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

NCT00358787 | Completed

• 2 other identifiers: H04-70532W04-0180
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Humeral Fractures

Keywords

Supracondylar fracture; humerus; ulnar nerve injury; Baumann's angle; Supracondylar fracture of the humerus

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• Functional outcome (3 years post-op)

  3 years

• Rate of iatrogenic ulnar nerve injury

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: Crossed K-wiring of supracondylar fracture of the humerus

2

ACTIVE COMPARATOR

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

Procedure: Lateral K-wiring of supracondylar fracture of the humerus

Interventions

Crossed K-wiring of supracondylar fracture of the humerus PROCEDURE

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

1

Lateral K-wiring of supracondylar fracture of the humerus PROCEDURE

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

2

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Kishore Mulpuri, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: July 1, 2008
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

CA (1)