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
  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:


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


Secondary Outcome Measures:
  • 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.


Enrollment: 202
Study Start Date: January 2009
Study Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Associate Professor of Orthopaedic Surgery, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00823823     History of Changes
Other Study ID Numbers: 08-09-0430
Study First Received: January 15, 2009
Results First Received: September 2, 2014
Last Updated: September 2, 2014
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 October 21, 2014