Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-Wires - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00358787

Purpose

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	Intervention
Humeral Fractures	Procedure: Crossed K-wiring of supracondylar fracture of the humerus Procedure: Lateral K-wiring of supracondylar fracture of the humerus

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Management of Displaced Supracondylar Fractures of the Humerus Using Lateral Versus Cross K Wires: A Prospective Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Loss of reduction between lateral K wires and crossed K wires in the treatment of supracondylar fractures of the humerus (at pin removal) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional outcome (3 years post-op) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Rate of iatrogenic ulnar nerve injury [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Supracondylar fracture of the humerus will be reduced and fixed percutaneously with crossed K wires.	Procedure: Crossed K-wiring of supracondylar fracture of the humerus The fracture will be reduced and fixed percutaneously with crossed K wires.
2: Active Comparator Supracondylar fracture of the humerus will be reduced and fixed percutaneously with lateral K wires.	Procedure: Lateral K-wiring of supracondylar fracture of the humerus The fracture will be reduced and fixed percutaneously with lateral K wires.

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

Ages Eligible for Study:	3 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358787

Contacts

Contact: Bronwyn Tritt

604-875-2359

btritt@cw.bc.ca

Locations

Canada, British Columbia
British Columbia Children's Hospital	Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Bronwyn Tritt 604-875-2359 btritt@cw.bc.ca
Principal Investigator: Kishore Mulpuri, MD

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Kishore Mulpuri, MD

The University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. Kishore Mulpuri )
Study ID Numbers:	C04-0532, W04-0180
Study First Received:	July 28, 2006
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00358787 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

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

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Humeral Fractures
Arm Injuries

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Humeral Fractures
Arm Injuries

ClinicalTrials.gov processed this record on July 02, 2009