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Comparison of Crossed Pin Versus Lateral-Entry Pin Fixation for Type II Supracondylar Fractures in Children: A Prospective, Randomized Trial
| City: |
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Atlanta |
| State: |
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Georgia |
| Zip Code: |
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30342 |
| Conditions: |
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Type II Supracondylar Fractures |
| Purpose: |
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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.
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| Study Summary: |
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Pre-operative consent forms for study participation will be reviewed with all families at
the time of the pre-operative visit. Screening will be performed at the time of evaluation
in the emergency room. Patients will be assigned to a particular group based on the surgeon
that performs their surgery. Each surgeon at the onset of the study will commit to one
technique of operative management with the understanding that this technique may be
abandoned by the surgeon in any case where it is felt to be inadequate. Changing technique
will be considered a failure of the technique. Data regarding the treatment will be
collected from the chart and x-rays at the time of treatment and at follow up visits in the
orthopedic office.
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| Criteria: |
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Inclusion Criteria:
- Closed, Gartland's type III extension supracondylar humerus fractures requiring
closed reduction and pinning.
Exclusion Criteria:
- Age greater than ten
- Open fracture
- Need for open reduction in the operating room
- Need for vascular repair of the ipsilateral extremity
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| NCT ID: |
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NCT00207870 |
| Primary Contact: |
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Principal Investigator
John Blanco, MD
Children's Orthopaedics of Atlanta
Elena Morales, BS
Email: elena.morales@choa.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Atlanta, Georgia 30342
United States
Elena Morales, BS
Email: elena.morales@choa.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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