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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
Results First Received: September 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Displaced Forearm Fractures
Interventions: Other: Bivalved cast
Other: Circumferential cast

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bivalved Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
Circumferential Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast

Participant Flow:   Overall Study
    Bivalved Cast     Circumferential Cast  
STARTED     109     107  
COMPLETED     101     101  
NOT COMPLETED     8     6  
Lost to Follow-up                 3                 1  
Protocol Violation                 5                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Bivalved Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
Circumferential Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
Total Total of all reporting groups

Baseline Measures
    Bivalved Cast     Circumferential Cast     Total  
Number of Participants  
[units: participants]
  101     101     202  
Age  
[units: participants]
     
<=18 years     101     101     202  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  9  ± 6     10  ± 6     10  ± 3  
Gender  
[units: participants]
     
Female     34     33     67  
Male     67     68     135  
Region of Enrollment  
[units: participants]
     
United States     101     101     202  



  Outcome Measures
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1.  Primary:   Loss of Radius Fracture Reduction   [ Time Frame: 4 weeks post-randomization ]

2.  Secondary:   Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations   [ Time Frame: Up to 4 weeks post-randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Donald Bae
Organization: Children's Hospital Boston
phone: 617-355-6808
e-mail: donald.bae@childrens.harvard.edu


No publications provided


Responsible Party: Donald Bae, 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