Clinical trial NCT00358787: Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires
Official title: Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humeral Fractures
Keywords: Supracondylar fracture
humerus
ulnar nerve injury
Baumann's angle
Supracondylar fracture of the humerus
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2006-08-01
Enrollment: 55
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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:
measure: Functional outcome (3 years post-op)
timeFrame: 3 years
measure: Rate of iatrogenic ulnar nerve injury
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Kishore Mulpuri, MD
role: PRINCIPAL_INVESTIGATOR
References: