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

Not Applicable

Completed

• Conditions: Humeral Fractures
• Interventions: Procedure: Crossed K-wiring of supracondylar fracture of the humerus; Procedure: Lateral K-wiring of supracondylar fracture of the humerus

• Registration Number: NCT00358787
• Lead Sponsor: University of British Columbia

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 Timeline

• Study First Submitted: 2006-07-28
• Study First Submitted QC: 2006-07-28
• Study First Posted: 2006-08-01
• Study Start: 2008-07
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Crossed K-wiring of supracondylar fracture of the humerus	Crossed K wire orientation for surgical management of a type III Supracondylar fracture.
2	Lateral K-wiring of supracondylar fracture of the humerus	Lateral K wire orientation for surgical management of a type III Supracondylar fracture.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Rate of iatrogenic ulnar nerve injury
Functional outcome (3 years post-op)	3 years

Trial Locations

Locations (1)

British Columbia Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada