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

This study is currently recruiting participants.
Verified May 2016 by University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT00358787
First Posted: August 1, 2006
Last Update Posted: June 1, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
  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
Intervention Model: Parallel Assignment
Masking: None (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)

Secondary Outcome Measures:
  • Functional outcome (3 years post-op) [ Time Frame: 3 years ]
  • Rate of iatrogenic ulnar nerve injury

Estimated Enrollment: 42
Study Start Date: July 2008
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00358787     History of Changes
Other Study ID Numbers: H04-70532
W04-0180
First Submitted: July 28, 2006
First Posted: August 1, 2006
Last Update Posted: June 1, 2016
Last Verified: May 2016

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
Wounds and Injuries
Arm Injuries