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

• ClinicalTrials.gov Identifier: NCT00358787
• Recruitment Status: Completed
• First Posted: August 1, 2006
• Last Update Posted: January 10, 2018
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): Kishore Mulpuri, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Humeral Fractures	Procedure: Crossed K-wiring of supracondylar fracture of the humerus; Procedure: Lateral K-wiring of supracondylar fracture of the humerus	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial
• Study Start Date: July 2008
• Actual Primary Completion Date: November 2017
• Actual Study Completion Date: November 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Functional outcome (3 years post-op) [ Time Frame: 3 years ]
2. Rate of iatrogenic ulnar nerve injury

Eligibility Criteria

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

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

Contacts and Locations

Locations

Canada, British Columbia

British Columbia Children's Hospital

Vancouver, British Columbia, Canada, V6H 3V4

Sponsors and Collaborators

University of British Columbia

Investigators

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

More Information

• Responsible Party: Kishore Mulpuri, Principle Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT00358787
• Other Study ID Numbers: H04-70532; W04-0180
• First Posted: August 1, 2006
• Last Update Posted: January 10, 2018
• Last Verified: January 2018

Keywords provided by Kishore Mulpuri, University of British Columbia:

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

Additional relevant MeSH terms:

Fractures, Bone; Humeral Fractures; Wounds and Injuries; Arm Injuries