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

NCT ID: NCT00358787

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2017-11-30

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.

Conditions

Humeral Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Crossed K wire orientation for surgical management of a type III Supracondylar fracture.

Group Type: ACTIVE_COMPARATOR

Crossed K-wiring of supracondylar fracture of the humerus

Intervention Type: PROCEDURE

Closed reduction of the fracture followed by crossed K wire percutaneous pinning.

2

Lateral K wire orientation for surgical management of a type III Supracondylar fracture.

Group Type: ACTIVE_COMPARATOR

Lateral K-wiring of supracondylar fracture of the humerus

Intervention Type: PROCEDURE

Closed reduction of the fracture followed by lateral K wire percutaneous pinning.

Interventions

Crossed K-wiring of supracondylar fracture of the humerus

Closed reduction of the fracture followed by crossed K wire percutaneous pinning.

Intervention Type: PROCEDURE

Lateral K-wiring of supracondylar fracture of the humerus

Closed reduction of the fracture followed by lateral K wire percutaneous pinning.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kishore Mulpuri

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kishore Mulpuri, MD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

W04-0180

Identifier Type: -

Identifier Source: secondary_id

H04-70532

Identifier Type: -

Identifier Source: org_study_id