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

Primary Purpose

Pediatric Distal Forearm Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Distal Forearm Fracture Reduction
Sponsored by
InMotion Orthopaedic Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pediatric Distal Forearm Fractures focused on measuring Pediatrics, Distal Forearm fractures, Pediatric Emergency Medicine, Pediatric Orthopedics

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Lebonheur Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pediatric Emergency Physician

Orthopaedic physician

Arm Description

Patients randomized to Pediatric Emergency Physician Group will have their fracture reduced by a Pediatric Emergency Physician

Patients to be randomized to Orthopaedic physician Group will have their fracture reduced by an Orthopaedic Physician

Outcomes

Primary Outcome Measures

Adequate Alignment of the forearm fracture
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
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.

Full Information

First Posted
April 8, 2010
Last Updated
April 8, 2010
Sponsor
InMotion Orthopaedic Research Center
Collaborators
University of Tennessee, Le Bonheur Children's Hospital, Campbell Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01101607
Brief Title
Closed Reduction of Distal Forearm Fractures by Pediatric Emergency Medicine Physicians: A Prospective Study
Official Title
Closed Reduction and Cast Immobilization of Distal Radius Fractures by Pediatric Emergency Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
InMotion Orthopaedic Research Center
Collaborators
University of Tennessee, Le Bonheur Children's Hospital, Campbell Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Distal Forearm Fractures
Keywords
Pediatrics, Distal Forearm fractures, Pediatric Emergency Medicine, Pediatric Orthopedics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pediatric Emergency Physician
Arm Type
Active Comparator
Arm Description
Patients randomized to Pediatric Emergency Physician Group will have their fracture reduced by a Pediatric Emergency Physician
Arm Title
Orthopaedic physician
Arm Type
Active Comparator
Arm Description
Patients to be randomized to Orthopaedic physician Group will have their fracture reduced by an Orthopaedic Physician
Intervention Type
Procedure
Intervention Name(s)
Distal Forearm Fracture Reduction
Intervention Description
Fracture reduction
Primary Outcome Measure Information:
Title
Adequate Alignment of the forearm fracture
Description
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.
Time Frame
5-7 days post-injury
Secondary Outcome Measure Information:
Title
Complications
Description
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.
Time Frame
6-8 weeks post-injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Pershad, MD
Organizational Affiliation
University of Tennessee Health Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shehma Khan, MD
Organizational Affiliation
University of Tennessee Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lebonheur Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19034167
Citation
Ward WT, Eberson CP, Otis SA, Wallace CD, Wellisch M, Warman JR, Leitch KK, Epps HR, Richards BS. Pediatric orthopaedic practice management: the role of midlevel providers. J Pediatr Orthop. 2008 Dec;28(8):795-8. doi: 10.1097/BPO.0b013e318183249f. No abstract available.
Results Reference
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PubMed Identifier
18209607
Citation
Ward WT, Rihn JA. Demographic and financial implications of pediatric emergency department fracture manipulation. J Pediatr Orthop. 2007 Dec;27(8):877-81. doi: 10.1097/BPO.0b013e3181558c4d.
Results Reference
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PubMed Identifier
19201136
Citation
Pershad J, Williams S, Wan J, Sawyer JR. Pediatric distal radial fractures treated by emergency physicians. J Emerg Med. 2009 Oct;37(3):341-4. doi: 10.1016/j.jemermed.2008.08.030. Epub 2009 Feb 6.
Results Reference
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Closed Reduction of Distal Forearm Fractures by Pediatric Emergency Medicine Physicians: A Prospective Study

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