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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358787
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Kishore Mulpuri, University of British Columbia

Tracking Information
First Submitted Date  ICMJE July 28, 2006
First Posted Date  ICMJE August 1, 2006
Last Update Posted Date January 10, 2018
Study Start Date  ICMJE July 2008
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2006)
Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
  • Functional outcome (3 years post-op) [ Time Frame: 3 years ]
  • Rate of iatrogenic ulnar nerve injury
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2006)
  • Functional outcome (3 years post-op)
  • Rate of iatrogenic ulnar nerve injury
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires
Official Title  ICMJE Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Humeral Fractures
Intervention  ICMJE
  • Procedure: Crossed K-wiring of supracondylar fracture of the humerus
    Closed reduction of the fracture followed by crossed K wire percutaneous pinning.
  • Procedure: Lateral K-wiring of supracondylar fracture of the humerus
    Closed reduction of the fracture followed by lateral K wire percutaneous pinning.
Study Arms  ICMJE
  • Active Comparator: 1
    Crossed K wire orientation for surgical management of a type III Supracondylar fracture.
    Intervention: Procedure: Crossed K-wiring of supracondylar fracture of the humerus
  • Active Comparator: 2
    Lateral K wire orientation for surgical management of a type III Supracondylar fracture.
    Intervention: Procedure: Lateral K-wiring of supracondylar fracture of the humerus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2018)
55
Original Enrollment  ICMJE
 (submitted: July 28, 2006)
42
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00358787
Other Study ID Numbers  ICMJE H04-70532
W04-0180
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kishore Mulpuri, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kishore Mulpuri, MD The University of British Columbia
PRS Account University of British Columbia
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP