- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207870
Type II Supracondylar Fractures in Children
Comparison of Crossed Pin Versus Lateral-Entry Pin Fixation for Type II Supracondylar Fractures in Children: A Prospective, Randomized Trial
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30342
- Children's Healthcare of Atlanta at Scottish Rite
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Blanco, MD, Children's Orthopaedics of Atlanta
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Type II Supracondylar FX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type II Supracondylar Fractures
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University of British ColumbiaTerminatedType I Supracondylar Fracture of the HumerusCanada
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Baylor College of MedicineWithdrawnSupracondylar Humerus FracturesUnited States
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Wake Forest University Health SciencesCompleted
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Chang Gung Memorial HospitalUnknownSupracondylar Humerus FractureTaiwan
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Baylor College of MedicineTerminatedSupracondylar FracturesUnited States
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Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedSupracondylar Humerus Fracture | Pediatric Fractures
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Seattle Children's HospitalCompletedSupracondylar Humerus FractureUnited States
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Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedSupracondylar Humerus Fracture
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KK Women's and Children's HospitalCompletedPediatric Supracondylar Humeral FractureSingapore
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Children's Mercy Hospital Kansas CityEnrolling by invitationSupracondylar Humerus FractureUnited States