Type II Supracondylar Fractures in Children

Withdrawn before enrolling

Conditions studied: Type II Supracondylar Fractures

In brief

Supracondylar fractures are the most common elbow fractures in children. In the current orthopedic literature crossed pinning and lateral-only entry techniques are co-gold standards of operative treatment. The crossed pinning technique has been shown to be biomechanically superior especially under torsional loading but has a higher incidence of iatrogenic injury to the ulnar nerve. All studies comparing these techniques to date have been either biomechanical or retrospective in nature. A randomized, controlled, prospective study comparing these two popular techniques has not been performed. The purpose of this study is to prospectively evaluate the amount of displacement incurred when treating type III supracondylar humerus fractures in children with crossed pinning versus lateral-entry only technique. Overall complication rate, loss of reduction, iatrogenic neurovascular injury, and pin tract infection rates between the two cohorts will be evaluated. The study population will comprise all patients less than ten years of age presenting to Scottish Rite Hospital during the study period with a type III supracondylar fracture managed by the Children's Healthcare of Atlanta Orthopedic Group. All patients will be randomized to one specific treatment arm based on surgeon preference established at the onset of the study. The hypothesis to be tested is that no difference in amount of displacement or overall complication rate is present between these two techniques. Radiographic parameters measured pre-operatively, immediately post-operatively and four weeks post-operatively will be quantitatively evaluated and compared. Chart reviews to determine complications during the treatment period will be made. Pre-study power analysis and post-study statistical analysis will be performed.

Key facts

Study ID

NCT00207870

Run by

Children's Healthcare of Atlanta

People needed

0

Starts

2006-10-01

Expected to finish

2008-09-01

Last updated by the study team

2014-07-22

Who can join

Age: 3 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Closed, Gartland's type III extension supracondylar humerus fractures requiring closed reduction and pinning.

You may not qualify if…

• Age greater than ten
• Open fracture
• Need for open reduction in the operating room
• Need for vascular repair of the ipsilateral extremity

Where it is running

• Children's Healthcare of Atlanta at Scottish Rite — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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