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Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00358787
First received: July 28, 2006
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

Completely displaced (Type III) supracondylar fractures of the humerus are treated in the operating room and are held together with pins stuck into the bone. There are two ways of inserting the pins: crossed and laterally. The crossed method is often used because it is thought to be more stable, but this method also carries a risk of hitting the ulnar nerve. It is not known which method is more stable. Our hypothesis is that loss of reduction will be equivalent between the two pinning methods.


Condition Intervention
Humeral Fractures
Procedure: Crossed K-wiring of supracondylar fracture of the humerus
Procedure: Lateral K-wiring of supracondylar fracture of the humerus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcome (3 years post-op) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Rate of iatrogenic ulnar nerve injury [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: July 2008
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Crossed K wire orientation for surgical management of a type III Supracondylar fracture.
Procedure: Crossed K-wiring of supracondylar fracture of the humerus
Closed reduction of the fracture followed by crossed K wire percutaneous pinning.
Active Comparator: 2
Lateral K wire orientation for surgical management of a type III Supracondylar fracture.
Procedure: Lateral K-wiring of supracondylar fracture of the humerus
Closed reduction of the fracture followed by lateral K wire percutaneous pinning.

Detailed Description:

Children with type III supracondylar fractures of humerus who meet the study inclusion criteria will be invited to participate in the study by the on call orthopaedic surgeon. All patients will be required to provide informed consent. Patients will then be randomized through a random number software package and will commence immediately after confirmation of inclusion into the study. The fracture is reduced and fixed percutaneously either with crossed or lateral K wires, according to which group the subject was randomized to. Post reduction antero-posterior and lateral radiographs of the elbow are done in the operating room. Above elbow cast is applied. Radiographs are taken at follow-up visits to the clinic. The radiographs are measured to determine loss of reduction between immediate post-op films and films taken immediately prior to pin removal.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients scheduled for closed reduction and K wiring of supracondylar fractures of the humerus under general anaesthesia a
  • Type-3 Supracondylar fractures of the humerus.
  • Aged 3 to 7 years old
  • Consent to participate in the study

Exclusion Criteria:

  • Open supracondylar fractures of the humerus
  • Children with pre-operative ulnar nerve injury
  • Supracondylar fractures with compartment syndrome needing fasciotomy
  • Supracondylar fractures needing vascular repair
  • Refusal to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358787

Contacts
Contact: Janice Andrade 604-875-2359 janice.andrade@cw.bc.ca

Locations
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Principal Investigator: Kishore Mulpuri, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kishore Mulpuri, MD The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00358787     History of Changes
Other Study ID Numbers: H04-70532, W04-0180
Study First Received: July 28, 2006
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Supracondylar fracture
humerus
ulnar nerve injury
Baumann's angle
Supracondylar fracture of the humerus

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014