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

Sponsor
InMotion Orthopaedic Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT01101607
Collaborator
University of Tennessee Health Science Center (Other), Le Bonheur Children's Hospital (Other), Campbell Clinic (Other)
104
1
2
24
4.3

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Distal Forearm Fracture Reduction
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Health Services Research
Official Title:
Closed Reduction and Cast Immobilization of Distal Radius Fractures by Pediatric Emergency Medicine
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Adequate Alignment of the forearm fracture [5-7 days post-injury]

    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

  1. Complications [6-8 weeks post-injury]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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 Hospital
  • Campbell Clinic

Investigators

  • Study Director: Jay Pershad, MD, University of Tennessee Health Sciences
  • Principal Investigator: Shehma Khan, MD, University of Tennessee Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01101607
Other Study ID Numbers:
  • MHIRB 2008-006
First Posted:
Apr 12, 2010
Last Update Posted:
Apr 12, 2010
Last Verified:
Apr 1, 2010

Study Results

No Results Posted as of Apr 12, 2010