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Randomized Trial of Casting Techniques for Displaced Forearm Fractures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00823823
First received: January 15, 2009
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Displaced Forearm Fractures
 Other: Bivalved cast
Other: Circumferential cast

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Loss of radius fracture reduction [ Time Frame: 4 weeks post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compartment syndrome or neurovascular compromise, Saw burns and/or lacerations [ Time Frame: 4 weeks post-randomization ] [ Designated as safety issue: Yes ]

Enrollment: 224
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Other: Bivalved cast
Circumferential cast will be applied following closed reduction and then bivalved using a cast saw
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
 Other: Circumferential cast
Circumferential cast will be applied following closed reduction

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823823

Locations
United States, Massachusetts
Childrens Hospital Boston
Boston, Massachusetts, United States, 02125
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Donald Bae, MD Childrens Hospital Boston
  More Information

No publications provided

Responsible Party: Donald Bae, MD, Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT00823823     History of Changes
Other Study ID Numbers: 08-09-0430
Study First Received: January 15, 2009
Last Updated: July 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Casting techniques
Bivalved cast
Circumferential cast
Displaced distal radius fracture
Children

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013