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Completed

NCT Number: NCT00358787

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

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.

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Key information

Conditions

Humeral Fractures Arm Injuries Fractures, Bone Wounds and Injuries

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crossed K-wiring of supracondylar fracture of the humerus

Procedure

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

Lateral K-wiring of supracondylar fracture of the humerus

Procedure

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

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

  1. Functional outcome (3 years post-op)

    Time frame: 3 years

  2. Rate of iatrogenic ulnar nerve injury

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2006
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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