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

Tracking Information

• First Submitted Date: July 28, 2006
• First Posted Date: August 1, 2006
• Last Update Posted Date: January 10, 2018
• Study Start Date: July 2008
• Actual Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 28, 2006): Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal)
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 14, 2008)

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

Original Secondary Outcome Measures (submitted: July 28, 2006)

• Functional outcome (3 years post-op)
• Rate of iatrogenic ulnar nerve injury

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
• Procedure: Lateral K-wiring of supracondylar fracture of the humerus
  Closed reduction of the fracture followed by lateral K wire percutaneous pinning.

Study Arms

• Active Comparator: 1
  Crossed K wire orientation for surgical management of a type III Supracondylar fracture.
  Intervention: Procedure: Crossed K-wiring of supracondylar fracture of the humerus
• Active Comparator: 2
  Lateral K wire orientation for surgical management of a type III Supracondylar fracture.
  Intervention: Procedure: Lateral K-wiring of supracondylar fracture of the humerus

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 8, 2018): 55
• Original Enrollment (submitted: July 28, 2006): 42
• Actual Study Completion Date: November 2017
• Actual Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 7 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00358787
• Other Study ID Numbers: H04-70532; W04-0180
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kishore Mulpuri, University of British Columbia
• Study Sponsor: University of British Columbia
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of British Columbia
• Verification Date: January 2018