Type II Supracondylar Fractures in Children

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00207870
First received: September 13, 2005
Last updated: July 21, 2014
Last verified: July 2011
  Purpose

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.


Condition
Type II Supracondylar Fractures

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Comparison of Crossed Pin Versus Lateral-Entry Pin Fixation for Type II Supracondylar Fractures in Children: A Prospective, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all patients less than 10 with a supracondylar fx

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207870

Locations
United States, Georgia
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: John Blanco, MD Children's Orthopaedics of Atlanta
  More Information

No publications provided

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00207870     History of Changes
Other Study ID Numbers: Type II Supracondylar FX
Study First Received: September 13, 2005
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
Type II Supracondylar Fracture
Orthopaedics

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014