An interventional study of Crossed K-wiring of supracondylar fracture of the humerus and Lateral K-wiring of supracondylar fracture of the humerus in Humeral Fractures, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 55 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Crossed K wire orientation for surgical management of a type III Supracondylar fracture.
Procedure: Crossed K-wiring of supracondylar fracture of the humerus
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 crossed K wire percutaneous pinning.
Closed reduction of the fracture followed by lateral K wire percutaneous pinning.
Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal)
Functional outcome (3 years post-op)
Time frame: 3 years
Rate of iatrogenic ulnar nerve injury
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of British Columbia