalved cast
    Circumferential cast will be applied following closed reduction and then bivalved using a cast saw
  • Other: Circumferential cast
    Circumferential cast will be applied following closed reduction
  • Active Comparator: Bivalved cast
    Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
    Intervention: Other: Bivalved cast
  • Active Comparator: Circumferential cast
    Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
    Intervention: Other: Circumferential cast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
August 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
4 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823823
08-09-0430
Yes
Donald Bae, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Donald Bae, MD Childrens Hospital Boston
Children's Hospital Boston
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP