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

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ClinicalTrials.gov Identifier: NCT00358787
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
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
Study Start Date : July 2008
Primary Completion Date : November 2017
Study Completion Date : November 2017

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Functional outcome (3 years post-op) [ Time Frame: 3 years ]
  2. Rate of iatrogenic ulnar nerve injury

Eligibility Criteria

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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


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

Responsible Party: Kishore Mulpuri, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00358787     History of Changes
Other Study ID Numbers: H04-70532
W04-0180
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Keywords provided by Kishore Mulpuri, 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