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

NCT01101607 | Completed

• 1 other identifier: MHIRB 2008-006
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Distal Forearm Fractures

Keywords

Pediatrics; Distal Forearm fractures; Pediatric Emergency Medicine; Pediatric Orthopedics

Outcome Measures

Primary Outcomes (1)

• 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.

  5-7 days post-injury

Secondary Outcomes (1)

• Complications

  6-8 weeks post-injury

Study Arms (2)

Pediatric Emergency Physician

ACTIVE COMPARATOR

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

Procedure: Distal Forearm Fracture Reduction

Orthopaedic physician

ACTIVE COMPARATOR

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

Procedure: Distal Forearm Fracture Reduction

Interventions

Distal Forearm Fracture Reduction PROCEDURE

Fracture reduction

Orthopaedic physician; Pediatric Emergency Physician

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• InMotion Orthopaedic Research Center: lead
• University of Tennessee: collaborator
• Le Bonheur Children's Hospital: collaborator
• Campbell Clinic: collaborator

Study Sites (1)

Lebonheur Medical Center

Memphis, Tennessee, 38103, United States

Location

Related Publications (3)

• 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.

  PMID: 19034167 BACKGROUND

• 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.

  PMID: 18209607 BACKGROUND

• 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.

  PMID: 19201136 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Jay Pershad, MD

  University of Tennessee Health Sciences

  STUDY DIRECTOR

• Shehma Khan, MD

  University of Tennessee Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 12, 2010
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: April 1, 2010
• Last Updated: April 12, 2010

Record last verified: 2010-04

Locations

US (1)