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

Humeral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358787
• Other study ID #: H04-70532
• Secondary ID: W04-0180
• Status: Completed
• Phase: N/A
• First received: July 28, 2006
• Last updated: January 8, 2018
• Start date: July 2008
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

Intervention

Procedure:
• Crossed K-wiring of supracondylar fracture of the humerus
Closed reduction of the fracture followed by crossed K wire percutaneous pinning.
• Lateral K-wiring of supracondylar fracture of the humerus
Closed reduction of the fracture followed by lateral K wire percutaneous pinning.

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal)
Secondary	Functional outcome (3 years post-op)		3 years
Secondary	Rate of iatrogenic ulnar nerve injury