Closed Reduction of Distal Forearm Fractures by Pediatric Emergency Medicine Physicians: A Prospective Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01101607|
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : April 12, 2010
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|
|Pediatric Distal Forearm Fractures||Procedure: Distal Forearm Fracture Reduction||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Closed Reduction and Cast Immobilization of Distal Radius Fractures by Pediatric Emergency Medicine|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||April 2010|
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
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
- Adequate Alignment of the forearm fracture [ Time Frame: 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.
- Complications [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101607
|United States, Tennessee|
|Lebonheur Medical Center|
|Memphis, Tennessee, United States, 38103|
|Study Director:||Jay Pershad, MD||University of Tennessee Health Sciences|
|Principal Investigator:||Shehma Khan, MD||University of Tennessee Health Sciences|