An interventional study of Distal Forearm Fracture Reduction in Pediatric Distal Forearm Fractures, sponsored by InMotion Orthopaedic Research Center. Completed at 1 site in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2010-04-12.
Sponsored by InMotion Orthopaedic Research Center · Not applicable, Interventional, and Health services research
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.
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 104 is below the median of 145 across 931 interventional studies indexed under Emergencies.
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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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Patients randomized to Pediatric Emergency Physician Group will have their fracture reduced by a Pediatric Emergency Physician
Procedure: Distal Forearm Fracture Reduction
Patients to be randomized to Orthopaedic physician Group will have their fracture reduced by an Orthopaedic Physician
Procedure: Distal Forearm Fracture Reduction
Fracture reduction
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.
Time frame: 5-7 days post-injury
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.
Time frame: 6-8 weeks post-injury
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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