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

Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Humeral Fractures
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • British Columbia Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure	Time Frame
Functional outcome (3 years post-op)	3 years
Rate of iatrogenic ulnar nerve injury

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Kishore Mulpuri, MD, The University of British Columbia

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: July 28, 2006
• First Submitted That Met QC Criteria: July 28, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: humerus; Supracondylar fracture; ulnar nerve injury; Baumann's angle; Supracondylar fracture of the humerus
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: H04-70532; W04-0180