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Closed Reduction of Distal Forearm Fractures by Pediatric Emergency Medicine Physicians: A Prospective Study

This study has been completed.
Sponsor:
Collaborators:
University of Tennessee Health Science Center
Le Bonheur Children's Medical Center
Campbell Clinic
Information provided by:
InMotion Orthopaedic Research Center
ClinicalTrials.gov Identifier:
NCT01101607
First received: April 8, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

Distal forearm fractures are amongst the most frequently encountered orthopedic injuries in the pediatric emergency department (ED). Immediate closed manipulation and cast immobilization, is still the mainstay of management. The initial management of non-displaced or minimally displaced extremity fractures and relocation of uncomplicated joint dislocations is part of the usual practice of emergency medicine. Although focused training in fracture-dislocation reduction techniques is a part of the core curriculum of emergency medicine training programs, there is limited data discussing outcomes following restorative fracture care by pediatric emergency medicine (PEM)physicians.

The primary objective of this study is to compare length-of-stay and clinical outcomes after closed manipulation of uncomplicated, isolated, distal forearm fractures, by PEMs to those after manipulation by pediatric orthopedic surgeons. Our hypothesis is that there is no difference in emergency department length-of-stay when fracture reduction is performed by a PEM versus a post graduate year 3 or 4 orthopedic resident. Secondary outcomes that will be assessed include: loss of reduction needing re-manipulation at follow up, cast related complications, radiographic and functional healing at 6-8 weeks post injury.


Condition Intervention
Pediatric Distal Forearm Fractures
Procedure: Distal Forearm Fracture Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Closed Reduction and Cast Immobilization of Distal Radius Fractures by Pediatric Emergency Medicine

Resource links provided by NLM:


Further study details as provided by InMotion Orthopaedic Research Center:

Primary Outcome Measures:
  • Adequate Alignment of the forearm fracture [ Time Frame: 5-7 days post-injury ] [ Designated as safety issue: No ]
    The primary outcome in this study is the determination of whether there is adequate alignment of the fracture at 5-7 days post-injury. The proportion of patients with adequate alignments will be compared between the Pediatric Emergency Medicine and the Orthopaedic groups.


Secondary Outcome Measures:
  • Complications [ Time Frame: 6-8 weeks post-injury ] [ Designated as safety issue: Yes ]
    Secondary outcomes to be assessed include incidence of failed apposition needing remanipulation at follow-up, cast-related complications, radiographic and functional healing at 6-8 weeks post-injury, length of stay in the emergency department, and facility charges. Comparisons between the two treatment groups (PEM and OP) will also be made with respect to each of these outcome variables.


Enrollment: 104
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pediatric Emergency Physician
Patients randomized to Pediatric Emergency Physician Group will have their fracture reduced by a Pediatric Emergency Physician
Procedure: Distal Forearm Fracture Reduction
Fracture reduction
Active Comparator: Orthopaedic physician
Patients to be randomized to Orthopaedic physician Group will have their fracture reduced by an Orthopaedic Physician
Procedure: Distal Forearm Fracture Reduction
Fracture reduction

Detailed Description:

Pediatric forearm fractures are common injuries and a frequent cause for an emergency room admission. Ward et al have outlined the demands that emergency department coverage places on practicing orthopedic surgeons. Assuming no statistically significant differences in outcomes, there are potential advantages of having PEMs provide restorative fracture care at the initial visit. This practice would permit judicious orthopedic consultation at a time when several emergency department's are facing an "on call" specialist coverage crisis and there exists a nationwide shortage of fellowship trained pediatric orthopedic specialists, in addition to ACGME mandated duty hour restrictions for orthopedic residents.

Pershad et al conducted a retrospective study with historical controls, of 60 patients with distal radius fracture that were reduced by an orthopedic resident or PEM physician. In this review, there were no differences in rates of re-intervention to restore fracture alignment or ED length-of-stay between the two groups.Mean facility charges were lower in the group treated by PEMs.

It is our hypothesis that with goal directed training, PEM physicians can perform closed reduction of uncomplicated distal forearm fractures with outcomes that are similar to when fracture reduction is performed by senior orthopedic resident physicians.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria will include patients who present to LeBonheur Emergency room with an angulated or displaced distal radius fracture that meet standard orthopaedic criteria for manipulation. Distal forearm will be defined anatomically as the distal third of the radius or ulna.

Exclusion Criteria:

The exclusion criteria will be patients with an open fracture, neurovascular compromise at presentation or who have undergone prior manipulation of their fracture. Prior manipulation of a fracture is defined when a patient has their fracture manipulated at an outlying facility prior to arriving to LeBonhuer emergency room.

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  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: NCT01101607

Locations
United States, Tennessee
Lebonheur Medical Center
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
InMotion Orthopaedic Research Center
University of Tennessee Health Science Center
Le Bonheur Children's Medical Center
Campbell Clinic
Investigators
Study Director: Jay Pershad, MD University of Tennessee Health Sciences
Principal Investigator: Shehma Khan, MD University of Tennessee Health Sciences
  More Information

Publications:
Responsible Party: Dick Tarr, InMotion Orthopaedic Research Center
ClinicalTrials.gov Identifier: NCT01101607     History of Changes
Other Study ID Numbers: MHIRB 2008-006
Study First Received: April 8, 2010
Last Updated: April 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by InMotion Orthopaedic Research Center:
Pediatrics
Distal Forearm fractures
Pediatric Emergency Medicine
Pediatric Orthopedics

Additional relevant MeSH terms:
Emergencies
Fractures, Bone
Disease Attributes
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014