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OpenTrials
Completed

NCT Number: NCT01101607

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

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.

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lebonheur Medical Center

Memphis, Tennessee, 38103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Distal Forearm Fracture Reduction

Procedure

Fracture reduction

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

InMotion Orthopaedic Research Center

Other

Collaborators

  • Campbell Clinic
  • Le Bonheur Children's Hospital
  • University of Tennessee

Registry information

Official study title

Closed Reduction and Cast Immobilization of Distal Radius Fractures by Pediatric Emergency Medicine

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 12, 2010
Registry last updated
Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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